Medical device recalls for December 2012

Class I recalls

Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall

Verathon; Inc.   Dec-07-2012       The GlideScope Video Laryngoscope (GVL)- GVL 3; GVL4; GVL5 – The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera; an LED light source; a rechargeable lithium battery; and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor.The affected GVL and Part numbers are GVL 3  0574-0007; GVL 4  0574-0001; and GVL 5  0574-0030.The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear; unobstructed view of the vocal cords for medical procedures.                Re-usable video laryngoscope blades of the GlideScope GVL3; GVL4; and GVL5 were recalled due to potential cracking.

Medtronic Neuromodulation     Dec-13-2012       SynchroMed EL implantable infusion pump – SynchroMed EL; models 8626-10; 8626L-10; 8626-18; 8626L-18; 8627-10; 8627L-10; 8627-18; 8627L-18.  implantable infusion pump.  The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter.  The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller; lower profile pump when presented with the choice; when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.                Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system.  Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion.

Medtronic Neuromodulation     Dec-13-2012       SynchroMed II implantable infusion pump – Medtronic SynchroMed II; Model 8637; (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump; catheter; and catheter accessories.     Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system.  Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion.

Bunnell; Inc.       Dec-14-2012       Life Pulse High Frequency Ventilator – Patient Circuit used with the Life Pulse High Frequency Ventilator.  The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator.Model #(s):Individual Patient Circuit – catalog # 902Patient Circuit Kit – catalog # 937: contains 2 circuits and 2 x 2.5 & 2 x 3.5 LifePort Adapters.Labeling states manufactured by: Bunnell Incorporated 436 Lawndale Drive; Salt Lake City; Utah 84115.Used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks; who are; in the opinion of their physicians; failing on conventional ventilation. The Patient Circuit is to provide a conduit for the humidification; warming; and temperature monitoring of the pressurized gas. The Patient Circuit is indicated for seven day single use.               Customer complaints received indicate the heater wire insulation can melt; causing a short which creates sparking and smoke; in the circuit close to the humidifier cartridge.  Bunnell is recalling all lots of circuits distributed between March 12; 2012 and November 30; 2012.

Praxair Inc.          Dec-21-2012       Praxair Vantage Grab n Go – Praxair Vantage Grab n Go – Gas Cylinder pressure regulatorCatalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.                Isolated incidents of ignition inside Grab n’ Go cylinders that had been knocked over or otherwise subject to significant physical impact.

Zimmer; Inc.       Dec-22-2012       Ardis Interbody System Inserter – Ardis Interbody System InserterThe Ardis Inserter is intended for delivery of the Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the gold and silver knobs of the inserter to thread the shaft securely to the implant. Once the implant is inserted into the disc space and its position confirmed radiographically; the inserter is removed from the implant by turning the knobs counterclockwise to loosen and unthread the shaft from the implant.       The Ardis System implant may break when excessive lateral forces are applied to the implant during insertion using the Ardis Inserter. Zimmer Spine has received complaint reports at a 0.47% occurrence rate associated with this issue (data from a 54 month monitoring period).

GE Healthcare; LLC          Dec-26-2012       Giraffe and Panda Warmer T-Piece Resuscitation System – GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit; QTY: 10; M1091316 T-Piece Disposable Circuit Kit with Mask  Size O;  M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask; Size 1; Lot 1981713 *** Ohmeda Medical; A Division of Datex-Ohmeda; Inc. A General Electric Company Laurel; MD 20723 USA MADE IN USA***Provides the basic equipment required for pulmonary resuscitation of infants.                Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.

Class II recalls

Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall

Siemens Healthcare Diagnostics; Inc.      Dec-03-2012       Siemens Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) – Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085)The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.                Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources.  All lots of IRON Flex(R) reagent cartridges have the potential for this issue.  If a well set is contaminated with trace amounts of iron; the entire well set is impacted; and the mag

OmniGuide; Inc.               Dec-03-2012       OmniGuide BP-ROBOTIC – OmniGuide BP-ROBOTIC ( BeamPath Robotic); Single UseCat. # BP-ROBOTICThe OmniGuide Fiber is indicated for the incision; excision; ablation; vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery; oral/maxillofacial surgery; dentistry; dermatology; gynecology; otorhinolaryngology; gastroenterology; neurosurgery; urology; and pulmonology; and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes; such as in laryngoscopy; gastroscopy; colonoscopy; laparoscopy; thoracoscopy; hysteroscopy and bronchoscopy      Failure of glue joint; allowed a portion of the single use device to shift inside; may separate and fall into the patient

Siemens Medical Solutions USA; Inc        Dec-03-2012       Siemens syngo.plaza Radiological Image Processing System – Siemens syngo.plaza Radiological Image Processing SystemUsage: Radiological Image Processing System              Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction.  The Update Instruction SY050/12/S provides a software update and addresses the following issues:  – Patient Rename messages for the same patient are being continually processed for several days.  This fills up the ‘pcvdbsrv’ log and potentially affects performance of the system.  – Data could

Terumo Cardiovascular Systems Corporation      Dec-03-2012       Sarns Soft Flow Aortic Cannulae – 24 Fr 8mm Sft Flow StraightThe Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.     Based on a review retrospective review of quality data; the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect; it was determined that the product does not meet specif

Terumo Cardiovascular Systems Corporation      Dec-03-2012       Sarns Soft Flow Aortic Cannulae – 18 Fr 6mm Sft Flow Ang Wire W/LThe Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.     Based on a review retrospective review of quality data; the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect; it was determined that the product does not meet specif

Sekisui Diagnostics Llc    Dec-03-2012       Sekisui Diagnostics; Spectrolyse PAI-1 catalog # 101201 – Sekisui Diagnostics; Spectrolyse PAI-1 In-Vitro Diagnostic Use  for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma.Catalog # 101201.Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.  Spectrolyse PAI-1 activity assay; producing lower than expected absorbance values with "0" standard reducing  the slope of the standard curve requiring more frequent sample dilutions.

Terumo Cardiovascular Systems Corporation      Dec-03-2012       Sarns Soft Flow Aortic Cannulae – 18 Fr 6mm Sft Flow Angled WireThe Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.     Based on a review retrospective review of quality data; the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect; it was determined that the product does not meet specif

Terumo Cardiovascular Systems Corporation      Dec-03-2012       Sarns Soft Flow Aortic Cannulae – 24 Fr 8mm Sft Flow Straight WirThe Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use       Based on a review retrospective review of quality data; the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect; it was determined that the product does not meet specif

Terumo Cardiovascular Systems Corporation      Dec-03-2012       Sarns Soft Flow Aortic Cannulae – 24 Fr 8mm Soft Flow Ang Wire W/LThe Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.     Based on a review retrospective review of quality data; the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect; it was determined that the product does not meet specif

Terumo Cardiovascular Systems Corporation      Dec-03-2012       Sarns Soft Flow Aortic Cannulae – 24 Fr 8mm Sft Flow Str Wire W/LThe Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.     Based on a review retrospective review of quality data; the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect; it was determined that the product does not meet specif

Terumo Cardiovascular Systems Corporation      Dec-03-2012       Sarns Soft Flow Aortic Cannulae – 24 Fr 8mm Soft Flow Ang W/LThe Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.     Based on a review retrospective review of quality data; the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect; it was determined that the product does not meet specif

Merit Medical Systems; Inc.        Dec-03-2012       Custom Procedural Trays – Custom Procedural Trays: Merit’s Custom Total Hip Pack; K12T-05537; Merit’s Total Knee Pack; K12T05538A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product’s intended uses.  Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear tape that is intended to aid in the prevention of patient’s fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga; was not applied during the manufacturing process.

