Covidien              Jan-03-2014        Puritan Bennett 840 ventilator systems software – Puritan Bennett 840 ventilator systems software part number 4-070212-85; revision AB-AG.The intended use of the product is to provide mechanical ventilation to patients.                              Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error.                   

Codman & Shurtleff; Inc.              Jan-23-2014        n-Butyl Cyanoacrylate  (n-BCA) Liquid Embolic System – TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System:  One 1 g tube of n-BCA; one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum PowderProduct Code: 631-500The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.                            Incorrect instructions for use (IFU).                       

Codman & Shurtleff; Inc.              Jan-23-2014        n-Butyl Cyanoacrylate  (n-BCA) Liquid Embolic System – TRUFILL n-Butyl Cyanoacrylate  (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA; one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum PowderProduct Code:  631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.                   Incorrect instructions for use (IFU).                          

GE Healthcare It               Jan-02-2014        Centricity Laboratory System – The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities; e.g.; the storing and delivering of analytical results. It is a specially designed data program application (software); which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run; steer; or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities; including a central laboratory or in a multiple laboratory environment servicing satellite laboratories; reference laboratories; clinics; etc. Centricity Laboratory System is not intended for direct patient contact.  The Centricity Laboratory System product is designed to facilitate the general clinical; anatomic pathology and cytology laboratory workflow such as order entry; results entry; instrument interfacing; results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists; technicians; analyst and other trained/site authorized system users        GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instrument Interface (IF) where free-text sent from IM is not being transcribed into free-text in iNET. The instrument may upload results to IF/iNET when order/request is not yet in IF/iNET. In such a situation; test level supporting free-text sent from the instrument is discarded (not captured).

Siemens Healthcare Diagnostics; Inc.      Jan-03-2014        HB1C Flex(R) Reagent Cartridge – HB1C Flex(R) Reagent Cartridge (DF105A; Siemens Material Number 10483822) for the Dimension(R) Clinical Systems.Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.   Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.

Integra LifeSciences Corp.            Jan-03-2014        Integra Small Rickham -Style Reservoir – Integra Small Rickham -Style ReservoirRx Only Sterile for Single Use OnlyIntegra NeuroSciences 311 Enterprise Drive Plainsboro; NJ 08536 USA Made in the USANL 850-1121Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies; for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.      Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type package were found prior to use but after the sterile package was open

Siemens Healthcare Diagnostics; Inc.      Jan-03-2014        HbA1c Flex(R) reagent cartridge – HbA1c Flex(R) reagent cartridge (K3105A; Siemens Material Number 10470481) for the Dimension(R) Clinical Systems.Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.   Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.

Integra LifeSciences Corp.            Jan-03-2014        Integra Large Rickham -Style Reservoir – Integra Large Rickham -Style ReservoirRx Only Sterile for Single Use OnlyIntegra NeuroSciences 311 Enterprise Drive Plainsboro; NJ 08536 USA Made in the USANL 850-1132Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies; for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.      Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type packages were found prior to use but after the sterile package was open.

RTI Surgical; Inc.                Jan-03-2014        C-Plus – C-Plus" 10mm x 12mm Webless implantsPioneer Surgical’s C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended for use with supplemental fixation and autograft. These implants are manufactured from PEEK (Polyaryletheretherketone) polymer with tantalum marker pins for radiographic visualization.            As the result of a recent internal review of regulatory documents; we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR).  While the use of this device as a partial VBR is unlikely due to the size of the device; use of this device as a partial VBR could result in a s

Trans American Medical; Inc.      Jan-03-2014        Spectre Wireless Footswitch/Handswitch system – Spectre Wireless Footswitch/Handswitch system Model 98/99; Model FDS; Model FDB.The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number                TransAmerican Medical Imaging is recalling certain lots of TMI Spectre Wireless Footswitch/Hand switch for GE OEC 9800/9900 and Philips FDS and FDB Cath Labs due to potential safety issue related to the use of this product producing uncommanded X-ray.

Materialise USA LLC        Jan-03-2014        Signature – REF 42-411571  QTY 1 CATALOG  CAUTION. SEE INSTRUCTIONS FOR USESIGNATUREM PKA GDE/MDL SET SML-MPDD…..R-FEB55RKA-T JA-A01 05551PKA POST CUT SML-PKA MICROPLASTYCUSTOM-MADE DEVICEnon-sterileThe Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.    Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.

SpineFrontier; Inc.           Jan-03-2014        PedFuse Bone Probe – PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.                Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.

Aesculap; Inc.    Jan-03-2014        Aesculap Hi-Line XXS handpiece – Aesculap Hi-Line XXS handpieceHi-Line XXS handpieces are used with the HiLAN and microspeed motor systems to hold burrs which cut and shape bone.            Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece.

Carestream Health Inc.  Jan-03-2014        DRX-Revolution Mobile X-Ray System – Carestream DRX-Revolution Mobile X-Ray System — Made in U.S.A. by Carestream Health Inc. 150 Verona Street; Rochester; NY . 14608 — The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients; in all patient treatment areas.             It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system.

The Anspach Effort; Inc.                Jan-06-2014        Anspach BLACKMAX-N (Pneumatic motor) and Autolube III – Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control).Cutting and shaping bone.       Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).

Fresenius Medical Care Holdings; Inc.     Jan-06-2014        Fresenius 2008 Series Hemodialysis Machines – Fresenius 2008 Series Hemodialysis Machines:Models: 2008H; 2008K; 2008K2; 2008k@Home; 2008TThe 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure; when conservative therapy is judged to be inadequate. The dialysate delivery machine is used for hemodialysis in hospital; dialysis centers; and at home. The 2008K; 20081(2 and 2008T hemodialysis machines are designed to perform hemodialysis in hospitals and dialysis clinics. They can be used for patients suffering chronic or acute renal failure. The 2008K; 2008K2 and 2008T are designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. The Fresenius 2008K~home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K~home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.     2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup

The Anspach Effort; Inc.                Jan-06-2014        Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome – Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.    Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).

Stryker Instruments Div. of Stryker Corporation                Jan-06-2014        Color Cuff – Stryker Color Cuff; REF 5921-034-135 Disposable Tourniquet Cuffs  34 in x 4 in (86 cm x 10 cm)Single Bladder; Single Port; QuickConnectRx only; STERILE          The Color Cuff Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector.A customer reported having received a luer connector instead of a quick connect fitting. An incorrect connector maylead to an inoperable system due to incompatibility with the Smart Pump.

Welch Allyn Protocol; Inc              Jan-07-2014        Propaq LT 802LT series Vital Signs Monitor – The Propaq LT Series monitors. Model numbers 802LTAN; 802LT0N; and 802LTRN.These devices are indicated for ECG; noninvasive blood pressure (NIBP); respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical; telemetry; and intermediate care floors; hospital emergency departments; transport; emergency medical services; and other healthcare applications.intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients; including neonate; pediatric and adult patients. These devices are indicated for ECG; noninvasive blood pressure (NIBP); respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical; telemetry; and intermediate care floors; hospital emergency departments; transport; emergency medical services; and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.      Welch Allyn will update Propaq 802 Series Vital Signs Monitor; models are 802LTAN; 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could; in rare instances; potentially interrupt device operations.

Smiths Medical ASD; Inc.              Jan-08-2014        Smiths Medical – Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe;  1.0ml 29g x 1/2 inDistributed by:  Cardinal Health; Dublin; OH (Co-Brand)Reference: ED012905-INHypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile; latex free; non-pyrogenic; single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.           Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes

Ansell Sandel Medical Industries LLC       Jan-08-2014        Ansell Sandel Weighted Safety Scalpel – Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #15 BladeManufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth; CA 91311 USAEmergo Europe Molenstraat 15 2513 BH The HagueThe Netherlands Made in ChinaPackaged in MexicoAnsellA manual surgical scalpel blade for making incisions in various general surgical procedures.       Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.

Ansell Sandel Medical Industries LLC       Jan-08-2014        Ansell Sandel Weighted Safety Scalpel – Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 BladeManufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth; CA 91311 USAEmergo Europe Molenstraat 15 2513 BH The HagueThe Netherlands Made in ChinaPackaged in MexicoAnsellA manual surgical scalpel blade for making incisions in various general surgical procedures.       Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.

Ansell Sandel Medical Industries LLC       Jan-08-2014        Ansell Sandel Weighted Safety Scalpel – Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 BladeManufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth; CA 91311 USAEmergo Europe Molenstraat 15 2513 BH The HagueThe Netherlands Made in ChinaPackaged in MexicoAnsellA manual surgical scalpel blade for making incisions in various general surgical procedures.       Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.

Ansell Sandel Medical Industries LLC       Jan-08-2014        Ansell Sandel Weighted Safety Scalpel – Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 BladeManufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth; CA 91311 USAEmergo Europe Molenstraat 15 2513 BH The HagueThe Netherlands Made in ChinaPackaged in MexicoAnsellA manual surgical scalpel blade for making incisions in various general surgical procedures.       Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.

Smiths Medical ASD; Inc.              Jan-08-2014        Smiths Medical – Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe;  0.5ml 29g x 1/2 inReference: 4429-5Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile; latex free; non-pyrogenic; single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.      Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes

Smiths Medical ASD; Inc.              Jan-08-2014        Smiths Medical – Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe;  0.3ml 29g x 1/2 inReference: 4429-3Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile; latex free; non-pyrogenic; single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.      Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes

Ansell Sandel Medical Industries LLC       Jan-08-2014        Ansell Sandel Weighted Safety Scalpel – Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 BladeManufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth; CA 91311 USAEmergo Europe Molenstraat 15 2513 BH The HagueThe Netherlands Made in ChinaPackaged in MexicoAnsellA manual surgical scalpel blade for making incisions in various general surgical procedures.       Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.

Ansell Sandel Medical Industries LLC       Jan-08-2014        Ansell Sandel Weighted Safety Scalpel – Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 BladeManufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth; CA 91311 USAEmergo Europe Molenstraat 15 2513 BH The HagueThe Netherlands Made in ChinaPackaged in MexicoAnsellA manual surgical scalpel blade for making incisions in various general surgical procedures.       Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.

Smiths Medical ASD; Inc.              Jan-08-2014        Smiths Medical – Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe;    0.5ml 29g x 1/2 in. Distributed by: Cardinal Health; Dublin; OH (Co-Brand)Reference: ED052905INHypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile; latex free; non-pyrogenic; single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.       Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes

Invacare Corporation     Jan-08-2014        Tracer IV wheelchairs – Tracer IV wheelchairs; Heavy duty manual wheel chair; 24" seat width; 450 lbs. weight capacity. Distributed by Invacare; Elyria; OH 44035For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.  The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width; 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.

Smiths Medical ASD; Inc.              Jan-08-2014        Smiths Medical – Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe;  1.0ml 29g x 1/2 inReference: 4429-1Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile; latex free; non-pyrogenic; single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.      Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes

Ansell Sandel Medical Industries LLC       Jan-08-2014        Ansell Sandel Weighted Safety Scalpel – Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 BladeManufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth; CA 91311 USAEmergo Europe Molenstraat 15 2513 BH The HagueThe Netherlands Made in ChinaPackaged in MexicoAnsell2215-L Weighted Safety Scalpel; #3L Handle (8.75) with #15 Blade; Yellow Shield with TIME OUT Sleeve (S) 12 per box; 8 boxes per case (96 total scalpels)A manual surgical scalpel blade for making incisions in various general surgical procedures. Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.

On Site Gas Systems Inc.              Jan-08-2014        On SIte Gas Systems – On Site Gas Systems POGS 33C Portable Oxygen Generation System         Heat exchanger hose becomes weak and may fail.

Optimedica Corporation               Jan-08-2014        OptiMedica Catalys – Catalys Precision Laser System (United States) – Catalys-U:Catalys Precision Laser System (International) – Catalys I200-240V ~; 50/60 Hz; 15A;(2) 15A Resettable CB:Tested and complies with FCC Part 15 Class A.OptiMedica1310 Moffett Park DriveSunnyvale; CA 94089The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.                Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat; which may manifest an odor and visible smoke.

Alere San Diego; Inc.      Jan-09-2014        Oral Fluid Drug Screen – Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device; OrALert Oral Fluid Drug ScreenDevice; OrALert Oral Fluid Drug Screen Device with BZO; Reditest On-SiteOral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test.Type of Packaging: 25 individually pouched test devices & collectors in a labeledkit box.The OrALert" Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is animmunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluidspecimen compete against their respective drug conjugates for binding sites on their specific antibody.  Alere initiated this recall of certain lots of the Oral Fluid Drug Scrren Device because the sponge may become dislodged from the Saliva Collector handle prior to or during the oral fluid sample collection process. If the sponge becomes dislodged during the specimen collection process; the donor may inadvertently swallow the sponge which could present a choking risk.