Stryker Instruments Div. of Stryker Corporation                Dec-03-2012       Neptune 2 Rover -Ultra – Neptune¿ 2 Rover – ULTRA ~120V ~ 60 Hz 12AREF 0702-001-000; Rx; Caution; consult accompanying documentsConsult instructions for use; Max Vacuum; 21.0 in-Hg; 530 mm-Hg; The Neptune Waste Management System consists of a mobile rover unitused to suction and collect fluid waste; small debris and electrocauterysmoke from a surgical site. Mobility allows the rover unit to berelocated to a waste disposal area where the rovers collection canisterscan be emptied; via the docking station.Intended to be used in the Operating Room; Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.              Beginning May 24; 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover’s ability to roll. This can result in additional strain on the operator; due to multiple exposures resulting in back pain.

Stryker Instruments Div. of Stryker Corporation                Dec-03-2012       Neptune 2 Rover -Ultra – Neptune¿ 2 Rover – ULTRA ~230V ~ 50 Hz 12AREF 0702-002-000; Rx Caution; consult accompanying documentsConsult instructions for use; Max Vacuum; 21.0 in-Hg; 530 mm-Hg; The Neptune Waste Management System consists of a mobile rover unitused to suction and collect fluid waste; small debris and electrocauterysmoke from a surgical site. Mobility allows the rover unit to berelocated to a waste disposal area where the rovers collection canisterscan be emptied; via the docking station.Intended to be used in the Operating Room; Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.              Beginning May 24; 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover’s ability to roll. This can result in additional strain on the operator; due to multiple exposures resulting in back pain.

Roche Diagnostics Operations; Inc.          Dec-04-2012       Cobas 8000 Modular Analyzer Series – Cobas 8000 Modular Analyzer Series; Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.               On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer; a mismatch between the reagent probe positioning and the aspirated reagent volumes under certain conditions can lead to insufficient reagent pipetting.  This may affect patient sample and controls recovery for the following tests: Alkaline Phosphatase (ALP2); Alanine Aminotransferase (ALT); Bicarbonate (CO2-L); Creatinine (C

Philips And Neusoft Medical Systems Co.; Ltd.   Dec-04-2012       NeuViz 16 Multi-Sliced CT Scanner System and NeuViz Dual series CT Scanner System – NeuViz 16 Multi-Sliced CT Scanner System; part number 989605858501.  NeuViz Dual series CT Scanner System; part number 989605651321The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.    The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach.  This issue may affect NeuViz Dual and NeuViz 16 scanners.

Invivo Corporation          Dec-04-2012       Invivo Corporation Expression MRI Patient Monitoring System – Invivo Corporation Expression MRI Patient Monitoring System.The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.       Invivo Corporation located at 12151 Research Parkway; Orlando; FL 32826 is recalling the Expression MRI Patient Monitoring System because during transport of the systems cart with a docked Display Controller Unit (DCU); a caster (wheel) may become detached.  If this occurs; the cart can become unbalanced and may fall.

iwalk inc               Dec-04-2012       BiOMBiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium – BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system:Product Number: 2001249 BiOM BatteryProduct Number: 2001240 BiOM Charger Battery may over-heat during charging and smoke

Biomet; Inc.        Dec-04-2012       OSS Reamer Sleeve – OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEELThe OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.       Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.

Biomet; Inc.        Dec-04-2012       OSS Reamer Sleeve – OSS Reamer Sleeve REF132-472662   KNEE REAMER SLEEVE 13.0 thru 20.0  STAINLESS STEELThe OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.       Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.

Stryker Howmedica Osteonics Corp.       Dec-04-2012       Stryker Howmedica Osteonics Corp. – Stryker OrthopaedicsFEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTSREF 6543-1-600;NON-STERILEHowmedica Osteonics Corp.325 Corporate DriveMahwah; NJ  07430  USAA Subsidiary of Stryker Corp.Stryker FranceZAC Satolas Green PusignanAv de Satolas Green 69881 MeyzieuCedex FranceThe Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor; which allows for optimal bone coverage; compensating for differences between the Implant and bone canal axes. Made in USA       Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not include rotational markings.

Stryker Howmedica Osteonics Corp.       Dec-04-2012       Stryker Howmedica Osteonics Corp. – Stryker OrthopaedicsTIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTSREF 6543-2-600;NON-STERILE Howmedica Osteonics Corp.325 Corporate DriveMahwah; NJ  07430  USAA Subsidiary of Stryker Corp.Stryker FranceZAC Satolas Green PusignanAv de Satolas Green 69881 MeyzieuCedex FranceMade in USAThe Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor; which allows for optimal bone coverage; compensating for differences between the Implant and bone canal axes.                Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not include rotational markings.

Biomet; Inc.        Dec-05-2012       OSS Knee Reamer Sleeves – Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant)Product Usage:The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.   The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching; which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.

Philips Healthcare Inc.    Dec-05-2012       Philips Digital Diagnost R2.0.2 – Philips Digital Diagnost Software Version R2.0.2Product Usage:This system is used for making X-ray exposures for diagnostics       With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image.  When such an image is mirrored back inside the PACS system; an unmirrored "R in a circle" appears in the lower left corner.  This can be mistaken for a "Right patient side" marker; although this can appear on the left patient side.

Siemens Medical Solutions USA; Inc        Dec-06-2012       Siemens Mobilette Mira – Siemens Mobilette Mira; intended use as Mobile x-ray system.     There is a risk of lost images during examination.

Hospira Inc.        Dec-07-2012       Plum A+ Single Channel Infusion Pumps with MedNet Software – Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking; allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira; Inc.; Lake Forest; IL 60045; pump list #20679 and 20792; module list number 20677.The Plum A+ Infusion System with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking; allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature. The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual – the direction for Loud and Quiet may be reversed.  The manual indicates a clockwise rotation of the knob decreases the volume; however; on some of the devices the alarm volume increases when the knob is turned clockwise.

Hospira Inc.        Dec-07-2012       Plum A+ Hyperbaric Single Channel Infusion Pumps – Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking; allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira; Inc.; Lake Forest; IL 60045; pump list number 11005; module list number 11006  Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.     The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual – the direction for Loud and Quiet may be reversed.  The manual indicates a clockwise rotation of the knob decreases the volume; however; on some of the devices the alarm volume increases when the knob is turned clockwise.

Hospira Inc.        Dec-07-2012       Plum A+ Single Channel Infusion Pumps – Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira; Inc.; Lake Forest; IL 60045; pump list number 11971; module list numbers 12101; 12102 and 12393; pump list number 11973; module list number 12380; pump list number 12391; module list numbers 12097 and 12680Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care; including ICU/CCU; OR; PACU; ER; Med/Surg; Pediatrics; Outpatient clinics and Home care                The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual – the direction for Loud and Quiet may be reversed.  The manual indicates a clockwise rotation of the knob decreases the volume; however; on some of the devices the alarm volume increases when the knob is turned clockwise.