ArthroCare Medical Corporation               Jan-09-2014        ArthroCare Knot Pusher – Arthrocare SPORTS MEDICINE; Knot Pusher; REF 25-3011; LOT #1049402; CON 1; 2013-10; NON-STERILE; Rx only          A sharp edge on the cannulated tip of the device may damage or cut a suture.

The Anspach Effort; Inc.                Jan-09-2014        Anspach Cutters and Attachments – Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments)MCA – MICRO CURVED ATTACHMENT; MCA5-05SD – 0.5MM DIAMOND BALL; 5.6CM; MCA5-06SD – 0.6MM DIAMOND BALL; 5.6CM; MCA5-07SD – 0.7MM DIAMOND BALL; 5.6CM; MCA5-08SD – 0.8MM DIAMOND BALL; 5.6CM; MCA5-15SB – 1.5MM FLUTED BALL; 5.6CM; MCA5-15SD – 1.5MM DIAMOND BALL; 5.6CM; MCA5-1SB – lMM FLUTED BALL; 5.6CM; MCA5-1SD – lMM DIAMOND BALL; 5.6CM; MCA5-2SB – 2MM FLUTED BALL; 5.6CM; MCA5-2SD – 2MM DIAMOND BALL; 5.6CM; MCA7-05SD – 0.5MM DIAMOND BALL; 7.3CM; MCA7-06SD – 0.6MM DIAMOND BALL; 7 .3CM; MCA7-07SD – 0.7MM DIAMOND BALL; 7.3CM; MCA7-08SD – 0.8MM DIAMOND BALL; 7.3CM; MCA7-15SB – 1.5MM FLUTED BALL; 7.3CM; MCA7-15SD 1.5MM DIAMOND BALL; 7.3CM; MCA7-1SB – lMM FLUTED BALL; 7.3CM;  MCA7-1SD –  1 MM DIAMOND BALL; 7 .3CM;  MCA7-2SB – 2MM FLUTED BALL; 7.3CM and MCA7-2SD – 2MM DIAMOND BALL; 7.3CM.The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use; disposable cutter designed for cutting and shaping delicate bone; primary in otology procedures for delicate bone cutting.    During a recent review of documentation Anspach determined that the current directions for use for the MCA cutting burrs and MCA Micro Curved Attachment do not provide clear details regarding the intended use specifically for the MCA burrs.  The MCA burrs are intended for use in delicate bone in otologic procedures such as cochleostomy.  The use of the device in dense bone removal may result in cu

The Anspach Effort; Inc.                Jan-09-2014        REF XMAX***XMax Handpiece – ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort; Inc. 4500 Riverside; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126**Intended for cutting and shaping bone. The firm Anspach Effort of Palm Beach Gardens; FL initiated a voluntary removal of the Pneumatic Drill System; including the motor hand-piece; Auto Lube foot control; without a pressure relief valve (PRV) due to the hand piece’s outer hose can rupture without warning if the air flow is blocked during use..

The Anspach Effort; Inc.                Jan-09-2014        REF MICROMAX***microMax Handpiece – ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort; Inc. 4500 Riverside; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***Intended for cutting and shaping bone.    The firm Anspach Effort of Palm Beach Gardens; FL initiated a voluntary removal of the Pneumatic Drill System; including the motor hand-piece; Auto Lube foot control; without a pressure relief valve (PRV) due to the hand piece’s outer hose can rupture without warning if the air flow is blocked during use..

The Anspach Effort; Inc.                Jan-09-2014        REF IMRI-MOTOR***iMRI Handpiece – ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort; Inc. 4500 Riverside; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***Intended for cutting and shaping bone.    The firm Anspach Effort of Palm Beach Gardens; FL initiated a voluntary removal of the Pneumatic Drill System; including the motor hand-piece; Auto Lube foot control; without a pressure relief valve (PRV) due to the hand piece’s outer hose can rupture without warning if the air flow is blocked during use..

The Anspach Effort; Inc.                Jan-09-2014        REF BLACKMAX-N***Swivel/Angle Motor Assembly – ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort; Inc. 4500 Riverside; Palm Beach Gardens; FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP11 1LA United Kingdom Tel: +441494 616126***Intended for cutting and shaping bone.          The firm Anspach Effort of Palm Beach Gardens; FL initiated a voluntary removal of the Pneumatic Drill System; including the motor hand-piece; Auto Lube foot control; without a pressure relief valve (PRV) due to the hand piece’s outer hose can rupture without warning if the air flow is blocked during use..

EOS Imaging       Jan-09-2014        EOS System X- ray beam – EOS System X- ray beamDigital radiography system used in general radiographic examinations.         EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation ofthe X-ray beam operated by the EOS system during the X-ray acquisition.

GE Healthcare; LLC          Jan-09-2014        GE Healthcare CARESCAPE Patient Data Module – SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)   GE Healthcare has recently become aware of a potential safety issue which affects all Patient  Date Modules produced from April 2007 through June 2010; encompassing Fiscal Week 13; 2007 through 26; 2010 due to fluid ingress into the top cover assembly which can result in heat buildup.

Nova Biomedical Corporation     Jan-09-2014        Nova StatStrip/StatSensor Hospital Blood Glucose Meter – Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter;Rechargeable Lithium BatteriesSingle: 46626; 4 Pack: 46827; 5 Pack: 50436.For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.        Revised Battery Instructions for Removal and Expiration  Date due to battery swelling and cell leakage

ICU Medical; Inc.              Jan-09-2014        17 cm (7”) Ext Set w/NanoClave; 2 Gang 4-Way NanoClave – 17 cm (7”) Ext Set w/NanoClave; 2 Gang 4-Way NanoClaveStopcock; Rotating Luer; Part No. A1000; Item No. 011-AC103The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.            ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        120" 10 Drop Primary Set w/2 BCV-CLAVE; Remv 2 Gang CLAVE – 120" 10 Drop Primary Set w/2 BCV-CLAVE; Remv 2 Gang CLAVEStopcock; Remv CLAVE Stopcock; NanoClave T-Connector; RotatingLuer; 2 Ext; Part No. A1000; Item No. SC125The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.        ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        87" (221 cm) Appx 2.9 ml; Smallbore Trifuse Ext Set w/NanoClave; 0.2 – 87" (221 cm) Appx 2.9 ml; Smallbore Trifuse Ext Set w/NanoClave; 0.2Micron Filter; 4 Clamps; Rotating Luer; 2 Exts; Drop-In NanoClave; Part No. A1000; Item No. A1078The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.       ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave; 2 Anti-Syphon – 184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave; 2 Anti-SyphonValves; 0.2 Micron Positive Filter; BCV-Clave; NanoClave TConnector;Rotating Luer; Part No. A1000; Item No. 011-A1095The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.   ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave; Orange Ring; 2 – 31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave; Orange Ring; 2Anti Syphon Valves; 0.2 Micron Postive Filter; Clamp; NanoClave TConnector;Rotating Luer; Part No. A1000; Item No. 011-A1097The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.   ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        NanoClave Stopcock – NanoClave Stopcock; Part No. A1000; Item No. 011-AC100The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        5" (13 cm) Appx 0.23 ml; Smallbore Ext Set w/NanoClave"; Clamp; – 5" (13 cm) Appx 0.23 ml; Smallbore Ext Set w/NanoClave"; Clamp;Rotating Luer; Part No. A1000; Item No. Z3845The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.            ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave (Yellow; – 183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave (Yellow;Green Rings); 4 Anti-Syphon Valves; 0.2 Micron Positive Filter; BCVClave; NanoClave T-Connector; Rotating Luer; Part No. A1000; Item No. 011-A1094The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.           ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        8" (20 cm) Appx 0.49 ml; Smallbore Bifuse Ext Set w/2 NanoClave"; 2 – 8" (20 cm) Appx 0.49 ml; Smallbore Bifuse Ext Set w/2 NanoClave"; 2Clamps; Luer Lock; Part No. A1000; Item No. A1069The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate; 4 – 13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate; 4NanoClave; Rotating Luer;  Part No. A1000; Item No. A1080The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        6" (15 cm) Appx 0.56 ml; Smallbore Trifuse Ext Set w/3 NanoClave"; 3 – 6" (15 cm) Appx 0.56 ml; Smallbore Trifuse Ext Set w/3 NanoClave"; 3Clamps; Luer Lock; Part No. A1000; Item No. K7097-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        11" Smallbore Bifuse Ext Set w/1.2 Micron Filter; NanoClave"; 3 – 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter; NanoClave"; 3Clamps; Rotating Luer; Part No. A1000; Item No. K7105-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        7" (18 cm) Appx 0.29 ml; Smallbore Ext Set w/MicroClave Clear; – 7" (18 cm) Appx 0.29 ml; Smallbore Ext Set w/MicroClave Clear;NanoClave"; Clamp; Rotating Luer;  Part No. A1000; Item No. K7088-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        7" (18 cm) Appx 0.26 ml; Smallbore Ext Set w/MicroClave Clear; – 7" (18 cm) Appx 0.26 ml; Smallbore Ext Set w/MicroClave Clear;NThe ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.anoClave"; Clamp; Luer Lock;  Part No. A1000; Item No. K7089-001   ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        7" (18 cm) Appx 0.29 ml; Smallbore Ext Set w/MicroClave Clear; – 7" (18 cm) Appx 0.29 ml; Smallbore Ext Set w/MicroClave Clear;NanoClave; Clamp; Rotating Luer; Part No. A1000; Item No. A1007The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        6" (15 cm) Appx 0.26 ml; Smallbore Ext Set w/Clamp; NanoClave TConnector – 6" (15 cm) Appx 0.26 ml; Smallbore Ext Set w/Clamp; NanoClave TConnector;Rotating Luer; Part No. A1000; Item No. A1001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        8" (20 cm) Appx 0.43 ml; Smallbore Bifuse Ext Set w/2 NanoClave"; 2 – 30" (76 cm) Appx 3.7 ml; Ext Set w/Remv 2 Gang CLAVE Stopcock;Remv CLAVE Stopcock; NanoClave T-Connector; Rotating Luer; 1Ext; Part No. A1000; Item No. SC124The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.       ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        6" (15 cm) Appx 0.24 ml; Smallbore Ext Set w/MicroCLAVE Clear; – 6" (15 cm) Appx 0.24 ml; Smallbore Ext Set w/MicroCLAVE Clear;Clamp; NanoClave T-Connector; Rotating Luer; Item # A1003; Lot # 2773812.The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.                ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        11" Smallbore Bifuse Ext Set w/1.2 Micron Filter; NanoClave"; 3 – 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter; NanoClave"; 3Clamps; Rotating Luer; Part No. A1000; Item No. A1052The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.            ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        7" (18 cm) Appx 0.31 ml; Smallbore Ext Set w/Remv MicroClave Clear; – 7" (18 cm) Appx 0.31 ml; Smallbore Ext Set w/Remv MicroClave Clear;NanoClave" T-Connector; Clamp; Rotating Luer;  Part No. A1000; Item No. K7090-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.   ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        7" (18 cm) Appx 0.24 ml; Smallbore Ext Set w/NanoClave"; Clamp; Luer – 7" (18 cm) Appx 0.24 ml; Smallbore Ext Set w/NanoClave"; Clamp; LuerLock; Part No. A1000; Item No. K7095-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.            ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        6.5" (16.5 cm) Appx 0.30 ml; Smallbore Pressure Infusion (400psig) – 6.5" (16.5 cm) Appx 0.30 ml; Smallbore Pressure Infusion (400psig)Ext Set w/Remv MicroClave Clear; NanoClave T-Connector;Purple Clamp; Rotating Luer; Item # A1099; Lot # 2791393.The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.   ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        8" (20 cm) Appx 0.43 ml; Smallbore Bifuse Ext Set w/2 NanoClave"; 2 – 8" (20 cm) Appx 0.43 ml; Smallbore Bifuse Ext Set w/2 NanoClave"; 2Clamps; Luer Lock; Part No. A1000; Item No. K7107-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        6" (15 cm) Appx 0.27 ml; Smallbore Ext Set w/Clamp; NanoClave" TConnector; – 6" (15 cm) Appx 0.27 ml; Smallbore Ext Set w/Clamp; NanoClave" TConnector;Rotating Luer;  Part No. A1000; Item No. K7084-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.                ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        10" (25 cm) Appx 0.41 ml; Smallbore Ext Set w/MicroClave Clear; – 10" (25 cm) Appx 0.41 ml; Smallbore Ext Set w/MicroClave Clear;NanoClave"; Clamp; Rotating Luer; Part No. A1000; Item No. K7101-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        103" (262 cm) Appx 3.9 ml; Smallbore Bifuse Ext Set w/NanoClave"; – 103" (262 cm) Appx 3.9 ml; Smallbore Bifuse Ext Set w/NanoClave";Anti-Siphon Valve; Check Valve; 2 Clamps; Luer Lock;  Part No. A1000; Item No. A1093The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.   ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        6" (15 cm) Appx 0.27 ml; Smallbore Ext Set w/Clamp; NanoClave" TConnector – 6" (15 cm) Appx 0.27 ml; Smallbore Ext Set w/Clamp; NanoClave" TConnectorw/Luer Slip;  Part No. A1000; Item No. K7085-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.                ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        7" (18 cm) Appx 0.31 ml; Smallbore Ext Set w/2 NanoClave"; Clamp; – 7" (18 cm) Appx 0.31 ml; Smallbore Ext Set w/2 NanoClave"; Clamp;Rotating Luer; Part No. A1000; Item No. K7099-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        5" Smallbore Ext Set w/MicroClave T-Connector; Clamp; Luer Slip; – 5" Smallbore Ext Set w/MicroClave T-Connector; Clamp; Luer Slip; Item # B3303-T; Lot # 2791243.The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.           ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        28" (71 cm) Appx 1.0 ml; Smallbore Ext Set w/Anti-Siphon Valve; – 28" (71 cm) Appx 1.0 ml; Smallbore Ext Set w/Anti-Siphon Valve;MicroClave T-Connector; Clamp; Rotating Luer; Item # B33071-T; Lot # 2791245.The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.                ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        NanoClave Connector – NanoClave Connector; Part No. A1000; Item No. 011-A1000; 061-A1000; A1000; K7083-001; Z3769The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.        ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        5" Smallbore Ext Set w/MicroClave T-Connector; Clamp; Rotating – 5" Smallbore Ext Set w/MicroClave T-Connector; Clamp; RotatingLuer; Item # B3304-T; Lot # 2791244.The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.           ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        14" (36 cm ) Appx 0.50 ml; Smallbore Ext Set w/MicroClave Clear; – 14" (36 cm ) Appx 0.50 ml; Smallbore Ext Set w/MicroClave Clear;NanoClave; 2 Clamps; Rotating Luer;  Part No. A1000; Item No. A1081The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        10" (25 cm) Appx 2.9 ml; Trifuse Ext Set w/3 MicroClave Clear; Tri- – 10" (25 cm) Appx 2.9 ml; Trifuse Ext Set w/3 MicroClave Clear; Tri-Connector; NanoClave" T-Connector; 4 Clamps (Red; White; Blue);Rotating Luer;  Part No. A1000; Item No. K7091-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.   ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        8" Ext Set w/NanoClave" Stopcock; Clamp; Rotating Luer – 8" Ext Set w/NanoClave" Stopcock; Clamp; Rotating Luer;  Part No. A1000; Item No. AC102The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.   ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