Roche Molecular Systems; Inc.  Dec-07-2012       AMPLILINK – AMPLILINK software; For use with COBAS¿ AmpliPrep instrument; COBAS¿ TaqMan¿ analyzer; COBAS¿ TaqMan¿ 48 analyzer; COBAS¿ AMPLICOR¿ analyzer; and Cobas p 630 instrumentAMPLILINK software is used to integrate all instruments and analyzers offering a single user interface for PCR testing. Symantec; a third party software vendor; informed  Roche about a defect in their pcAnywhere software (versions 12.6.6 and older); which is a software product for accessing PCs remotely.  The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on.  The following Roche products are potentially affected by this issue:  AMP

Roche Molecular Systems; Inc.  Dec-07-2012       DataCare POC – DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.           Symantec; a third party software vendor; informed  Roche about a defect in their pcAnywhere software (versions 12.6.6 and older); which is a software product for accessing PCs remotely.  The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on.  The following Roche products are potentially affected by this issue:  AMP

Roche Molecular Systems; Inc.  Dec-07-2012       DataCare GM – DataCare GMDataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.  Symantec; a third party software vendor; informed  Roche about a defect in their pcAnywhere software (versions 12.6.6 and older); which is a software product for accessing PCs remotely.  The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on.  The following Roche products are potentially affected by this issue:  AMP

Roche Molecular Systems; Inc.  Dec-07-2012       Instrument Manager – DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument  systems and LIS systems.                Symantec; a third party software vendor; informed  Roche about a defect in their pcAnywhere software (versions 12.6.6 and older); which is a software product for accessing PCs remotely.  The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on.  The following Roche products are potentially affected by this issue:  AMP

Roche Molecular Systems; Inc.  Dec-07-2012       cobas¿ Integra 400/400 Plus – cobas¿ Integra 400/400 Plus (Software version 3.4)The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated; computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.                Symantec; a third party software vendor; informed  Roche about a defect in their pcAnywhere software (versions 12.6.6 and older); which is a software product for accessing PCs remotely.  The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on.  The following Roche products are potentially affected by this issue:  AMP

Roche Molecular Systems; Inc.  Dec-07-2012       cobas¿ 8000 modular analyzer series – cobas¿ 8000 modular analyzer series The COBAS 8000 data manager modular analyzer series (all versions)  is a is a fully automated; random-access; software- controlled system for immunoassay and photometric  analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.      Symantec; a third party software vendor; informed  Roche about a defect in their pcAnywhere software (versions 12.6.6 and older); which is a software product for accessing PCs remotely.  The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on.  The following Roche products are potentially affected by this issue:  AMP

Roche Molecular Systems; Inc.  Dec-07-2012       LightCycler 2.0 – Roche LightCycler 2.0 Instrument with software version 4.1.  LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid); as well as post-PCR analysis of the amplified NA by melting curve analysis.          Symantec; a third party software vendor; informed  Roche about a defect in their pcAnywhere software (versions 12.6.6 and older); which is a software product for accessing PCs remotely.  The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on.  The following Roche products are potentially affected by this issue:  AMP

Roche Molecular Systems; Inc.  Dec-07-2012       LightCycler 1.2 – Roche Molecular Biochemicals LightCycler 1.2 with software version 3.5.  LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid); as well as post-PCR analysis of the amplified NA by melting curve analysis        Symantec; a third party software vendor; informed  Roche about a defect in their pcAnywhere software (versions 12.6.6 and older); which is a software product for accessing PCs remotely.  The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on.  The following Roche products are potentially affected by this issue:  AMP

Roche Molecular Systems; Inc.  Dec-07-2012       MagNA Pure 96 System – Roche MagNA Pure 96 System Version 1.0 (Software Version 2.0) for in vitro diagnostic use.  The MagNA Pure 96 System (versions 1.0 and 2.0)  is a sample preparation  instrument  for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument.  There are no corresponding assays.            Symantec; a third party software vendor; informed  Roche about a defect in their pcAnywhere software (versions 12.6.6 and older); which is a software product for accessing PCs remotely.  The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on.  The following Roche products are potentially affected by this issue:  AMP

Roche Molecular Systems; Inc.  Dec-07-2012       MagNA Pure LC – Roche Applied Science MagNA Pure LC Version 3.0. The MagNA Pure LC (version 3.0) is a sample preparation  instrument  that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.         Symantec; a third party software vendor; informed  Roche about a defect in their pcAnywhere software (versions 12.6.6 and older); which is a software product for accessing PCs remotely.  The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on.  The following Roche products are potentially affected by this issue:  AMP

Covidien LLC dba Uni-Patch         Dec-10-2012       Reusable; non-sterile; self-adhering electrodes for use with TENS/NMES – Reusable; non-sterile; self-adhering electrodes for use with TENS/NMES; .  Made in the U.S.A.  Cutaneous electrode is an electrode that is applied directly to a patient’s skin either to record physiological signals (e.g.; the electroencephalogram) or to apply electrical stimulation.    Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.

Covidien LLC dba Uni-Patch         Dec-10-2012       Reusable; Self-Adhering TENS/NMES/FES electrodes – Reusable; Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only.   An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.          Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.

Covidien LLC dba Uni-Patch         Dec-10-2012       Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes; – Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes;  A cutaneous electrode is an electrode that is applied directly to a patient’s skin either to record physiological signals (e.g.; electroencephalogram) or to apply electrical stimulation.         Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.

Covidien LLC dba Uni-Patch         Dec-10-2012       Empi STIMC RE Self Adhesive electrodes – Empi STIMC RE Self Adhesive electrodes.  For use on TENS; NMES; FES.  a DJO brand   A cutaneous electrode is an electrode that is applied directly to a patient’s skin either to record physiological signals (e.g.; electroencephalogram) or to apply electrical stimulation.                Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.

Parks Medical Electronics; Inc     Dec-10-2012       Cardiovascular blood flowmeter – Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI).  All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories.   Affected models include *2100-SX; 3000 series; 2017; 2016; 2015; 2014; 1059; 1059-A; *1059-C; *1058-C; 4000 series; 1100 series; 1060 series; 1080 series; 234 and 246. (* = current production model)All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.                Parks Medical Electronics; Inc. was made aware of  two incidents where an air supply tube from their PARKS PVR unit  was inadvertently connected to an IV in the patient’s arm instead of into the blood pressure cuff.

Philips Healthcare Inc.    Dec-10-2012       Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX – Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display physiologic waves; parameters; and trends; format data for strip chart recordings and printed reports; and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms; physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.               Internal audio cable may have diminished retention force due to damaged contacts; which could lead to intermittent or loss of audible alarms.

ConMed Corporation     Dec-10-2012       WANG Transbronchial Aspiration Needles – WANG Transbronchial Aspiration Needles Cat. No. MW-221;  WANG Cytology Needles; Central or Peripheral Regions; 21 g x 15 mm long needle. — Common Name: Bronchoscope (flexible or rigid) and accessories.  The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope.  They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma.   These are disposable sterile; single-use devices.                ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope.  If the device will not fit through the instrument channel of a 2.0 mm bronchoscope; it must be replaced with an alternate device and could result in minor inconvenience to the user.

ConMed Corporation     Dec-10-2012       WANG Transbronchial Aspiration Needles – WANG Transbronchial Aspiration Needles Cat. No. MW-322;  WANG Cytology Needles; Central; Mediastinal and Hilar Regions; 22 g x 13 mm long needle. — Common Name: Bronchoscope (flexible or rigid) and accessories.  The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope.  They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma.   These are disposable sterile; single-use devices.                ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope.  If the device will not fit through the instrument channel of a 2.0 mm bronchoscope; it must be replaced with an alternate device and could result in minor inconvenience to the user.

ConMed Corporation     Dec-10-2012       WANG Transbronchial Aspiration Needles – WANG Transbronchial Aspiration Needles Cat. No. MW-222;  WANG Cytology Needles; Central or Peripheral Regions; 22 g x 13 mm long needle. — Common Name: Bronchoscope (flexible or rigid) and accessories.  The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope.  They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma.   These are disposable sterile; single-use devices.                ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope.  If the device will not fit through the instrument channel of a 2.0 mm bronchoscope; it must be replaced with an alternate device and could result in minor inconvenience to the user.

ConMed Corporation     Dec-10-2012       WANG Transbronchial Aspiration Needles – WANG Transbronchial Aspiration Needles Cat. No. SW-121;  WANG Cytology Needles; Central; Carinal and Mediastinal Regions; 21 g x 15 mm long needle. — Common Name: Bronchoscope (flexible or rigid) and accessories.  The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope.  They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma.   These are disposable sterile; single-use devices.                ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope.  If the device will not fit through the instrument channel of a 2.0 mm bronchoscope; it must be replaced with an alternate device and could result in minor inconvenience to the user.

Mindray DS USA; Inc. d.b.a. Mindray North America        Dec-11-2012       Mindray DS USA Inc. – DPM 6/7 Patient MonitorManufactured in China for : Mindray DS USA; Inc.800 MacArthur Blvd.Mahwah; NJ 07430 USA.Intended to be used for monitoring; displaying; reviewing; storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection; ST Segment analysis; heart rate (HR) ; respiration rate (RESP); temperature (TEMP); pulse oxygen saturation (SpO2); pulse rate (PR); non-invasive blood pressure (NIBP); invasive blood pressure (IBP); carbon dioxide (CO2); anesthetic gas (AG);impedance cardiograph (ICG); bispectral index (BIS); cardiac output (C.O.) and respiration mechanics (RM).  There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure; Drug; Hemodynamic Calculations; Renal Calculations; Oxygenation Calculations; and Ventilation Calculations.

Siemens Healthcare Diagnostics; Inc        Dec-11-2012       Siemens Healthcare BNP (8-type Natriuretic Peptide) – Siemens Healthcare BNP (8-type Natriuretic Peptide)500 Test kit 02816634100 Test 02816138 10309045; 10309044 028Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS); this test; in conjunction with other known risk factors; can also be used to predict survival as well as to predict the likelihood of future heart failure.      Operating range of the ADVIA Centaur systems is 18?C to 30?C (64.4?F to 86.0?F); a change in room temperature may increase or decrease assay results; depending on the specific assay and ADVIA Centaur system used.

Siemens Healthcare Diagnostics; Inc        Dec-11-2012       Siemens Healthcare BR Assay for CA 27.29 – Siemens Healthcare BR Assay for CA 27.29250 Test Kits 0389621650 Test Kit 02419937Ref Kit (US only) 10340081Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer.      Operating range of the ADVIA Centaur systems is 18?C to 30?C (64.4?F to 86.0?F); a change in room temperature may increase or decrease assay results; depending on the specific assay and ADVIA Centaur system used.

Siemens Healthcare Diagnostics; Inc        Dec-11-2012       Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) – Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02)250 Test            0883875350 Test            03009619Intended Use For in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.        Operating range of the ADVIA Centaur systems is 18?C to 30?C (64.4?F to 86.0?F); a change in room temperature may increase or decrease assay results; depending on the specific assay and ADVIA Centaur system used.

Siemens Healthcare Diagnostics; Inc        Dec-11-2012       Siemens Healthcare ADVIA Centaur DHEA-504 – Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS)50 Test 06489701The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma using the ADVIA Centaur and ADVIA Centaur XP systems Operating range of the ADVIA Centaur systems is 18C to 30?C (64.4?F to 86.0?F); a change in room temperature may increase or decrease assay results; depending on the specific assay and ADVIA Centaur system used.

Siemens Healthcare Diagnostics; Inc        Dec-11-2012       Siemens Healthcare ADVIA Centaur Digitoxin – Siemens Healthcare ADVIA Centaur Digitoxin (DGTN)250 Test            0904641950 Test            08861968Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.                Operating range of the ADVIA Centaur systems is 18?C to 30?C (64.4?F to 86.0?F); a change in room temperature may increase or decrease assay results; depending on the specific assay and ADVIA Centaur system used.

Siemens Healthcare Diagnostics; Inc        Dec-11-2012       Siemens Healthcare ADVIA Centaur Folate (FOL) – Siemens Healthcare ADVIA Centaur Folate (FOL)500 Test            06891541100 Test            06367974Ref Kit (US only)   09132781Ref Kit (US only)   00203473Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems.      Operating range of the ADVIA Centaur systems is 18C? to 30?C (64.4?F to 86.0?F); a change in room temperature may increase or decrease assay results; depending on the specific assay and ADVIA Centaur system used.

Siemens Healthcare Diagnostics; Inc        Dec-11-2012       Siemens Healthcare  ADVIA Centaur CA 19-9 – Siemens Healthcare  ADVIA Centaur CA 19-9250 Test 1049124450 Test 10491379Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen; in human serum; using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas.         Operating range of the ADVIA Centaur systems is 18C to 30?C (64.4?F to 86.0?F); a change in room temperature may increase or decrease assay results; depending on the specific assay and ADVIA Centaur system used.

Quasar Bio-Tech; Inc. dba Silver Bay LLC Dec-12-2012       Quasar MD – Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***"The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness; minor arthritis pain; or muscle spasm. This device may temporarily increase local blood circulation; and may be used to promote relaxation of the muscle tissue.             Quasar Bio-Tech is recalling their Baby Quasar; Baby Quasar Pink; Quasar Power Pack; and Quasar MD because the device is unapproved.

Quasar Bio-Tech; Inc. dba Silver Bay LLC Dec-12-2012       Quasar Power Pack – Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne.The Quasar Power Pack is labeled in part: "***BABY QUASAR & BABY BLUE***QUASAR POWERPACK***FOR YOUTHFUL; RADIANT; CLEAR SKIN***SKIN REJUVENATING SYSTEM WITH SEQUEPULSE PLUS ADVANCED ACNE CLARIFYING SYSTEM***Manufactured by: Quasar Biotech; Inc.; BPP101 LAB-003-E; ***Made in the USA with highest quality components and durable aluminum. Five Year Warranty.***"           Quasar Bio-Tech is recalling their Baby Quasar; Baby Quasar Pink; Quasar Power Pack; and Quasar MD because the device is unapproved.

Quasar Bio-Tech; Inc. dba Silver Bay LLC Dec-12-2012       Baby Quasar & Baby Quasar Pink – Baby Quasar (LAB-001-D; BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay; LLC; Made in the USA; with highest quality components and durable aluminum. Five Year WarrantyThe product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness; minor arthritis pain; or muscle spasm. This device may temporarily increase local blood circulation; and may be used to promote relaxation of the muscle tissue.   Quasar Bio-Tech is recalling their Baby Quasar; Baby Quasar Pink; Quasar Power Pack; and Quasar MD because the device is unapproved.

Advanced Sterilization Products                Dec-12-2012       STERRAD CYCLESURE 24 Biological Indicator – STERRAD CYCLESURE 24 Biological Indicator (BI) product; P/N 14324.Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers; Product Description:14324 Sterrad Cyclesure 24 Biological Indicator.14324-02 Sterrad Cyclesure 24 Biological Indicator.10134 Sterrad 100NX Express Cycle Kit.10135 Sterrad 100NX Express Cycle Upgrade Kit.10137 Sterrad 100NX Duo Cycle Upgrade kit.14325 Cyclesure Challenge Pack Kit.20103 Sterrad 100NX Test Pack Kit.20228 Sterrad 100NX Intl Validation Kit.20229 Sterrad 100NX Validation Kit; USA.20232 Sterrad 50/100S Validation Kit.20236 Sterrad 50/100S Validation Kit.20248 Sterrad 100NX Express Validation Kit.20253 Sterrad NX Validation Kit.20254 Sterrad NX Validation Kit Domestic; US.The Sterrad Cyclesure 24 Biological Indicator (BI); P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.  Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December 2011 because it may not have adequate data to support the entire duration of the labeled shelf-life.

Siemens Medical Solutions USA; Inc        Dec-12-2012       MAVIG PORTEGRA 2 system – MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX systemCeiling mounted surgical light A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems.

Leica Microsystems; Inc.               Dec-13-2012       Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase – Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No. RTU-TdT-339; packaged in 7 mL vials; Leica Biosystems Newcastle Ltd.; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom. RTU-TdT-339 is intended for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.               RTU-TdT-339 is not stable up to the expiry date on the product labeling; affecting the staining intensity.

Becton Dickinson & Co. Dec-13-2012       BD BBL Taxo XV Factor Strips – BD BBL Taxo XV Factor Strips; Catalog number 231104; in shelf pack vials; fifty strips/vial labeled in part ***Becton; Dickinson and Company; 7 Loveton Circle; Sparks; MD 21152 USA 800-638-8663; www.bd.com/ds***               In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens.