Midmark  Corp dba Progeny Inc                Jan-09-2014        Vantage Panoramic X-Ray System – The Vantage Digital Panoramic System delivers high-value features standard on every system: – Five pre-programmed exam settings; including bitewing; minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and patient experience. – Progeny Clarity Enhanced Filter Set provides superior diagnostic imaging quality – Exclusive Focal Trough Alignment reminder assists in consistent patient positioning – Progeny Imaging software included for download on an unlimited number of operatory workstations with no additional costs – Exclusive VantageTrust remote support and training service offered at no charge for the first 60 days of use – Ceph upgradeable for expanded extraoral exam capabilities – The Progeny Vantage Panoramic System s proudly designed and manufactured in the USA; 2013 Midmark Corporation; 675 Heathrow Drive Lincolnshire; IL 60069; 847-415-9800 Toll-free 888-924-3800       An error was identified in the Real Time Controller (RTC) firmware versions 3.0; 3.1; 3.2; and 3.3 used in Vantage Panoramic X-Ray systems. The error may cause the column of the Vantage Panoramic X-Ray unit to continue moving vertically despite the release of the movement control button (i.e. failure to stop").

ICU Medical; Inc.              Jan-09-2014        7" (18 cm) Appx 0.33 ml; Smallbore Ext Set w/NanoClave"; Clamp; – 7" (18 cm) Appx 0.33 ml; Smallbore Ext Set w/NanoClave"; Clamp;Rotating Luer; Part No. A1000; Item No. K7103-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.            ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        6" (15 cm) Appx 0.58 ml; Smallbore Trifuse Ext Set w/3 NanoClave; 3 – 6" (15 cm) Appx 0.58 ml; Smallbore Trifuse Ext Set w/3 NanoClave; 3Clamps; Rotating Luer; Part No. A1000; Item No. 011-A1029The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        7" (18cm) Appx 0.32 ml; Smallbore Ext Set w/Remv MicroCLAVE Clear; – 7" (18cm) Appx 0.32 ml; Smallbore Ext Set w/Remv MicroCLAVE Clear;NanoClave T-Connector; Clamp; Rotating Luer; Part No. A1000; Item No. A1009The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.   ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        8" (20 cm) Appx 0.51 ml; Smallbore Ext Set w/MicroCLAVE Clear; 0.2 – 8" (20 cm) Appx 0.51 ml; Smallbore Ext Set w/MicroCLAVE Clear; 0.2Micron Filter; NanoClave T-Connector; Clamp; Rotating Luer; Part No. A1000; Item No. A1014The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.   ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        78" Ext Set w/2 BCV-Clave; Remv 2-Gang 4-Way Stopcocks; – 78" Ext Set w/2 BCV-Clave; Remv 2-Gang 4-Way Stopcocks;NanoClave" T-Connector; 4 Clamps; Rotating Luer; 3 Exts;  Part No. A1000; Item No. K7094-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.                ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        6" (15 cm) Appx 0.26 ml; Smallbore Ext Set with NanoClave T-Connector; – 6" (15 cm) Appx 0.26 ml; Smallbore Ext Set with NanoClave T-Connector;Clamp; Luer Slip; Part No. A1000; Item No. 011-A1002The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        8" Smallbore Pentafuse Ext Set w/5 NanoClave"; 5 Clamps; Rotating – 8" Smallbore Pentafuse Ext Set w/5 NanoClave"; 5 Clamps; RotatingLuer; Part No. A1000; Item No. A1070The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.           ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        78" Ext Set w/Check Valve; CLAVE Clear; Remv 2 Gang 4-Way – 78" Ext Set w/Check Valve; CLAVE Clear; Remv 2 Gang 4-WayStopcocks; NanoClave; NanoClave T-Connector; 4 Clamps; RotatingLuer; 3 Ext; Part No. A1000; Item No. A1026The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.   ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        10" (25 cm) Appx 0.38 ml; Smallbore Ext Set w/Remv MicroClave – 10" (25 cm) Appx 0.38 ml; Smallbore Ext Set w/Remv MicroClaveClear; NanoClave"; Clamp; Luer Lock; Part No. A1000; Item No. K7102-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        13" Pentafuse Smallbore Ext Set w/NanoClave"; 1.2 Micron Filter; 3 – 13" Pentafuse Smallbore Ext Set w/NanoClave"; 1.2 Micron Filter; 3MicroClave Clear (Yellow; Red; Green Rings); 6 Clamps; Rotating Luer; Part No. A1000; Item No. K7106-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.        ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave ( Light Blue; – 17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave ( Light Blue;Lavender Rings); 3 Anti-Syphon Valves; Rotating Luer; Item #011-A1096; Lot # 2796668.The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.   ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        106" (269 cm) Appx 7.8 ml; Transfer Set w/Check Valve; NanoClave" TConnector; Anti-Siphon Valve; 2 C – 106" (269 cm) Appx 7.8 ml; Transfer Set w/Check Valve; NanoClave" TConnector; Anti-Siphon Valve; 2 Clamps; Luer Lock;  Part No. A1000; Item No. K7093-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.   ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        5" Smallbore Ext Set w/MicroClave T-Connector; Clamp; Rotating – 5" Smallbore Ext Set w/MicroClave T-Connector; Clamp; RotatingLuer; Item # B33101-T; Lot # 2791358.The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.           ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        6" (15 cm) Appx 0.37 ml; Smallbore Bifuse Ext Set w/2 NanoClave"; 2 – 6" (15 cm) Appx 0.37 ml; Smallbore Bifuse Ext Set w/2 NanoClave"; 2Clamps; Luer Lock; Part No. A1000; Item No. K7096-001The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.      ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

ICU Medical; Inc.              Jan-09-2014        10" Smallbore Pentafuse Ext Set w/5 NanoClave"; 5 Clamps; Rotating – 10" Smallbore Pentafuse Ext Set w/5 NanoClave"; 5 Clamps; RotatingLuer; Part No. A1000; Item No. A1071The ICU Needleless Connector is a single use; sterile; non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.            ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

Radiometer America Inc               Jan-10-2014        pO2 D999 membrane units – pO2 D999 membrane units. Distributed by Radiometer America; Inc.; Westlake; OH 44145pO2 membrane units; ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).                RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner solution for pCO2 membrane units. This solution is a salt solution similar to the pO2 inner solution; but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current; causing the membrane unit to fail the following Cal2 calibration.

Boston Scientific Corporation     Jan-10-2014        Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm – Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mmInjects BelowUPN :M00547140     Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size

Boston Scientific Corporation     Jan-10-2014        Boston Scientific Extractor Pro XL Retrieval Balloon Catheter – Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects AboveUPN: M00547100The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon.          Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size

Boston Scientific Corporation     Jan-10-2014        Boston Scientific Extractor Pro XL Retrieval Balloon Catheter – Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects AboveUPN: M00547110  Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size

King Systems Corp.         Jan-10-2014        King Systems KLTSD414 airway – King Systems KLTSD414Quantity;  5    PER CASE KING LTSDKIT SIZE 4King LT(S)-DTMsupraglottic airwayIdentification Part Number(s): KLTSD414KING LTSD KIT/KIT/TROUSSE/KIT  SIZE 4Contents:   1 – KLTSD Size 4……(155 – 180cm)  .. 1 – 60cc Syringe  1 – Sterile  Lubricant   32-5332  05/10Intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration.     KLTD214 airways found inside KLTSD414 packages.  The KLTSD414 airway has a lumen for use of a gastric suction tube; the KLTD214 airway does not include a lumen for a gastric suction tube.

Draeger Medical Systems; Inc.   Jan-10-2014        Draeger – Draeger Infinity Acute Care System Monitoring Solution                After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused; the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.

The Anspach Effort; Inc.                Jan-10-2014        – Anspach MCA Cutting Burr; DFU Rx OnlyDesigned for cutting and shaping delicate bone; primarily in otology procedures   Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.

Biomet; Inc.        Jan-10-2014        Locking Cortical Screw – Locking Cortical Screw3.5mmX38mmREF 8161-35-038                3.5mmx38mm Locking Cortical Screw; implants are being recalled since an investigation identifiedthat a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.

Leica Biosystems Newcastle Ltd.               Jan-10-2014        BOND Polymer Refine Red Detection – Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bond Polymer Refine Red Detection is a biotin-free; polymeric alkaline phosphate (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies.This detection system is for in vitro diagnostic use. Bond Polymer Refine Red Detection is a biotin-free; polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed; paraffin-embedded tissue on the BOND automated system. The clinical interpretation of any staining or its absence should be complemented by morphological studies. Proper controls should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist. The Bond Polymer Refine Red Detection must be used with laboratory best practice in the use of tissue controls. For assurance; laboratories should stain each patient sample in conjunction with positive; negative and other tissue specific controls as needed.               The affected lots of the product may contain a contaminant of fungus that can cause a loss of staining sensitivity and/or obstructions to fluid delivery to the slide.