Roche Diagnostics Operations; Inc.          Dec-13-2012       Cobas b 123 POC system – Cobas b 123 POC systemcobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH; blood gases (BG); electrolytes Na+ K+; iCa2+ (ISE); hematocrit (Hct); metabolites (Gluc; Lac); total hemoglobin (tHb); hemoglobin derivatives (O2Hb; HHB; COHB; MetHb); and oxygen saturation (SO2). In addition; the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory.            It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171; exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. Internal investigations found the altered thickness of the cuvette was due to production equipment settings. Cuvettes were produced within specifications; but within the upper

GE Healthcare; LLC          Dec-14-2012       Carescape Patient Data Module v2.0 – GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l; Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult; pediatric and neonatal patients during bedside and transport patient care episodes.      GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.

GE Healthcare; LLC          Dec-16-2012       GE Healthcare; Dash 3000/4000/5000. – GE Healthcare; Dash 3000/4000/5000.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; respiratory intensive care; coronary care; medical intensive care; pediatric 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 limited to: electrocardiogram; invasive blood pressure; noninvasive blood pressure (NBP); heart rate; temperature; cardiac output; respiration; pulse oximetry; carbon dioxide; bi-spectral index; impedance cardiography; oxygen; and anesthetic agents as summarized in the operator’s manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORKTM 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.               GE Healthcare has recently become aware of a potential issue due to an unexpected loss of CustomAutomatic NBP Measurement cycling associated with the Dash 3000/4000/5000 patient monitors.

Arobella Medical; LLC     Dec-17-2012       AR1000 Qoustic Qurette" – Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator; converter hand piece; done-shaped applicator tip (qurette); and a saline supply reservoir. Product Usage:The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue; wound debridement ( of acute and chronic wounds; burns; and diseased or necrotic tissue); and cleansing irrigation of the wound site for the removal of debris; exudates; fragments; and other matter.  This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component of the AR1000 Quostic Wound Therapy System.

Biomet; Inc.        Dec-17-2012       Biomet Offset Tibial Tray Adaptor – Biomet Offset Tibial Tray 2.5 mm Adaptor; REF 141490Sterile; QTY.1Product Usage:Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral; tibial; and patellar components; intended for both primary and revision applications. Indications: 1) painful and disabled knee joint resulting from osteoarthritis; rheumatoid arthritis; traumatic arthritis when one or more compartments are involved; 2) correction of varus; valgus; or posttraumatic deformity; 3) correction or revision of unsuccessful osteotomy; arthrodesis; or failure of previous joint replacement procedure           Biomet investigation identified that the square end of the offset tibial tray adaptor locking insert is oversized and may not engage insert tool screwdriver.   This could cause a possible delay in surgery greater than 30 minutes; potentially exposing the patient to the increased risks from being under anesthesia for a longer duration.

Mindray DS USA; Inc. d.b.a. Mindray North America        Dec-17-2012       Mindray – Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1  Manufactured in China  Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1  Manufactured in China One product; V Series monitor; available in two sizes:  The V12 has a 12 inch screen; the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3; 5; 6 and 12 lead measurements; 2) Heart Rate; 3) Pulse Oximetry (Sp O2); 4) ST Segment Analysis; 5) Arrhythmia Detection; 6) Non Invasive Blood Pressure (NIBP); 7) Invasive Blood Pressure (IBP); 8) Cardiac Output (CO); 9) Respiratory Gasses; 10) Respiration Rate; 11) Temperature; It is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.       Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.

EEG Info               Dec-17-2012       EEG NeuroAmp – EEG NeuroAmp; Model Number: CS 10090; CS 10137.Biofeedback and Relaxation           EEG Info; Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices.

Medline Industries Inc   Dec-17-2012       Medline Total Knee CDS – Medline Total Knee CDS; a single patient prescription procedure pack and disposables; including a back table cover;Product Usage:  This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure.  The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pack when it should have been in the sterile portion.

Varian Medical Systems; Inc. Oncology Systems                Dec-17-2012       Varian brand ARIA Radiation Oncology – Varian brand ARIA Radiation Oncology; ARIA Oncology Information System Radiation Oncology; Import Export Application; Model Number: HIT; Affected Versions: ARIA version 11.0 below 11.0.55; Build 11.0.28 and 11.0.34; Reference/FSCA Identifier: CP-09798;Product is manufactured and distributed by Varian Medical Systems Inc.; Palo Alto; CA     Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or import.

DePuy Mitek; Inc.; a Johnson & Johnson Co.       Dec-17-2012       DePuy Mitek Sterile Reamers – DePuy Mitek 11 MM Fully Fluted Reamer; SterileProduct Number: 232423DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.   Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly;  7 units were labeled as 11MM while the box actually contained a 10 MM reamer

Ebi; Llc   Dec-17-2012       Biomet Polaris 5.5 – Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178                Broken screw insertor hardness was measured and found to be below the acceptable limits.

TITAN SPINE; LLC              Dec-17-2012       "Titan Spine Endoskeleton TA Implant – Titan Spine Endoskeleton TA Implant products. 2107-0118       18mm Standard Endoskeleton Implant VBR 2107-0120    20mm Standard Endoskeleton Implant VBR2107-0218   18mm Large Endoskeleton Implant VBR2107-0220            20mm Large Endoskeleton Implant VBREndoskeleton TA VBR is intended for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed; damaged; or unstable vertebral body due to tumor or trauma."                Titan Spine LLC; is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.

Biomet; Inc.        Dec-17-2012       Biomet Rail System – EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail; modular bone screw clamps; and compression and distraction units. The device is used in the treatment of bone fractures.   It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.

ThyssenKrupp Access Corp          Dec-18-2012       ThyssenKrupp Accessibility LEVANT Stairlift. – ThyssenKrupp Accessibility LEVANT Stairlift.Intended to mechanically transport one mobility impaired person in a fold-down seat up and down straight stairs; indoors and outdoors.      The seat could break as a result of damage resulting from a seat belt being trapped underneath the foldable part of the seat when the seat belt is not buckled.

Invacare Corporation     Dec-18-2012       Cane – Invacare Height Adjustable (walking) Canes;  Model Numbers:  8916; 8917; and 40918-6.  The device is packaged six (6) canes per shipping carton. The cane is used as an aid in walking or ambulation.                Following their receipt of several customer complaints; Invacare recalled their height adjustable walking canes.  The device was recalled from distribution based on reports indicating that there is a possibility that the button which holds the cane at the desired height; may suddenly and unexpectedly compress; causing the cane to collapse and cause possible injury to the user.

Zimmer; Inc.       Dec-18-2012       Persona; The Personalized Knee System – Persona; The Personalized Knee System;   Tibial Drill Guide; Cemented; 15.7 mm Diameter; Nonsterile; NonsterileThis drill guide is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities        All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona; The Personalized Knee System – Persona; The Personalized Knee System;   Tibial Sizing Plate; Cemented; Nonsterile; Size H Left; Size H RightThis device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities       All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona The Personalized Knee System – Persona The Personalized Knee System; Natural Tibia;   Cemented; 5 Degree Stemmed Tivanium SterileSIZE C; LEFT;  SIZE C RIGHTThis device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities.      All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona The Personalized Knee System – Persona The Personalized Knee System; Natural Tibia;   Cemented; 5 Degree Stemmed Tivanium SterileThis device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities.      All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona The Personalized Knee System – Persona The Personalized Knee System; Natural Tibia;   Cemented; 5 Degree Stemmed Tivanium SterileTIBIA SIZE E; LEFTTIBIA SIZE E RIGHTThis device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities.       All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona The Personalized Knee System – Persona The Personalized Knee System; Natural Tibia;   Cemented; 5 Degree Stemmed Tivanium SterileTIBIA SIZE F; LEFTTIBIA SIZE F RIGHTThis device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities.       All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona The Personalized Knee System – Persona The Personalized Knee System; Natural Tibia;   Cemented; 5 Degree Stemmed Tivanium SterileTIBIA SIZE G; LEFTTIBIA SIZE G RIGHTThis device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities.       All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona The Personalized Knee System; Natural Tibia – Persona The Personalized Knee System; Natural Tibia;   Cemented; 5 Degree Stemmed Tivanium SterileTIBIA SIZE H; LEFTTIBIA SIZE H RIGHTThis device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities.     All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona; The Personalized Knee System – Persona; The Personalized Knee System;Tibial Drill;   Cemented; 15.7 mm Diameter; NonsterileThis device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities.     All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona; The Personalized Knee System – Persona; The Personalized Knee System;   Tibial Broach;; Cemented; Size C-D;  Nonsterile; This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities.      All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona; The Personalized Knee System – Persona; The Personalized Knee System;   Tibial Broach; Cemented; Size E-F;  Nonsterile; This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities.      All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona; The Personalized Knee System – Persona; The Personalized Knee System;   Tibial Broach; Cemented; Size G-H;  Nonsterile; This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities.      All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona; The Personalized Knee System – Persona; The Personalized Knee System;   Tibial Sizing Plate; Cemented; Nonsterile; Size C Left; Size C RightThis device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities       All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona; The Personalized Knee System – Persona; The Personalized Knee System;   Tibial Sizing Plate; Cemented; Nonsterile; Size D Left; Size D RightThis device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities       All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona; The Personalized Knee System – Persona; The Personalized Knee System;   Tibial Sizing Plate; Cemented; Nonsterile; Size E Left; Size E RightThis device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities       All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona; The Personalized Knee System – Persona; The Personalized Knee System;   Tibial Sizing Plate; Cemented; Nonsterile; Size F Left; Size F RightThis device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities       All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Persona; The Personalized Knee System – Persona; The Personalized Knee System;   Tibial Sizing Plate; Cemented; Nonsterile; Size G Left; Size G RightThis device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis. o Collagen disorders; and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. o Moderate valgus; varus; or flexion deformities       All lots of the Persona Cemented Tibial Drill; 5 Degree Cemented Stemmed Natural Tibia implants; and associated tools including the Tibial Drill Guide; Broach; and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

Zimmer; Inc.       Dec-18-2012       Coonmad/Morrey – COONMAD/MORREY TOTAL ELBOWELBOW COMPONENT REPLACEMENT SETBUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOWELBOW COMP REPLACEMENT-REG SETSTERILE PROD CLASS: 4100OPERATION:9000QTY/PKG:1Product Usage:The ulnar and humeral components are connected by placing the hollow; outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.       Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit .

Zimmer; Inc.       Dec-18-2012       Coonrad/Morrey – Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx; Tivanium QTY/PKG:1Product Usage:  The ulnar and humeral components are connected by placing the hollow; outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.              Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit .

Del Mar Reynolds Medical; Ltd. Dec-19-2012       BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators – BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine.In most cases; the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases; the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date. The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system.  The manuals were prematurely updated for a feature that is not yet available.

Becton Dickinson & Co. Dec-19-2012       BD Phoenix PMIC-108 Panels – BD Phoenix PMIC-108 Panels; Catalog number 448418; labeled in part ***Becton; Dickinson and Company 7 Loveton Circle Sparks; USA.The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.         An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.

Becton Dickinson & Company     Dec-19-2012       Becton Dickinson and Company – Case Carton:BD Oral Dispensing Syringe1 mL Clear with Tip CapBD; Franklin Lakes; NJ 07417 USA Made in USA www.bd.comBD; Laagstraat 57; B-9140 Temse; BelgiumOn 100 unit plastic bag:BD oral syringes are intended to dispense oral medications.          BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.

Integra LifeSciences Corporation              Dec-19-2012       MAYFIELD Skull Clamps – MAYFIELD Composite Series Skull Clamps; Model A3059; 510(k) #K120633.The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies; as well as spinal surgery when rigid skeletal fixation is necessary. An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm’s Mayfield Composite Series Base Units and  Mayfield Skull Clamps. In order to prevent additional complaint reports; the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d

Integra LifeSciences Corporation              Dec-19-2012       MAYFIELD Base Unit – MAYFIELD Composite Series Base Unit;  Model A3101; a Swivel Adaptor (A3018) is an integral component of the Base Unit; Model A3101.The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest; or skull clamp is necessary; positional freedom is required and where X-ray imaging modalities will be used. A Swivel Adaptor (A3018) is an integral component of the Base Unit A3101.        An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm’s Mayfield Composite Series Base Units and  Mayfield Skull Clamps. In order to prevent additional complaint reports; the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d

Medtronic Neuromodulation     Dec-19-2012       DBS Extension Kit for Deep Brain Stimulation – Medtronic; DBS Extension Kit for Deep Brain Stimulation; Catalog # 7482; 37085; 37086. Rx Only; Manufactured in: Medtronic; Inc. Villalba; Puerto Rico. Medtronic¿ DBSTM Therapy for Parkinson’s Disease – Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson’s Disease is indicated for adjunctive therapy in reducing some of the symptoms of advanced; levodopa-responsive Parkinson’s disease that are not adequately controlled with medication. STN/GPi target system components: ¿ Kinetra¿ Model 7428 or Soletra¿ Model 7426 Neurostimulator ¿ Activa¿ PC Model 37601; Activa RC Model 37612; Activa SC Model 37602; or Activa SC Model 37603 Neurostimulator ¿ Model 7482; Model 7482A; Model 7483; Model 37085; or Model 37086 Extension ¿ Model 3387 or Model 3389 Lead Medtronic DBS Therapy for Tremor – Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. VIM target system components: ¿ Soletra Model 7426 Neurostimulator ¿ Activa PC Model 37601; Activa RC Model 37612; Activa SC Model 37602; or Activa SC Model 37603 Neurostimulator ¿ Model 7482; Model 7482A; Model 7483; Model 37085; or Model 37086 Extension ¿ Model 3387 or Model 3389 Lead.                Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482; 37085; and 37086); which may contain a damaged winged connector boot. The connector boot may not have been molded properly and may be cracked. Approximately 14% of the 140 affected extension kits may contain a damaged radiopaque winged connector boot.

Dako  Denmark A/S         Dec-19-2012       CoverStainer Slide Rack – CS 10330 – CoverStainer Slide RackThe CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides; during transfer through the staining process. The rack can hold up to 10 slides at a time; and is necessary for optimal CoverStainer instrument performance.    The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements; originating from variations in the manufacturing process.