Boston Scientific Corporation     Jan-11-2014        Boston Scientific PLUS – TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration)Universal Product Number (UPN):M00561420.Distributed by: Boston Scientific; Natick; MA. Manufactured by: Horizons International Corp.; Costa RicaIntended to be used in flexible endoscopes as a retrieval device for foreign body objects; such as polyps and food boluses.          Sterility of device may be compromised due to lack of pouch seal integrity

Boston Scientific Corporation     Jan-11-2014        Boston Scientific PLUS – TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration)Universal Product Number (UPN):M00561412.Distributed by: Boston Scientific; Natick; MA. Manufactured by: Horizons International Corp.; Costa RicaIntended to be used in flexible endoscopes as a retrieval device for foreign body objects; such as polyps and food boluses.          Sterility of device may be compromised due to lack of pouch seal integrity

Boston Scientific Corporation     Jan-11-2014        Boston Scientific Twister PLUS – TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration)Universal Product Number (UPN):M00561421.Distributed by: Boston Scientific; Natick; MA. Manufactured by: Horizons International Corp.; Costa Rica.Intended to be used in flexible endoscopes as a retrieval device for foreign body objects; such as polyps and food boluses.          Sterility of device may be compromised due to lack of pouch seal integrity

Boston Scientific Corporation     Jan-11-2014        Boston Scientific TWISTER – TWISTER PLUS 22mm RotatableRetrieval Device (Box of 5 configuration)Universal Product Number (UPN): M00561411.Distributed by: Boston Scientific; Natick; MA. Manufactured by: Horizons International Corp.; Costa Rica.Intended to be used in flexible endoscopes as a retrieval device for foreign body objects; such as polyps and food boluses.          Sterility of device may be compromised due to lack of pouch seal integrity

Boston Scientific Corporation     Jan-11-2014        Boston Scientific PLUS – TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects; such as polyps and food boluses.Universal Product Number (UPN):M00561422Distributed by: Boston Scientific; Natick; MA. Manufactured by: Horizons International Corp.; Costa Rica.         Sterility of device may be compromised due to lack of pouch seal integrity

Boston Scientific Corporation     Jan-11-2014        Boston Scientific TWISTER – TWISTER PLUS 22mm RotatableRetrieval Device (Box of 1 configuration)Universal Product Number (UPN): M00561410.Distributed by: Boston Scientific; Natick; MA. Manufactured by: Horizons International Corp.; Costa Intended to be used in flexible endoscopes as a retrieval device for foreign body objects; such as polyps and food boluses. Sterility of device may be compromised due to lack of pouch seal integrity

The Anspach Effort; Inc.                Jan-11-2014        Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips – Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only                Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. As a result; it is possible to have a breach in the sterile barrier.

GE Healthcare; LLC          Jan-11-2014        Optima Mobile X-ray System – GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems.  Model numbers  5555000-5; 5555000-6; and 5421698.       There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade; and Optima XR220amx Mobile X-ray Systems.  Intermittently when a large number of patient exams are retrieved from the HIS/RIS system; the exams when displayed on the mobile x-ray system are not properly displayed.  If the user continues to attempt to select one of the exams w

The Anspach Effort; Inc.                Jan-13-2014        Anspach Carbide Cutting Burrs – Anspach Carbide Cutting Burrs & Drums:2MM Carbide Fluted Ball; Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-CAnspach cutting burrs are intended for cutting and shaping bone; including the spine and cranium        Some carbide cutting burr fractured during use.

The Anspach Effort; Inc.                Jan-13-2014        Anspach Carbide Cutting Burrs – Anspach Carbide Cutting Burrs & Drums:1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMCAnspach cutting burrs are intended for cutting and shaping bone; including the spine and cranium  Some carbide cutting burr fractured during use.

The Anspach Effort; Inc.                Jan-13-2014        Anspach Carbide Cutting Burrs – Anspach Carbide Cutting Burrs:2MM Carbide Fluted Ball; Standard; 8 Flutes – part #QD8-2SB-C-8F; 4MM Carbide Fluted Ball; 10 Flutes – part # QD8-4B-C-10F5MM Carbide Fluted Ball; 10 Flutes – part #QD8-5B-C-10F7MM Carbide Fluted Ball; 14 Flutes – part #QD8-7B-C-14FAnspach cutting burrs are intended for cutting and shaping bone; including the spine and cranium             Some carbide cutting burr fractured during use.

The Anspach Effort; Inc.                Jan-13-2014        Anspach Carbide Cutting Burrs – Anspach Carbide Cutting Burrs:1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L; 1MM Carbide Fluted ball; Extended part # S-1B-C; 1MM Carbide Fluted ball part # S-SB-C; 2MM Carbide Fluted ball part # S-2SB-C; 3MM Carbide Fluted ball Extended part # S-3B-C; 3MM Carbide Fluted ball part # S-3SB-C; 4MM Carbide Fluted ball part # S-4B-C; 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C; 5MM Carbide Fluted ball part # S-5B-C; and 6MM Carbide Fluted ball part # S-6B-C.Anspach cutting burrs are intended for cutting and shaping bone; including the spine and cranium                Some carbide cutting burr fractured during use.

Zimmer; Inc.       Jan-13-2014        Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin); 40.8 g Methyl Acrylate Copol – Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin); 40.8 g Methyl Acrylate Copolymer; 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin; Distributed by Zimmer Dover; OH 44522The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.                The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.

GE Healthcare It               Jan-14-2014        Merge (Cedara) Mammo – Merge Mammo is a multi-modality; vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices; including digital mammography; ultrasound; MRI and CT.Two and three dimensional image review; manipulation; analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital. Productivity-Enhancing Second Console Workstations – Workstations designed to perform automated; routine tasks such as image review; printing and archiving as well as post processing capabilities that enable special services for referring physicians. Diagnostic Review Workstations – Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning through flexible and interactive manipulation of multi-modal softcopy image including the use of prosthetic template overlays; and including mammography. Physician’s Review Workstations – Workstations designed to give easy and economic access to multi-modality softcopy images in multiple locations within and outside the hospital. (e.g. teleconferencing; teleradiology etc.) Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.     There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo viewer. The Merge Mammo viewer can load and display images not in synch with the selected or highlighted images in the thumbnail navigator. This incorrect image display issue could result in an inaccurate reading on the Merge Mammo workstation. This could result in a missed intervention or mis-diagnosis.

Ge Healthcare It               Jan-14-2014        GE Centricity PACS (Versions 3.1.1.2 or later) – Centricity PACS System versions 3.X and higher and 4.X and higherProduct Usage:  The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals; including radiologists; physicians; technologists; clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. the workstation interface provides the user with a means to display; manipulate; archive; print; and export images when connected with the Centricity PACS infrastructure.          There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring from the source to a destination server. When another process in the destination server attempts to access the same object or table; the transfer process of a particular image may be terminated. Once ter

Remel Inc            Jan-14-2014        Oxoid Antimicrobial Susceptibility Testing Disc; MEM10; REF: CT0774B; 10 mcg meropenem – Oxoid Antimicrobial Susceptibility Testing Disc; MEM10; REF: CT0774B; 10 mcg meropenem;  Packed in packs containing 5 cartridges per pack; 50 discs per cartridge. Firm name on the label is Oxoid; Ltd.; Basingstoke; United Kingdom.Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.              Individual discs in the lot may not be sufficiently impregnated with antibiotic; resulting in smaller than expected zone sizes.

Vital Diagnostics; Inc.      Jan-14-2014        Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use – Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use.PN 55285For the quantitative measurement of calcium in plasma and serum           High positive calcium bias on plasma sample versus results on serum

Vital Diagnostics; Inc.      Jan-14-2014        Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use – Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic UsePN: 1429For the quantitative measurement of calcium in plasma and serum           High positive calcium bias on plasma sample versus results on serum

Advanced Sterilization Products                Jan-14-2014        STERRAD 50 Sterilization System – STERRAD 50 Sterilization System; Product Code: 10050The STERRAD 50 Sterilization System is a general purpose; low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.                Advanced Sterilization Products (ASP) is recalling the STERRAD NX; STERRAD 50; and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

Advanced Sterilization Products                Jan-14-2014        STERRAD NX Sterilization System – STERRAD NX Sterilization System; Product Code: 10033The STERRAD NX Sterilization System is a general purpose; low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments.                Advanced Sterilization Products (ASP) is recalling the STERRAD NX; STERRAD 50; and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

Advanced Sterilization Products                Jan-14-2014        STERRAD 50 Sterilization System – STERRAD 100S Sterilization System; Product Code: 10101The STERRAD 100S Sterilization System is a general purpose; low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.                Advanced Sterilization Products (ASP) is recalling the STERRAD NX; STERRAD 50; and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

GE Healthcare; LLC          Jan-14-2014        GE Healthcare Carescape Patient Data Module – GE Healthcare Carescape Patient  Data ModuleThe Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult; pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.           GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loadedmounting latch of PDMs produced from April 2007 through December 2012.

Atrium Medical Corporation        Jan-14-2014        Atrium Medical Oasis Dry Suction Water Seal ATS – Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System  Chest Drain with in-line connectors Product Code:  3650-100.To evacuate air and/or fluid from the chest cavity or mediastinum.                Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation        Jan-14-2014        Atrium Medical Ocean Water Seal Chest Drain ATS – Atrium Ocean Water Seal Chest Drain ATS  (Autotransfusion) Blood Recovery System  Dual patient lines with stopcock and in-line connectorsProduct Code: 2052-000.To evacuate air and/or fluid from the chest cavity or mediastinum.  Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation        Jan-14-2014        Atrium Medical Oasis Dry Suction Water Seal ATS – Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System  Chest Drain  Dual patient lines; Product Code:  3652-100.To evacuate air and/or fluid from the chest cavity or mediastinum.                Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation        Jan-14-2014        Atrium Medical Ocean Water Seal Chest Drain ATS – Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System  with stopcock and in-line connectors; Product Code: 2050-000.To evacuate air and/or fluid from the chest cavity or mediastinum.  Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation        Jan-14-2014        Atrium Medical Express Dry Seal ATS – Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System  Chest Drain; Product Code:  4050-100N.To evacuate air and/or fluid from the chest cavity or mediastinum.      Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation        Jan-14-2014        Atrium Medical Express Dry Seal ATS – Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code:  4050-100P.  To evacuate air and/or fluid from the chest cavity or mediastinum.                Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation        Jan-14-2014        Atrium Medical Ocean Water Seal Chest Drain ATS – Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System  with stopcock and in-line connectors  Sterile fluid path packaging Product Code: 2050-070.To evacuate air and/or fluid from the chest cavity or mediastinum.          Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation        Jan-14-2014        Atrium Medical Ocean Water Seal Chest Drain ATS – Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System  Dual patient lines with stopcock; .Product Code:  2052-300.To evacuate air and/or fluid from the chest cavity or mediastinum.  Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Atrium Medical Corporation        Jan-14-2014        Atrium Medical Ocean Water Seal Chest Drain ATS – Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300.To evacuate air and/or fluid from the chest cavity or mediastinum.  Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Becton Dickinson & Company     Jan-15-2014        BD Interlink threaded lock cannula – BD Interlink threaded lock cannulaThis is a locking blunt plastic cannula specifically designed for IV connection to an Interlink injection site. It is screwed down over the Interlink injection site and a blunt plastic cannula inside the housing enters the Interlink injection site to provide a pathway for IV fluid administration.        BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely impacts unit package integrity and product sterility.

Teleflex Medical               Jan-15-2014        Weck  Electrosurgical Coagulation Suction Tube 8 – Weck; Electrosurgical Coagulation Suction Tube 8 (20.0cm); 11 French; with Stylet; Teleflex Medical; Research Triangle; NC 27709.Intended to remove tissue and control bleeding by use of high-frequency electrical current.              Sterility cannot be guaranteed.

Teleflex Medical               Jan-15-2014        Weck  Electrosurgical Coagulation Suction Tube 6 – Weck; Electrosurgical Coagulation Suction Tube 6 (15.2cm); 11 French; with Stylet; Teleflex Medical; Research Triangle; NC 2770.Intended to remove tissue and control bleeding by use of high-frequency electrical current.              Sterility cannot be guaranteed.