GE Healthcare; LLC          Dec-19-2012       Advantage Workstation – Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed:" VesselIQ Xpress or AVA Xpress" CardIQ Xpress Pro or Plus" CardEP" CardIQ Fusion PET or SPECTAdvantage Workstations Volume Share (v.AW4.3) and AW4.2 (version4.2-05 and above) provided with Volume Viewer 2(version6.0 to version6.11) and only when one or both of these applications is installed:" CardIQ Xpress Pro or Plus" CardEPAdvantage Workstations AW Volume Share 2 (AW version 4.4).ONLY IF ONE OF FOLLOWING APPLICATIONS IS INSTALLED:¿ VesselIQ Xpress or AVA Xpress¿ CardIQ Xpress Pro or Plus¿ CardEP¿ CardIQ Fusion PET or SPECTprovided with Volume Viewer 3 and 3.1 from versions 7.0 to 7.5 and 8.1.To verify the version installed on your system: Select the Admin menu from the Patient list page. Then select Display Configuration. You will find the version of your system in Installed Application(s). This version will appear as vxtl_7.x or vxtl_8.x.  Intended use: K993792: Smart Vessel Analysis (Smart VA) is a software post-processing option for the Advantage Workstation (AW) platform; which can be used in the analysis of 3D angiography data. It provides a number of display; measurement and batch filming/archive features and will aid physicians in studying user-selected vessels for stenosis analysis; pre/post stent planning and directional vessel tortuosity visualization. K031261: Card EP is a post processing software option for the Advantage Workstation (AW) Platform. This product can be used for the analysis of CT angiographic images for the assessment of the heart to include the atria; pulmonary veins; and coronary sinus. It provides quantitative analysis tools which include a number of display; measurement and model export capabilities. This product can be used to aid trained physicians in the visualization and assessment of cardiac anatomy. K041267: CardIQ Analysis III is a CT image analysis software package; which allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionally for 2D/3D rendering; assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery; ventricular function of the heart; and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician to process; render; review; archive; print and visualizing cardiac anatomy and coronary vessels. CardIQ Analysis II will run on the AW workstation; scanner operator console and PACS system. K061370: CardIQ Fusion is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology; aid in the assessment of functional data e.g. PET perfusion; and aid in tailoring treatment plans based on the fused anatomical and functional information. Anatomical data could be from a set of Computed Tomography (CT) Angiographic images while functional data could be from PET; SPECT; or processed CT data. CardIQ Fusion is a software post-processing package for the Advantage Workstation (AW) platform; PET/CT and CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic cardiac images/data providing a number of display; measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally; it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information. With CardIQ Fusion; clinicians have the opportunity to overlay functional information over the (CT) anatomy of a patient’s heart; and thus; they can potentially tailor their decision for that particular patient. CardIQ Fusion provides the visualization of the vessels in severa  GE Healthcare has became aware of two issues with the Advantage Workstation.1) A possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety.2) A refresh problem of the stenosis / aneurysmmeasurement tools associated with the cardio-vascular applications of

BioHorizons Implant Systems Inc              Dec-19-2012       Titanium Tack Starter Kit – Titanium Tack Starter Kit; REF 400-270; Rx Only; non-sterile; BIOHORIZONS; BIRMINGHAM; AL  35244.Dental.          The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

Stryker Medical Division of Stryker Corporation Dec-19-2012       Power Load – The Stryker Model 6390; Power-LOAD; is a power-loading cot fastener system designed to lift; lower; or steer ambulance cots into and out of the ambulance.                Model 6390 Power-LOAD systems built between September 12; 2012 and September 27; 2012 may have been built with a load switch slide that does not meet specifications causing the lifting ability of the arms to be negatively impacted.

BioHorizons Implant Systems Inc              Dec-19-2012       AutoTac Delivery Handle – AutoTac Delivery Handle; REF 400-200; Rx Only; non-sterile; BIOHORIZONS; BIRMINGHAM; AL  35244.Dental.          The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

DePuy Orthopaedics; Inc.             Dec-19-2012       Pinnacle Cancellous Screw – Pinnacle Cancellous ScrewPackaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard carton; labeled and shrink-wrapped.PINNACLE¿ CANCELLOUS Bone Screws are ancillary fixation devices used in total hip arthroplasties. These screws are used to secure PINNACLE ACETABULAR Shell implants to the acetabulum via screw holes designed in the shell. Intended Use: This product is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis; osteoarthritis; post-traumatic arthritis; collagen disorders; avascular necrosis; and nonunion of femoral fractures.                DePuy Orthopaedics; Inc. is issuing a voluntary recall of ten lots of the Pinnacle? Cancellous Screw due to an incorrect description on the label.  The label description reads Pinnacle Cannulated Screw and should read Pinnacle Cancellous Screw.

Medline Industries Inc   Dec-19-2012       Medline Angio Drape Pack Radiology-LF – Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack; including a waste bag; for use by the Interventional Radiology Department; Packaged for Medline Industries; Inc.; Reorder #DYNJ35993DThis custom pack includes components necessary for a specific procedure.          The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in its own packaging. The product was not labeled or identified as sterile; but was assumed to be sterile by the customer.

Medrad Inc         Dec-20-2012       Medrad(R) Continuum MR Infusion Pump – Medrad(R) Continuum MR Infusion PumpPeristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to; during and immediately after the MR procedure functioning while either stationary or mobile.         Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore); catalog numbers MIK200A; MIL 200B; 3015153; 3015155; 3015156; 3015157; 3015158; 3015159; and 3015161.  The firm is initiating this recall because this tubing exhibits a variation that; when used in conjunction with any Continuum pump; may result in flow rate accuracy performance issues.

Medrad Inc         Dec-20-2012       Medrad(R) Continuum MR Infusion System Standard Administration Kit – Medrad(R) Continuum MR Infusion System Standard Administration KitPeristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to; during and immediately after the MR procedure functioning while either stationary or mobile.         Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore); catalog numbers MIK200A; MIL 200B; 3015153; 3015155; 3015156; 3015157; 3015158; 3015159; and 3015161.  The firm is initiating this recall because this tubing exhibits a variation that; when used in conjunction with any Continuum pump; may result in flow rate accuracy performance issues.

Medrad Inc         Dec-20-2012       Medrad(R) Continuum MR Infusion System Secondary Administration Kit – Medrad(R) Continuum MR Infusion System Secondary Administration KitPeristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to; during and immediately after the MR procedure functioning while either stationary or mobile.         Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore); catalog numbers MIK200A; MIL 200B; 3015153; 3015155; 3015156; 3015157; 3015158; 3015159; and 3015161.  The firm is initiating this recall because this tubing exhibits a variation that; when used in conjunction with any Continuum pump; may result in flow rate accuracy performance issues.

Medrad Inc         Dec-20-2012       Medrad(R) Continuum MR Infusion System Primary Set – Medrad(R) Continuum MR Infusion System Primary SetPeristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to; during and immediately after the MR procedure functioning while either stationary or mobile.              Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore); catalog numbers MIK200A; MIL 200B; 3015153; 3015155; 3015156; 3015157; 3015158; 3015159; and 3015161.  The firm is initiating this recall because this tubing exhibits a variation that; when used in conjunction with any Continuum pump; may result in flow rate accuracy performance issues.

Medrad Inc         Dec-20-2012       Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set – Medrad(R) Continuum MR Infusion System Primary VSA Stopcock SetPeristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to; during and immediately after the MR procedure functioning while either stationary or mobile.         Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore); catalog numbers MIK200A; MIL 200B; 3015153; 3015155; 3015156; 3015157; 3015158; 3015159; and 3015161.  The firm is initiating this recall because this tubing exhibits a variation that; when used in conjunction with any Continuum pump; may result in flow rate accuracy performance issues.

Medrad Inc         Dec-20-2012       Medrad(R) Continuum MR Infusion System Side Step Set – Medrad(R) Continuum MR Infusion System Side Step SetPeristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to; during and immediately after the MR procedure functioning while either stationary or mobile.              Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore); catalog numbers MIK200A; MIL 200B; 3015153; 3015155; 3015156; 3015157; 3015158; 3015159; and 3015161.  The firm is initiating this recall because this tubing exhibits a variation that; when used in conjunction with any Continuum pump; may result in flow rate accuracy performance issues.

Medrad Inc         Dec-20-2012       Medrad(R) Continuum MR Infusion System Primary Spike Set – Medrad(R) Continuum MR Infusion System Primary Spike SetPeristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to; during and immediately after the MR procedure functioning while either stationary or mobile.              Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore); catalog numbers MIK200A; MIL 200B; 3015153; 3015155; 3015156; 3015157; 3015158; 3015159; and 3015161.  The firm is initiating this recall because this tubing exhibits a variation that; when used in conjunction with any Continuum pump; may result in flow rate accuracy performance issues.