Ge Healthcare It               Jan-15-2014        Imagecast PACS – Imagecast PACS is an image management system intended to be used by trained professionals; including but not limited to physicians; nurses and medical technicians. The system is used with general purpose computing hardware to acquire; transmit; process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image and interpretations. Mammongraphic may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.              In Imagecast PACS versions prior to 3.6.51.01; the estimated magnification factor (0018;1114) was not accounted for. These versions of Imagecast PACS look for values to be present in the following tags to calculate a measurement from pixels to millimeters (mm): (0020;0030) Pixel Spacing and; (0018;1164) Imager Pixel Spacing. Because the estimated magnification factor is not used; distance meas

The Anspach Effort; Inc.                Jan-15-2014        2MM Fluted Ball; 5.6CM – MCA5-2SB – 2MM Fluted Ball; 5.6CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.  The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        1.5MM Diamond Ball; 7.3CM – MCA7-15SD – 1.5MM Diamond Ball; 7.3CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.   The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        Micro Curved Attachment (MCA) Cutting Burr – Micro Curved Attachment (MCA) Cutting Burr; DFU 18-0001.  All lots are included in recall. Part Number MCAIntended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.  The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        2MM Diamond Ball; 7.3CM – MCA7-2SD – 2MM Diamond Ball; 7.3CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.             The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        2MM Diamond Ball; 5.6CM – MCA5-2SD – 2MM Diamond Ball; 5.6CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.             The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        1MM Diamond Ball; 7.3CM – MCA7-1SD – 1MM Diamond Ball; 7.3CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.             The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        0.8MM Diamond Ball; 5.6CM – MCA5-08SD – 0.8MM Diamond Ball; 5.6CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.   The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        0.5 MM Diamond Ball; 5.6CM – MCA5-05SD – 0.5 MM Diamond Ball; 5.6CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.   The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        1.5MM Diamond Ball; 5.6CM – MCA5-15SD – 1.5MM Diamond Ball; 5.6CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.   The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        1MM Diamond Ball; 5.6CM – MCA5-1SD – 1MM Diamond Ball; 5.6CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.             The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        0.7MM Diamond Ball; 5.6CM – MCA5-07SD – 0.7MM Diamond Ball; 5.6CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.   The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        1.5MM Fluted Ball; 5.6CM – MCA5-15SB – 1.5MM Fluted Ball; 5.6CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.             The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        1MM Fluted Ball; 7.3CM – MCA7-1SB – 1MM Fluted Ball; 7.3CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.  The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        0.6MM Diamond Ball; 7.3CM – MCA7-06SD – 0.6MM Diamond Ball; 7.3CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.   The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        0.8MM Diamond Ball; 7.3CM – MCA7-08SD – 0.8MM Diamond Ball; 7.3CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.   The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        0.7MM Diamond Ball; 7.3CM – MCA7-07SD – 0.7MM Diamond Ball; 7.3CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.   The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        1MM Fluted Ball; 5.6CM – MCA5-1SB – 1MM Fluted Ball; 5.6CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.  The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        1.5MM Fluted Ball; 7.3CM – MCA7-15SB – 1.5MM Fluted Ball; 7.3CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.             The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        0.5MM Diamond Ball; 7.3CM – MCA7-05SD – 0.5MM Diamond Ball; 7.3CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.   The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        0.6MM Diamond Ball; 5.6CM – MCA5-06SD – 0.6MM Diamond Ball; 5.6CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.   The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-15-2014        2MM Fluted Ball; 7.3CM – MCA7-2SB – 2MM Fluted Ball; 7.3CM.  All lots are included in recall.Intended for use in cutting and shaping delicate bone material; primarily in otologic procedures such as cochleostomy.  The Anspach Effort; Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools.  The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.  After a labeling correction; Anspach Effort; Inc. decide

The Anspach Effort; Inc.                Jan-16-2014        Anspach MIA 16 – Anspach MIA 16 (16cm Minimally Invasive Attachment); Rx OnlyMIA16 attachments are intended for use with Motor Systems for cutting and shaping bones; including the spine and cranium.      Product did not reach expected sterility assurance level

SpineFrontier; Inc.           Jan-16-2014        Arena-L Trials (Handles and Heads) – Arena-L 38x28Trial Head I 10 Lordotic; Part: 11-81012-08; 11-81012-10; 11-81012-12; 11-81012-14The trial heads are smooth plates that mimic the footprint of the implant; manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties; each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon’s desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure            Handles and heads may not be compatible.

SpineFrontier; Inc.           Jan-16-2014        Arena-L Trials (Handles and Heads) – Arena-L 35×26 Trial Head I 10 Lordotic; Part: 11-81004-08; 11-81004-10; 11-81004-12; 11-81004-14; 11-81004-16The trial heads are smooth plates that mimic the footprint of the implant; manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties; each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon’s desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure.      Handles and heads may not be compatible.

SpineFrontier; Inc.           Jan-16-2014        Arena-L Trials (Handles and Heads) – Arena-L Trial Handle; Part: 11-81002The trial heads are smooth plates that mimic the footprint of the implant; manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties; each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon’s desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure.             Handles and heads may not be compatible.

Lab Vision Corporation  Jan-16-2014        Estrogen Receptor AB-11 (Clone ID5) – Estrogen Receptor AB-11 (Clone ID5)Mouse Monoclonal Antibody1 mk  (2mg.ml) Manufactured by: Lab Vision Corporation; Fremont; CAThermo Fisher ScientificAnatomical PathologyTudor Rd.; Manor ParkRancorn; Cheshire WA7 1TA UKAnalyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed; paraffin embedded tissue sections; to be viewed by light microscopy.        Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.

Siemens Medical Solutions USA;  Inc       Jan-17-2014        SIMVIEW NT and SIMVIEW NT with IDI: – SIMVIEW NT and SIMVIEW NT with IDI:October 01; 2012 Siemens ceased Simview distribution. Manufactured by:Mecaserto now known as MecasimParc de lEsplanade9;Rue Niels Bohr77400 Saint Thibault des Vignes- FranceThe intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy simulation system.              In a very rare occurrence an intended movement of the SimView NT simulation system components could not be stopped with usual hand control or the collision detection functionality.

Siemens Medical Solutions USA;  Inc       Jan-17-2014        550 TxT Treatment Tables which are used in PRIMUS; ONCOR; ARTISTE Linac systems – PRIMUS; ONCOR; ARTISTE Linac systems with component 550 TxT Treatment Table.TT-A; TT-D; TT-M or TT-S Table tops.Manufactured by:SIEMENS AG; MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath;  GERMANY  95478 The intended use of the SIEMENS branded; ARTISTE"; ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 TxT Treatment Table. Combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the TxT"  Treatment Table has been damaged due to contacting a moving part.  The resulting short-circuit cau

Elekta; Inc.          Jan-17-2014        XiO RTP System – XiO RTP SystemThe XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display; both on-screen and in hard-copy; either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.        When the number of fractions is changed for a proton spot beam; the MU are recomputed and rounded if necessary; but the dose is not recalculated as it should be even after saving and re-opening the plan.

Zimmer; Inc.       Jan-17-2014        Zimmer Segmental Systems – Zimmer Segmental Systems; Polyethylene Inserts; Size C.Knee replacement.     After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System; Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.

Zimmer; Inc.       Jan-17-2014        Zimmer Segmental Systems – Zimmer Segmental Systems; Polyethylene Inserts; Size B.Designed to address significant bone loss resulting from oncology; trauma; and/or salvage of previously failed arthroplasty.      After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System; Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.

Becton Dickinson & Co. Jan-17-2014        BD GeneOhm Cdiff Assay – BD GeneOhm Cdiff Assay; Part #441401; containing Lysis Kit sample buffer tubes; 200 tests/kit; labeled as ***GeneOhm Sciences Canada; Inc. 2555 boul. du Parc-Technologique  Quebec; Qc; Canada; G1P 4S5***The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct; qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test; based on real-time PCR; is intended for use as an aid in diagnosis of CDAD.              An incorrect reagent was packed with an in vitro diagnostic kit; which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.

Philips Medical Systems (Cleveland) Inc Jan-17-2014        ADAC ARGU – ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems.  Distributed by Philips Medical Systems; Cleveland; OH             The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (PM) may not detect small cracks or deficiencies in the fork weldment.

Ranir Corporation            Jan-17-2014        UP & UP kids’ power toothbrush – UP & UP kids’ power toothbrush         Ranir; LLC is recalling all lots of UP & UP brand Kid’s Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If thetuft retention disk detaches from the handle; it is a potential choking hazard for children three years old and younger.

Ranir Corporation            Jan-17-2014        TopCare Clifford THE BIG RED DOG power toothbrush – TopCare Clifford THE BIG RED DOG power toothbrush for kids!     Ranir; LLC is recalling all lots of Up & Up brand Kid’s Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If thetuft retention disk detaches from the handle; it is a potential choking hazard for children three years old and younger.

Civco Medical Instruments Inc   Jan-21-2014        Civco Belly Board; REF 126000 – Civco Belly Board MRI; Reusable non-sterile glass fiber belly board with cushion; REF 126000; packaged 1 per box. Product Usage:  This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.         Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.

Civco Medical Instruments Inc   Jan-21-2014        Civco Belly Board; REF 125012 – Civco Belly Board; Reusable non-sterile carbon fiber belly board with cushion; REF 125012; packaged 1 per box. Product Usage:  This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region. Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.

Zeiss; Carl Inc     Jan-21-2014        Compensator Slider Lambda 6×20 component – Compensator Slider Lambda 6×20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager; Axio Scope. A1; Axio Lab. A1).  Component used to determine composition of urinary calculi; urinary sediments; bio-crystallates and diagnosis of pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.          Carl Zeiss Microscopy; LLC has recalled the Compensator Slider Lamda 6×20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate.

Remel Inc            Jan-21-2014        Oxoid Antimicrobial Susceptibility Test Discs; Ampicillin 10 mcg. – Oxoid Antimicrobial Susceptibility Test Discs; Ampicillin 10 mcg.; CT0003B; packaged in cartridges of 50 discs; 5 cartridges/pack. The firm name on the label is Oxoid Ltd.; Basingstoke; Hampshire; England.Used in the semi-quantitative agar diffusion test method for in- vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes     Cartridges may contain individual discs which were not impregnated with antibiotic.

Siemens Healthcare Diagnostics; Inc.      Jan-21-2014        Siemens  ADVIA 1200 and ADVIA 1650 Chemistry Systems – Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems.Automated; clinical chemistry analyzers that can run tests on human serum; plasma; or urine.               An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits; and it is possible for the user to misinterpret or edit the result.

Remel Inc            Jan-21-2014        Oxoid Antimicrobial Susceptibility Test Discs; Ertapenem 10 mcg. – Oxoid Antimicrobial Susceptibility Test Discs; Ertapenem 10 mcg.; CT1761B; packaged in cartridges of 50 discs; 5 cartridges/pack. The firm name on the label is Oxoid Ltd.; Basingstoke; Hampshire; England.Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.    Cartridges may contain individual discs which were not impregnated with antibiotic.

Remel Inc            Jan-21-2014        Oxoid Antimicrobial Susceptibility Test Discs; Norfloxacin 10 mcg – Oxoid Antimicrobial Susceptibility Test Discs; Norfloxacin 10 mcg.; CT0434B; packaged in cartridges of 50 discs; 5 cartridges/pack. The firm name on the label is Oxoid Ltd.; Basingstoke; Hampshire; England.Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.    Cartridges may contain individual discs which were not impregnated with antibiotic.

Remel Inc            Jan-21-2014        Oxoid Antimicrobial Susceptibility Test Discs; Cefpodoxime 10 mcg – Oxoid Antimicrobial Susceptibility Test Discs; Cefpodoxime 10 mcg.; CT1612B; packaged in cartridges of 50 discs; 5 cartridges/pack. The firm name on the label is Oxoid Ltd.; Basingstoke; Hampshire; England.Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes                Cartridges may contain individual discs which were not impregnated with antibiotic.

GE Healthcare; LLC          Jan-21-2014        Precision 500D; Legacy; Prestilix; Monitrol; RFX; SFX; Tilt-C; Prestige VH; Prestige SI; and Prestig – Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems:  Precision 500D; Legacy; Prestilix; Monitrol; RFX; SFX; Tilt-C; Prestige VH; Prestige SI; and Prestige SIIProduct Usage:The systems are intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations on both adult and pediatric subjects. The systmes are used for taking diagnostic radiographic and fluoroscopic exposures of the whole body; skull; spinal column; chest; abdomen; extremities; and other body parts. Applications can be performed with the patient sitting; standing; or lying in the prone or supine position.             GE has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension.  During several Preventive  Maintenance activities it was discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the system.  GE is not aware of any fall of the overhead monitor suspension.

Philips Medical Systems (Cleveland) Inc Jan-21-2014        Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology – Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System; Cleveland; OH.Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes. Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical Laser equals Yes; the Machine Name label and field are covered by the controls above it. The Machine Name cannot be viewed or changed.

Carestream Health; Inc.                Jan-21-2014        Carestream DRX-Evolution with Carestream Health (CSH) Wall Stand (WS) – DRX-Evolution with CSH WSThese products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console; over head tube crane; x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.         Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.

Carestream Health; Inc.                Jan-21-2014        Carestream DRX-Evolution with Full Featured (FF) Wall Stand (WS) – DRX-Evolution with FF WSThese products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console; over head tube crane; x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.                Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.

Carestream Health; Inc.                Jan-21-2014        Kodak DirectView DR 7500 System with motorized Wall Stand (WS) – DR 7500 with FF WSThese products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console; over head tube crane; x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.                Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.

GE Healthcare; LLC          Jan-22-2014        TRAM module – GE Healthcare; TRAM MODULE; High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult; pediatric and neonatal patients during transport from one area of the hospital or facility; and monitoring system; to another. K900540: TRAM modules are intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of TRAM modules is to provide uninterrupted monitoring of physiologic parameter data on adult; pediatric and neonatal patients during transport from one area of the hospital or facility; and monitoring system; to another. The TRAM module functions as a transport monitor during transport; and in the bedside monitor during ICU or OR monitoring. Physiological parameter data includes ECG; invasive blood pressure; non-invasive blood pressure; pulse oximetry; cardiac output; temperature; and respiration. TRAM modules acquire; process and store information regarding these parameters. TRAM modules incorporate different monitoring capabilities based on their configuration. K011000: The TRAM 2001 Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The TRAM 2001 Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult; pediatric; and neonatal patients during transport from one area of the hospital or facility; and monitoring system; to another. During non-transport monitoring; the TRAM 2001 Module functions in the bedside monitoring system. Physiological parameter data includes ECG; invasive blood pressure; non-invasive blood pressure; pulse oximetry; cardiac output; temperature; and respiration. The TRAM 2001 Module acquires; processes and stores information regarding these parameters. The device is intended for use in a professional medical facility; such as hospital; clinic; surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR); post anesthesia recovery (PARR); critical care; surgical intensive care; coronary care; medical intensive care; pediatric intensive care; or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport. K053121: The TRAM Module is intended for use under the direct supervision of a licensed healthcare practitioner; or by personnel trained in its proper use. The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult; pediatric and neonatal patients during transport from one area of the hospital or facility; and monitoring system; to another. During non-transport monitoring; the TRAM Module functions in the bedside monitoring system. Physiological parameter data includes ECG; invasive blood pressure; non-invasive blood pressure; non-invasive blood pressure; pulse oximetry; cardiac output; temperature and respiration. The TRAM Module acquires; processes and stores information regarding these parameters. The device is intended for use in a professional medical facility; such as hospital; clinic; surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR); post anesthesia recovery (PARR); critical care; surgical intensive care; pediatric intensive care; or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport.  GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH; PDM; and/or Tram Module. ECG and Respiration signal noise caused by DASH; PDM; and/or Tram ECG cable connector movement may result in reduced ECG; Respiration and arrhythmia detection performance.

GE Healthcare; LLC          Jan-22-2014        Dash 3000/4000/5000 Patient Monitor – GE Healthcare; Dash 3000; Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult; pediatric and neonatal patients. K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult; pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside; portable; and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department; operating room; post anesthesia recovery; critical care; surgical intensive care; or neonatal intensive care areas located in hospitals; outpatient clinics; free-standing surgical centers; and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram; invasive blood pressure; inoninvasive blood pressure; heart rate; temperature; cardiac output; respiration; pulse oximetry; carbon dioxide; bi-spectral index; impedance cardiography; oxygen; and anesthetic agents as summarized in the operators manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed; trended; stored; and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs. K992929: The Dash 3000 Patient Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult; pediatric and neonatal patients. The Dash is designed as a bedside; portable; and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department; operating room; post anesthesia recovery; critical care; surgical intensive care; pediatric intensive care; or neonatal intensive care areas located in hospitals; outpatient clinics; freestanding surgical centers; and other alternate care facilities; intra-hospital patient transport; inter-hospital patient transport via ground vehicles (i.e. ambulance; etc.) and fixed and rotary winged aircraft; and prehospital emergency response. Physiologic data includes but is not restricted to: electrocardiogram; invasive blood pressure; noninvasive blood pressure; pulse; temperature; cardiac output; respiration; pulse oximetry; and carbon dioxide as summarized in the operators manual. The Dash 3000 Patient Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care. This information can be displayed; trended; stored; and printed.            GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH; PDM; and/or Tram Module. ECG and Respiration signal noise caused by DASH; PDM; and/or Tram ECG cable connector movement may result in reduced ECG; Respiration and arrhythmia detection performance.

GE Healthcare; LLC          Jan-22-2014        Solar 8000 and Transport Pro with Patient Data Module (Marketed as  CARESCAPE Patient Data Module) – SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult; pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. The Solar 8000i with Patient Data Module/Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner; or by personnel trained in proper use of the equipment in a professional medical facility; such as hospital; clinic; surgical center or doctors office. It can be used in multiple areas such as operating room (OR); post anesthesia care unit (PACU); emergency department (ED); chest pain clinic; general intensive care unit (ICU); critical care unit; surgical intensive care unit (SICU); respiratory intensive care unit; coronary care unit (CCU); medical intensive care unit (MICU); pediatric intensive care unit (PICU); or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult; pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG; invasive pressure; non-invasive blood pressure; pulse oximetry; temperature; cardiac output nad respiration. This device acquires; processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module; this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult; pediatric; and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG; invasive pressure; noninvasive blood pressure; pulse oximetry; temperature and respiration. Both the PDM and TRAM acquisition module acquire; process and store information for all aforementioned parameters. The Solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult; pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: Electrocardiogram; invasive pressure; non-invasive blood pressure; pulse; temperature; cardiac output; respiration; pulse oximetry; venous oxygen saturation; transcutaneous pO2 and pCO2; CO2 and respiratory mechanics. The Solar 8000i patient monitoring system is capable of GE Healthcare Page 3 of 6 monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations; O2; impedance cardiography; electroencephalography and bispectral index. The Solar 8000i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and /or analog data outputs. Information from these devices can be displayed; trended and stored in the monitoring system. The solar 8000i patient monitoring system also provides physiological data over the Unity Network.             GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH; PDM; and/or Tram Module. ECG and Respiration signal noise caused by DASH; PDM; and/or Tram ECG cable connector movement may result in reduced ECG; Respiration and arrhythmia detection performance.

Sorin Group Italia S.r.l.   Jan-22-2014        ORCHESTRA/ORCHESTRA PLUS Programmer – ORCHESTRA/ORCHESTRA PLUS Programmer      Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker.

Ziemer Usa Inc  Jan-23-2014        1) FEMTO LDV Z2; 2) FEMTO LDV Z4; 3) FEMTO LDV Z6 – 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK  surgery; tunnel creation for implantation of rings; pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. 3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery; tunnel creation for implantation of rings; pocket creation for implantation of corneal implants; lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.            A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off.

Bard Access Systems      Jan-23-2014        MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. – MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880.Product Usage:The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications; I.V. fluids; parenteral nutrition solutions; blood products; and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performed by percutaneous needle insertion using a non-coring needle. The system consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque silicone catheter. Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device.

Bard Access Systems      Jan-23-2014        Titanium Single Lumen Low-Profile port; with Pre-Attached open-Ended Silicone 6.6Fr Catheter. – Titanium Single Lumen Low-Profile port; with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180Usage:The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications; I.V. fluids; parenteral nutrition solutions; blood products; and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performed by percutaneous needle insertion using a non-coring needle. The system consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque silicone catheter.             Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device.

Davol; Inc.; Subs. C. R. Bard; Inc.                Jan-23-2014        Composix L/P with Echo PS – Composix L/P with Echo PS 6" X 8" Product Code 0144680The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis; with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.             Product labeling does not match product configuration.

Davol; Inc.; Subs. C. R. Bard; Inc.                Jan-23-2014        Composix L/P with Echo PS – Composix L/P with Echo PS 10" X 13" Product Code 0144113The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis; with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.             Product labeling does not match product configuration.

CryoLife; Inc.      Jan-23-2014        CryoPatch SG – Pulmonary Hemi-Artery SGUsed in heart surgery              Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.

Ortho-Clinical Diagnostics             Jan-23-2014        VITROS Chemistry Products COCM Reagent – VITROS Chemistry Products COCM Reagent Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Chemistry Products COCM Reagent due to inaccurate quality control results.

Siemens Healthcare Diagnostics; Inc.      Jan-23-2014        Dimension Vista Cyclosporine Flex reagent cartridge – Dimension Vista Cyclosporine Flex reagent cartridgean in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart; liver; and kidney transplant patients.         Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.

Vital Signs Colorado Inc.                Jan-23-2014        Vital Signs Breathing Circuits – Vital Signs Anesthesia CircuitsThe Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.    Vital Signs Devices (VSD); a GE Healthcare Company; has become aware through a customer complaint of a safety issue associated with a certain Breathing Circuit. A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit as aresult of an internal inspection error and will cause occlusion of gas flow.

Radiometer America Inc               Jan-23-2014        ABL90 FLEX Analyzer Radiometer Medical ApS – ABL90 FLEX Analyzer Radiometer Medical ApS; kandevej 21Brnshj; Denmark A portable; automated analyzer that measures pH; blood gases; electrolytes; glucose; lactate; bilirubin and oximetry in whole blood.       RADIOMETER become aware that if the ABL90 FLEX is tilted; this may potentially cause a negative bias on sodium (Na+) results.

Churchill Medical Systems; Inc.  Jan-23-2014        7 Microbore Trifurcated Extension Set – AMS-530 7 Microbore Trifurcated Extension setsProduct Usage:  Intravascular administration set. Defective component may cause extension sets to leak.

Medrad Mr Inc  Jan-23-2014        Medrad Veris MR Monitors – Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user; responsible to interpret the monitored data made available; will be a professional healthcare provider. Physiological data; gas monitoring; system alarms; and patient analysis will be available to the care provider from the monitor.         The main board; P/N 301641; installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected shutdown of the system while in use; resulting in the loss of vital signs information from the monitor.

Applied Medical Resources Corp               Jan-24-2014        Applied Medical’s Inzii 12/15mm Retrieval System – Applied Medical’s Inzii 12/15mm Retrieval System.Applieds Inzii Tissue Retrieval Bag; Model Number CD004; is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue; organs; and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.    Applied Medical is conducting a voluntary recall of the Inzii 12/15mm retrieval system. During shipment; the retrieval system packaging has the potential to become punctured with small holes; which could compromise the sterile barrier. The likelihood of this situation to occur and result in patient harm is highly unlikely; however; out of an abundance of caution for patient safety and a commitmen

Siemens Medical Solutions USA; Inc.       Jan-24-2014        ACUSON SC2000 Ultrasound System; – ACUSON SC2000 Ultrasound System;Power Input: 100-240VAC; 1600W Max; 50/60 Hz.Manufacturer:Siemens Medical Solutions USA; Inc.685 East Middlefield RoadMountain View; CA 94043SC2000 ultrasound imaging system is intended for Cardiac; neo-natal and fetal cardiac; Pediatric; Transesophageal; Adult Cephalic; Peripheral Vessel; Abdominal; Abdominal interoperative; Intraoperative Neurological; Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes.       The user interface assembly on the ACUSON SC2000  may become loose with the potential for the entire module to fall off of the ultrasound system.

Nellcor Puritan Bennett Inc. (dba Covidien LP)    Jan-24-2014        Puritan Bennett 700 Series Ventilators (PB740 and PB760) – Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients. Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor); PN 4-072214-00 used in the Puritan Bennett" 840; and PN; G-062010-00; used in Puritan Bennett" 740; and760 ventilator systems.  The Operators Manual for PB840 states a nominal life of one year and the Addendum incorrectly states 2 years.

Nellcor Puritan Bennett Inc. (dba Covidien LP)    Jan-24-2014        Puritan Bennett 840 Series Ventilator – Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.       Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor); PN 4-072214-00 used in the Puritan Bennett" 840; and PN; G-062010-00; used in Puritan Bennett" 740; and760 ventilator systems.  The Operators Manual for PB840 states a nominal life of one year and the Addendum incorrectly states 2 years.

Siemens Medical Solutions USA; Inc.       Jan-24-2014        ACUSON SC2000 – ACUSON SC2000Power Input: 100-240VAC; 1600 Max 50/60Hz;Siemens Medical Solutions USA; Inc.685 East Middlefield RoadMountain View; CA 94043Ultrasound imaging system.                The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel; making it unable to steer or control during transport.

Navilyst Medical; Inc.     Jan-24-2014        Port Kit with Access Infusion Set – Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F; Product Number H965450140; Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF; Product Number H965450170; Catalog Number 45-017; 3) 6F/SL/Plastic Port/F; Product Number H965450200; Catalog Number 45-020; 4) 8F/SL/Plastic Port/F; Product Number H965450220; Catalog Number 45-022; 5) 8F/SL/Titanium Ports/F; Product Number H965450250; Catalog Number 45-025; 6) Plastic/6F/non-filled/non-valved; Product Number H965450290; Catalog Number 45-029; 7) Plastic/6F/filled/non-valved; Product Number H965450300; Catalog Number 45-030; 8) Plastic/8F/non-filled/non-valved; Product Number H965450310; Catalog Number 45-031; 9) Plastic/8F/filled/non-valved; Product Number H965450320; Catalog Number 45-032; 10) Plastic/6F/non-filled/valved;  Product Number H965450370; Catalog Number 45-037; 11) Plastic/6F/filled/valved; Product Number H965450380; Catalog Number 45-038; 12) Plastic/8F/non-filled/valved; Product Number H965450390; Catalog Number 45-039; 13) Plastic/8F/filled/valved; Product Number H965450400; Catalog Number 45-040; 14) Titanium/6F/non-filled/valved; Product Number H965450410; Catalog Number 45-041; 15) Titanium/8F/non-filled/valved; Product Number H965450430; Catalog Number 45-043.  Product Usage:  ***K-Shield Port Access Infusion Set; (affected product) supplied by Kawasumi Laboratories. The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion. This device is also indicated for injection of contrast media by a power injector only with power injectable implanted port.***NMI Port is indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids; chemotherapy; analgesics; nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.

Siemens Healthcare Diagnostics; Inc.      Jan-24-2014        Siemens CentraLink" Data Management System V14.0.4; V14.0.5 or V14.0.8 – Siemens CentraLink" Data Management System V14.0.4; V14.0.5 or V14.0.8The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.               Under extremely rare circumstances; a patient result that had been previously disabled may be released without proper review. (Disabled Test in CentraLink System or Aptio System May Become Enabled in CentraLink System.)

Symmetry Medical/SSI  Jan-27-2014        Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container – Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container. Sterilization container systems manufactured and distributed under the following names:SmallSymmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom; REF 50-8731; 270mm x 270mm x 100mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom; REF 50-8732; 270mm x 270mm x 135mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom; REF 50-8733; 270mm x 270mm x 150mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom; REF 50-8734; 270mm x 270mm x 200mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom; REF 50-8735; 270mm x 270mm x 260mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom; REF 50-8744; 270mm x 270mm x 100mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom; REF 50-8745; 270mm x 270mm x 135mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom; REF 50-8746; 270mm x 270mm x 150mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom; REF 50-8747; 270mm x 270mm x 200mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom; REF 50-8748; 270mm x 270mm x 260mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Lid Grey Small 4 Latch; REF 50-8950; 280mm x 276mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Lid Yellow Small 4 Latch; REF 50-8951; 280mm x 276mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Lid Green Small 4 Latch; REF 50-8952; 280mm x 276mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Lid Blue Small 4 Latch; REF 50-8953; 280mm x 276mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Lid Red Small 4 Latch; REF 50-8954; 280mm x 276mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Lid Black Small 4 Latch; REF 50-8955; 280mm x 276mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013MediumSymmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Medium Perforated Bottom; REF 50-8736; 440mm x 270mm x 100mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Medium Perforated Bottom; REF 50-8737; 440mm x 270mm x 135mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive; Antioch; TN  37013Symmetry and CODMAN(R) brands; QUAD-LOCK (TM) Sterilization Container Medium Perforated Bottom; REF 50-8738; 440mm x 270mm x 150mm; QTY:  1; Symmetry Surgical; Inc.; 3034 Owen Drive;                The Quad-Lock(TM) Sterilization Container System may not maintain an effective sterile barrier.

Philips Medical Systems (Cleveland) Inc Jan-27-2014        Brilliance iCT and Brilliance iCT SP – Brilliance iCT and Brilliance iCT SPThese systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment; patient and equipment supports; components and accessories          An artifact that resembles thrombus may appear on the image.

GE Healthcare; LLC          Jan-27-2014        GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems – GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems.  Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.           There is an issue with the Manual Film Composer feature on some CT products.  There is an opportunity; while following a specific workflow; to create a film image with one patient’s images and another patient’s name in the footer.  This is also an issue when within Manual Film Composer; if a color image is selected for printing; another patient’s black and white image appears in the preview screen

Biomerieux France Chemin De L’Or          Jan-27-2014        ZYM B Reagent (REF 70493) – ZYM B Reagent (REF 70493)ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests; which enables group or species identifications of microorganisms.            bioMrieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.

DeRoyal Industries Inc   Jan-27-2014        DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit; w/ Knee/Shoulder Blnkt – DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit; w/ Knee/Shoulder Blnkt NS; REF T653NS; Rx only; Manufacturer  DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN  37849.Physical Therapy.   The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.

DeRoyal Industries Inc   Jan-27-2014        DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit; w/ Knee/Shoulder Blanket – DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit; w/ Knee/Shoulder Blanket NS; REF T652NS; Rx only; Manufacturer  DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN  37849.Physical Therapy.   The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.

DeRoyal Industries Inc   Jan-27-2014        DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit; w/ Foot/Ankle Blanket – DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit; w/ Foot/Ankle Blanket NS; REF T656NS; Rx only; Manufacturer  DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN  37849.Physical Therapy.   The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.

Biomerieux France Chemin De L’Or          Jan-27-2014        API Listeria (REF 10300)) – API Listeria (REF 10300)API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests; as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.           bioMrieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.

DeRoyal Industries Inc   Jan-27-2014        DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit; w/ Knee Blanket w/ Straps – DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit; w/ Knee Blanket w/ Straps NS; REF T654NS; Rx only; Manufacturer  DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN  37849.Physical Therapy.   The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.

DeRoyal Industries Inc   Jan-27-2014        Aquarius (TM) TEMPERATURE THERAPY – Aquarius (TM) TEMPERATURE THERAPY; REF T650; Rx Only; Manufactured for DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN  37849; Made in China.Physical Therapy.              The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.

Biomerieux France Chemin De L’Or          Jan-27-2014        API NH (REF 10400) – API NH (REF 10400)API NH is a standardized system for the identification of Neisseria; Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis); which uses miniaturized tests; as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae; as well as the detection of a penicllinase.       bioMrieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.

DeRoyal Industries Inc   Jan-27-2014        DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit; w/ Shoulder Blanket w/ Straps – DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit; w/ Shoulder Blanket w/ Straps NS; REF T655NS; Rx only; Manufacturer  DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN  37849.Physical Therapy.     The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.

Philips Healthcare            Jan-27-2014        Thermal Regulating System – InnerCool RTx Endovascular System; Model Numbers: 861470 (120V); 861472 (240V).Product Usage:The InnerCool RTx device is a thermal regulating system intended to induce; maintain and reverse mild hypothermia; to achieve and/or maintain normothermia; and for use in fever reduction.K080908                Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.

Philips Medical Systems (Cleveland) Inc Jan-27-2014        Brilliance iCT and iCT SP – Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems; Philips Healthcare; Cleveland; OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment; patient and equipment supports; components and accessories.                Patient images exhibited ring artifacts.

Carestream Health; Inc.                Jan-27-2014        KODAK DirectView DR 7500 Dual Detector System; MODEL DR 7500 – KODAK DirectView DR 7500 Dual Detector System; MODEL DR 7500; Manufactured by Carestream Health; Inc. 150 Verona Street Rochester; NY 14608.  Made in U.S.A.     Carestream Health; Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.

Accuray Incorporated    Jan-27-2014        Accuray CyberKnife Robotic Radiosurgery System – Accuray CyberKnife Robotic Radiosurgery System; Accuray IncorporatedSunnyvale; CA.Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.              Potential Safety issue with Synchrony Boom Arm Mounting Assembly – one complaint of mounting assembly detaching.

The Anspach Effort; Inc.                Jan-27-2014        Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. – Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw.  Rx onlySingle use Sterile bone cutting burs.              Cutter was longer that was stated on the label

The Anspach Effort; Inc.                Jan-27-2014        AnspacSingle use Sterile bone cutting burs – AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.      Cutter was longer that was stated on the label

GE Healthcare; LLC          Jan-28-2014        IGS 630 – GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System.Product Usage:  The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular; vascular and non-vascular; diagnostic and interventional procedures. Additionally; with the OR table; the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. The Cathiab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution. The Cathiab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing: 1) Communication protocols for exchanging and automatically synchronizing patient; exam; system; and image information between the angiographic X-ray systems and the imaging / data medical devices. 2) Communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface. 3) Interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems. GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems.While performing fluoroscopy on a biplane fluoroscopy unit; there is a potential for loss of the x-ray imaging function when the user changes the size of the lateral FOV (Field of View) and releases the biplane footswitch pedal simultaneously. This could lead to a system lock up requiring

GE Healthcare; LLC          Jan-28-2014        GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. – GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850.The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult; pediatric; and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of; and to generate alarms for; hemodynamic (including ECG; ST segment; arrhythmia detection; ECG diagnostic analysis and measurement; invasive pressure; non-invasive blood pressure; pulse oximetry; cardiac output; temperature and mixed venous oxygen saturation); impedance respiration; airway gases (CO2; O2; N2O and anesthetic agents); spirometry; gas exchange; and neurophysiological (including electroencephalography; Entropy; Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner; or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult; pediatric; and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG; ST Segment; Arrhythmia Detection; ECG Diagnostic Analysis and Measurement; Invasive Pressure; Noninvasive Blood Pressure; Pulse Oximetry; Cardiac Output; Temperature; Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation); Airway Gases (Fi/Et C02; 02; N20 and Anesthetic Agent); Spirometry; Gas Exchange (02 Consumption (VO2); C02 production (VCO2); energy expenditure (BE); and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG); Entropy; Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms; trends; snapshots and events; and calculations and can be connected to displays; printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner; or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner; the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.             GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These included 25 issues related to  NIBP (Non-InvasiVentilation Alarms:ve Blood Pressure) ; ECG; Central Monitor; General; Tram; and  Bed to Bed Issues.

Siemens Healthcare Diagnostics; Inc.      Jan-28-2014        Siemens User Defined Method Flex Assignment/Dimension Vista 500 Dimension Vista 1500 System – User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lowerUser Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting; mixing; heating; and measuring spectral intensities to determine a variety of analytes in human body fluids.                When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system; and then use the incorrect Flex Cartridge to process the user defined method.

ACUTE Innovations; LLC                Jan-28-2014        ACUTE Innovations Ribloc U plus Rib Fracture Plating System – The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures; fusions and osteotomies during the normal bone healing process.  The plates are manufactured from titanium and the screws are manufactured from titanium alloy.  Surgical instrumentation is supplied with the implants in a surgical tray to facilitate the proper insertion of the plates and screws.The ACUTE Innovations Modular RibLoc System is intended to stabilize and provide fixation for fractures; fusions; and osteotomies of the ribs; and for reconstructions of the chest wall and sternum.Part Numbers:RBL1301- 50 mm Rib Plate; RBL1302- 75 mm Rib Plate; RBL1303- 115 mm Rib Plate;RBL1304- 155 mm Rib Plate; RBL1305- 215 mm Rib Plate;            The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery.

Maquet Cardiovascular Us Sales; Llc        Jan-28-2014        Maquet Compressor Mini – Compressor MiniTo provide a supply of dry; filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers; physicians; nurses; and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.             Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.

Zimmer Dental Inc           Jan-28-2014        Tapered Screw-Vent Implant; MTX; 4.7mm x 11.5mm; 4.5mm Platform – Tapered Screw-Vent Implant; MTX; 4.7mm x 11.5mm; 4.5mm Platform. Catalog Number TSVWB11; Lot 62470008.Class II; 510(k) K13227.                Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant; Catalog TSVWB11; Lot 62470008; because some of the packages of this lot may have the Cap Label state 3.7 x 10mm instead of 4.7 x 11.5mm.

Kimberly-Clark Corporation         Jan-28-2014        Kimberly-Clark RadiOpaque Radiofrequency Cannula – Kimberly-Clark RadiOpaque Radiofrequency Cannula; Gauge 22; Length 100 mm; Active Tip 10 mm; Distributed in the US by Kimberly-Clark;Product code PMF22-100-10The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes.       Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.

Orthofix; Inc.     Jan-28-2014        Orthofix – Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver; Product Usage:  The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.  Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the  Modular Screw Driver (PN 52-1332).  The complaints alleged that the screw driver’s collet would malfunction resulting in the surgeon being unable to use the Modular Screw Driver to effectively place Modular Screws; which may result in a delay of surgery.

Focus Diagnostics Inc      Jan-28-2014        Simplexa" Flu A/B & RSV Direct assay – Simplexa" Flu A/B & RSV Direct assay; Model MOL2650.The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus; influenza B virus; and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A; influenza B; and RSV viral infections in humans and is not intended to detect influenza C.            Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals; which may result in a higher RSV false positive rate.

Stryker Howmedica Osteonics Corp.       Jan-28-2014        Stryker Howmedica Osteonics – Teflon Tube; sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-524232 Sconkidrchen; Germanydistributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah; NJ 07430 USA510 K042396Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems; T2 Femoral Nailing Systems; T2 Ankle Nailing Systems; and T2 Humerus Nailing Systems                Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for certain lots of the product Teflon Tube; sterile.

Sorin Group Deutschland GmbH               Jan-28-2014        CP5 centrifugal pump system – CP5 centrifugal pump systemProduct Usage:The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.  Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.

Sorin Group Deutschland GmbH               Jan-28-2014        Stockert S5 System I Sorin C5 System – S5/C5 Heart-lung machineProduct Usage:  The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.  Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.

Carestream Health Inc.  Jan-29-2014        Carestream DRX Evolution System (Standard Q) – Carestream DRX Evolution System (Standard Q)The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console; over head tube crane; x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstandbucky to complete x-ray exposures.         Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system allowed an exposure without the assignment of a bucky or image receptor.

Philips Medical Systems (Cleveland) Inc Jan-29-2014        Philips Brilliance CT system – Brilliance iCT; Brilliance 64 and Brilliance Big BoreThe Brilliance iCT; Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories.    The DoseRight feature suggest a mAs based on the measured patient size; a reference size and a reference mAs.  When scanning large children; the suggested mAs may be higher than clinicians would expect.

Codman & Shurtleff; Inc.              Jan-29-2014        CODMAN CERTAS Programmable Valve – Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and AccessoriesProduct Code: 82-8803Product Usage:The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.         Codman Certas Programmable Valves used for hydrocephalus may not operate properly

Codman & Shurtleff; Inc.              Jan-29-2014        CODMAN CERTAS Programmable Valve – Codman Certas Programmable Valve In Line Valve with Siphonguard; Unitized Catheter and AccessoriesProduct Code: 82-8806Product Usage:The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.               Codman Certas Programmable Valves used for hydrocephalus may not operate properly

Codman & Shurtleff; Inc.              Jan-29-2014        CODMAN CERTAS Programmable Valve – Codman Certas Programmable Valve In Line Valve with Catheter and AccessoriesProduct Code: 82-8801Product Usage:The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.         Codman Certas Programmable Valves used for hydrocephalus may not operate properly

Codman & Shurtleff; Inc.              Jan-29-2014        CODMAN CERTAS Programmable Valve – Codman Certas Programmable Valve In Line Valve only with SiphonGuard DeviceProduct Code: 82-8804Product Usage:The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.         Codman Certas Programmable Valves used for hydrocephalus may not operate properly

Codman & Shurtleff; Inc.              Jan-29-2014        CODMAN CERTAS Programmable Valve – Codman Certas Programmable Valve In Line Valve with SiphonGuard Device; Unitized Bactiseal Catheter and AccessoriesProduct Code: 82-8807Product Usage:The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.               Codman Certas Programmable Valves used for hydrocephalus may not operate properly

Codman & Shurtleff; Inc.              Jan-29-2014        "CODMAN CERTAS Programmable Valve – Codman Certas Programmable Valve In Line Valve OnlyProduct Code: 82-8800  Product Usage:The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting."      Codman Certas Programmable Valves used for hydrocephalus may not operate properly

Codman & Shurtleff; Inc.              Jan-29-2014        CODMAN CERTAS Programmable Valve – Codman Certas Programmable Valve In Line Valve with SiphonGuard Device; Catheter and AccessoriesProduct Code: 82-8805Product Usage:The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.         Codman Certas Programmable Valves used for hydrocephalus may not operate properly

Siemens Healthcare Diagnostics                Jan-30-2014        IMMULITE 2000 Systems T3F (Free T3) – T3F; Free T3 Assay; REF/Catalog Number L2KF32 (200 tests); Siemens Material Number (SMN) 10381675; and REF/Catalog Number L2KF36 (600 Tests); SMN 10381682; an IVD Immunoassay kit for use with the IMMULITE 2000/IMMULITE 200 XPi Analyzers — Origin: UK  Siemens Healthcare Diagnostics Products Ltd. Llanberis; Gwynedd; LL55 4EL UK.For the quantitative measurement of Free T3 in serum; as an aid in the clinical assessment of thyroid status.              Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the Instructions For Use for the IMMULITE/IMMULITE 1000 and/or IMMULITE 2000/IMMULITE 2000 XPi for several lots of Free T3 kits.  A positive bias in quality control

Siemens Healthcare Diagnostics                Jan-30-2014        IMMULITE /IMMULITE 1000 Systems T3F (Free T3) – T3F; Free T3 Assay; REF/Catalog Number LKF31; Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers — Shipping or unit package: 100; 200; 500 and 600 test kits  — Origin: UK  Siemens Healthcare Diagnostics Products Ltd. Llanberis; Gwynedd; LL55 4EL UK.For the quantitative measurement of Free T3 in serum; as an aid in the clinical assessment of thyroid status.        Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the Instructions For Use for the IMMULITE/IMMULITE 1000 and/or IMMULITE 2000/IMMULITE 2000 XPi for several lots of Free T3 kits.  A positive bias in quality control

Merit Medical Systems; Inc.        Jan-30-2014        Merit RAD BOARD – Radial Assist RAD BOARD; used to support theweight of a patient’s arm and supplies for a medical procedure.The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patient’s arm and supplies for medical procedure; in order to have optimal access to upper extremity vasculature; including radial and brachial arterial and venous access. The RAD BOARD is partially lined with a layer of lead-free Xenolite TB for additional radiation scatter protection.         Merit Medical Systems; Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 devices. The affected devices are missing the main label which graphically depicts patient orientation on the board. The issue may allow the board to be oriented in the wrong direction where the semi-radiopaque material in the board (embedded Xenolite) could obscure patient anatomy during fluoroscopy. There

Medtronic Sofamor Danek USA Inc          Jan-30-2014        SET SCREW RETAINING DRIVER – SET SCREW RETAINING DRIVER; REF 3010000820; QTY: 1 EA; Medtronic Sofamor Danek; USA; Inc.; 1800 Pyramid Place; Memphis; TN  38132.Screwdriver – orthopedic manual surgical instrument. The retaining tabs component of the Set Screw Retaining Drive may be oversized; which will not allow proper mating between the Set Screw Retaining Drive and the set screw.

Becton Dickinson & Co. Jan-30-2014        BD BACTEC FX 40 instrument – BD BACTEC FX 40 instrument; catalog number 442296; manufactured by BD Diagnostic Systems; 7 Loveton Circle; Sparks; MD 21152.The instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials; which are placed into the instrument for incubation and testing.     Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.

Becton Dickinson & Co. Jan-30-2014        BD BACTEC FX- Top Unit instrument – BD BACTEC FX- Top Unit instrument; catalog number 441385; and Bottom Unit instrument; catalog 441386; available as a single or a stack configuration; Manufactured by BD Diagnostic Systems; 7 Loveton Circle; Sparks; MD 21152.The BD BACTEC FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials; which are placed into the instrument for incubation and testing.     Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.

Synergetics Inc  Jan-30-2014        25ga Awh Chandelier; Synergetics; inc. – 25ga Awh Chandelier; Synergetics; inc.; length 8.0 ft; sterile / EO; 56.50.25P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.     Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        Wide Field Endo Illuminator; Vivid ™ Endo Illuminator; 20ga; Synergetics; inc. – Wide Field Endo Illuminator; Vivid ™ Endo Illuminator; 20ga; Synergetics; inc.; 20ga; length 7.5 ft; sterile / EO; 56.21P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.          Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        23ga Wide Field Corona Endo Illuminator; Synergetics; inc.; – 23ga Wide Field Corona Endo Illuminator; Synergetics; inc.; length 7.5 ft; sterile / EO; 56.12.23P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.           Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        The Corona Shielded Wide Field Endo Illuminator; Synergetics; inc. – "The Corona" Shielded Wide Field Endo Illuminator; Synergetics; inc. 20ga; length 7.0 ft; sterile / EO; 56.12. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.          Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        23ga Wide Field Endo Illuminator; Synergetics; inc. – 23ga Wide Field Endo Illuminator; Synergetics; inc.; length 7.5 ft; sterile / EO; 56.21.23P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.       Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        23ga Endo Illuminator (Eckardt Trocar Compatible); Synergetics; inc. – 23ga Endo Illuminator (Eckardt Trocar Compatible); Synergetics; inc.; length 8.0 ft; sterile / EO; 56.02.23P Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.          Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        23ga Straight Fixed Extended Illuminated Laser Probe; Synergetics – 23ga Straight Fixed Extended Illuminated Laser Probe; Synergetics; length 7.5 ft; sterile / EO; 55.62.23P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.          Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        Two-Port Vitrectomy (TPV ™) Wide Field High Flow End Irrigator; Synergetics; inc. – Two-Port Vitrectomy (TPV ™) Wide Field High Flow End Irrigator; Synergetics; inc.; 19ga; length 7.0 ft; sterile / EO; 56.14. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.         Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        Standard tubing set; Synergetics; Inc. – Standard tubing set; Synergetics; Inc.; length 10 ft; sterile / EO; 17570. Packed 6 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.     Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        25ga Aspirating Endo Illuminator; Synergetics – 25ga Aspirating Endo Illuminator; Synergetics; length 7.5 ft; sterile / EO; 56.24.25P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.                Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        Stiff 25ga Chow Illuminated Pick (Dull); Synergetics; inc. – Stiff 25ga Chow Illuminated Pick (Dull); Synergetics; inc.;  length 8.0 ft; sterile / EO; 56.07.25PS. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.    Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        23ga Mid-Field Endo Illuminator; Synergetics – 23ga Mid-Field Endo Illuminator; Synergetics length 7.5 ft; sterile / EO; 56.22.23P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.                Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        Chandelier Infusion Cannula; Synergetics; inc. – Chandelier Infusion Cannula; Synergetics; inc.; 20ga; length 7.5 ft; sterile / EO; 56.30.P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.                Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        Vivid ™ Endo Illuminator; 20ga; Synergetics; inc. – Vivid ™ Endo Illuminator; 20ga; Synergetics; inc.; length 7.5 ft; sterile / EO; 56.20P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.       Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        Stiff 25ga Wide Field Endo Illuminator; Synergetics; inc. – Stiff 25ga Wide Field Endo Illuminator; Synergetics; inc. length 7.5 ft; sterile / EO; 56.21.25PS. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.           Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        25ga Endo Illuminator; Synergetics; inc. – 25ga Endo Illuminator; Synergetics; inc.; length 7.0 ft; sterile / EO; 56.02.25 Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.         Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        27ga ONE-STEP ™ Awh/Tano Vivid Chandelier; Synergetics – 27ga ONE-STEP ™ Awh/Tano Vivid Chandelier; Synergetics; length 8.0 ft; sterile / EO; 56.55.27P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO. Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        25ga Awh Vivid Chandelier; Synergetics – 25ga Awh Vivid Chandelier; Synergetics; length 7.5 ft; sterile / EO; 56.54.25P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.     Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        23ga Chandelier Infusion Cannula; Synergetics; inc. – 23ga Chandelier Infusion Cannula; Synergetics; inc.; length 8.0 ft; sterile / EO; 56.30.23P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.       Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        23ga Chow Illuminated Pick; Synergetics; inc. – 23ga Chow Illuminated Pick; Synergetics; inc.; length 7.5 ft; sterile / EO; 56.07.23P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.                Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        25ga Wide Field Corona Endo Illuminator; Synergetics; inc. – 25ga Wide Field Corona Endo Illuminator; Synergetics; inc.; length 7.5 ft; sterile / EO; 56.12.23P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.           Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Spacelabs Healthcare; Llc              Jan-30-2014        ARIATELE TELEMETRY TRANSMITTER; Model 96281 – ARIATELE TELEMETRY TRANSMITTER; Model 96281; with SpO2 Option C.Model 96281 is intended for use with either adult or neonatal patientpopulations in a hospital environment.   The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmitter) display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions.

Synergetics Inc  Jan-30-2014        27ga ONE-STEP ™ Endo Illuminator; Synergetics; inc. – 27ga ONE-STEP ™ Endo Illuminator; Synergetics; inc.;  length 7.5 ft; sterile / EO; 56.02.27P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.           Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        29ga Oshima Dual Chandelier; Synergetics; inc. – 29ga Oshima Dual Chandelier; Synergetics; inc.; length 7.5 ft; sterile / EO; 56.50.29P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.                Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        25ga Mid-Field Endo Illuminator; Synergetics – 25ga Mid-Field Endo Illuminator; Synergetics; length 7.5 ft; sterile / EO; 56.22.25P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.                Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        Endo Illuminator; Synergetics; inc. – Endo Illuminator; Synergetics; inc.; 20ga; length 7.0 ft; sterile / EO; 56.02. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.    Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        23ga Aspirating Endo Illuminator; Synergetics – 23ga Aspirating Endo Illuminator; Synergetics; length 7.5 ft; sterile / EO; 56.24.23P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.                Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        25ga Awh Chandelier; Synergetics; inc. – 25ga Awh Chandelier; Synergetics; inc.; B&L Cannula Compatible; length 8.0 ft; sterile / EO; 56.52.25P. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.    Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

Synergetics Inc  Jan-30-2014        Stiff 25ga Endo Illuminator; Synergetics; inc. – Stiff 25ga Endo Illuminator; Synergetics; inc.; length 7.5 ft; sterile / EO; 56.02.25PS. Packed 12 units per box. Manufactured for Synergetics; Inc.; O’Fallon; MO.                Faulty seals on the outer pouch of various; double-pouched; single-use; sterile; ophthalmic devices could result in seal failure.

2x4mm Ptfe Tube Flexible Tube

Boston Scientific Corporation     Jan-30-2014        Atlantis PV 15 MHz Peripheral Imaging Catheter – Atlantis PV; 8.5F;  15 MHz Peripheral Imaging Catheter:Sterile; R; Sterilized using irradiation.Product Usage:This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire. Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.

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