Medrad Inc         Dec-20-2012       Medrad(R) Continuum MR Infusion System Secondary Set – Medrad(R) Continuum MR Infusion System Secondary SetPeristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to; during and immediately after the MR procedure functioning while either stationary or mobile.              Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore); catalog numbers MIK200A; MIL 200B; 3015153; 3015155; 3015156; 3015157; 3015158; 3015159; and 3015161.  The firm is initiating this recall because this tubing exhibits a variation that; when used in conjunction with any Continuum pump; may result in flow rate accuracy performance issues.

Medrad Inc         Dec-20-2012       Medrad(R) Continuum MR Infusion System Secondary Spike Set – Medrad(R) Continuum MR Infusion System Secondary Spike SetPeristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to; during and immediately after the MR procedure functioning while either stationary or mobile.      Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore); catalog numbers MIK200A; MIL 200B; 3015153; 3015155; 3015156; 3015157; 3015158; 3015159; and 3015161.  The firm is initiating this recall because this tubing exhibits a variation that; when used in conjunction with any Continuum pump; may result in flow rate accuracy performance issues.

Medrad Inc         Dec-20-2012       Medrad(R) Continuum MR Infusion System Secondary VSA Set – Medrad(R) Continuum MR Infusion System Secondary VSA SetPeristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to; during and immediately after the MR procedure functioning while either stationary or mobile.      Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore); catalog numbers MIK200A; MIL 200B; 3015153; 3015155; 3015156; 3015157; 3015158; 3015159; and 3015161.  The firm is initiating this recall because this tubing exhibits a variation that; when used in conjunction with any Continuum pump; may result in flow rate accuracy performance issues.

Medrad Inc         Dec-20-2012       Medrad(R) Continuum MR Infusion System Primary VSA Set – Medrad(R) Continuum MR Infusion System Primary VSA SetPeristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to; during and immediately after the MR procedure functioning while either stationary or mobile.              Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore); catalog numbers MIK200A; MIL 200B; 3015153; 3015155; 3015156; 3015157; 3015158; 3015159; and 3015161.  The firm is initiating this recall because this tubing exhibits a variation that; when used in conjunction with any Continuum pump; may result in flow rate accuracy performance issues.

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS 8IN CALC 1.5/18.0 – SOL SYS 8IN CALC 1.5/18.0Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.     An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS R 9IN CALC 2.25/22.5 – SOL SYS R 9IN CALC 2.25/22.5Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.   An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS R 9IN CALC 2.25/21 – SOL SYS R 9IN CALC 2.25/21Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.  Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.     An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS 8IN CALCAR SZ12 – SOL SYS 8IN CALCAR SZ12Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.     An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS F 8 CALC 13.5MM LG – SOL SYS F 8 CALC 13.5MM LGPackaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.   An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS 8IN CALC 1.5/15.0 – SOL SYS 8IN CALC 1.5/15.0Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.     An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS 8IN CALC 1.5/16.5 – SOL SYS 8IN CALC 1.5/16.5Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.     An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

BioMotion Medical Systems; LLC               Dec-20-2012       SpineSix01/SpineSix02 – SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen that displays treatment time; positioning and magnitude and direction of motion.There are eight fully customizable Patient Protocol settings for commonly usedtreatment settings.The SpineSix BioMotion Spinal System is intended to reproduce normal spine mechanics and physiological movements so that a patient can comfortably and safely experience functional range of motion in a non-weight-bearing environment. BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to rectify all regulatory deficiencies involving the former owners of the SpineSix product and concurrently preparing the submission of a 510(k) application in order to receive premarket clearance for SpineSix.

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS 8IN CALC 1.5/19.5 – SOL SYS 8IN CALC 1.5/19.5Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.     An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS F 9 CALC L 13.5MM LG – SOL SYS F 9 CALC L 13.5MM LGPackaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.   An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS L 9IN CALC 2.25/15.0 – SOL SYS L 9IN CALC 2.25/15.0Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.   An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS L 9IN CALC 2.25/16.5 – SOL SYS L 9IN CALC 2.25/16.5Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.   An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS L 9IN CALC 2.25/18 – SOL SYS L 9IN CALC 2.25/18Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.     An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS L 9IN CALC 2.25/19.5 – SOL SYS L 9IN CALC 2.25/19.5Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.   An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS L 9IN CALC 2.25/21 – SOL SYS L 9IN CALC 2.25/21Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.     An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS L 9IN CALC 2.25/22.5 – SOL SYS L 9IN CALC 2.25/22.5Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.   An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS F 9 CALC L 13.5MM LG – SOL SYS F 9 CALC L 13.5MM LGPackaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.   An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS R 9IN CALC 2.25/15.0 – SOL SYS R 9IN CALC 2.25/15.0Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.   An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS R 9IN CALC 2.25/16.5 – SOL SYS R 9IN CALC 2.25/16.5Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.   An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS R 9IN CALC 2.25/18 – SOL SYS R 9IN CALC 2.25/18Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.     An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

DePuy Orthopaedics; Inc.             Dec-20-2012       SOL SYS R 9IN CALC 2.25/19.5 – SOL SYS R 9IN CALC 2.25/19.5Packaging: Product is packed within a poly protector; with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton; labeled; and shrink wrapped.    Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.   An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a

Varian Medical Systems; Inc.      Dec-20-2012       Segmented Cervix Applicator – Segmented Cervix Applicator Set; part number GM11004310; a component used with the tube for segments and cervical sleevesThe guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix; vagina; endometrium; vaginal stump and uterus. It is used for Brachytherapy.  The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.

Beckman Coulter Inc.     Dec-20-2012       Access hLH Calibrators – The Access hLH assay is a paramagnetic particle; chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.                Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points.  Per BEC’s real time stability procedure; in order to verify expiration dating; one additional month is needed beyond the claimed expiration period. Therefore; these lots did not meet BEC’s procedural requirements for a 12-month shelf-lif

Bausch & Lomb Inc          Dec-20-2012       Bausch + Lomb Stellaris PC Vision Enhancement System; Posterior Fluidics Module (PFM) – Bausch + Lomb Stellaris PC Vision Enhancement System; Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts; anterior; and posterior segment vitrectomy.      Posterior fluidics modules installed in the system may need to be recalibrated.

Philips Medical Systems (Cleveland) Inc Dec-21-2012       Computed Tomography X-Ray System; Extended Brilliance Workspace ( EBW) – Computed Tomography X-Ray System; Extended Brilliance Workspace (EBW); Model #728260 Philips Healthcare; Highland Heights; OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5.  The update will provide a number of improvements to address nonhazardous reliability issues which will improve the overall quality and functionality of the EBW.

Beckman Coulter Inc.     Dec-22-2012       Access Immunoassay Systems Total T4 Calibrators – Access Immunoassay Systems Total T4 Calibrators; Part Number: 33805.The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.      A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818; 021654; and 024072 do not meet their 12 month expiration date claim.

Stryker Howmedica Osteonics Corp.       Dec-22-2012       T2 Humerus Sterile Teflon Tube – Stryker Howmedica Osteonics; Stryker T2 Humerus SystemTeflon Tube; sterile; REF 1806-0073SThe T2 Nailing System is designed to treat complex fractures in Humeral; Femoral; Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip Guide Wire with the Smooth Tip Guide Wire once reaming is completed.Stryker Stryker Trauma GmbH 24232 Schonkirchen; Germanydistributed in USA by:  Howmedica Osteonics Corp.; 235 Corporate Drive;            During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube.

sanofi-aventis US; Inc.   Dec-22-2012       Sanofi Aventis Diamigo i-Phone App – Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.               Diamigo; a software application; was released through the i-Phone Global Store which inadvertently allowed global access to the application as opposed to the original intended restriction of access to Brazil.

Beckman Coulter Inc.     Dec-22-2012       Access Immunoassay System – Access Immunoassay System;Access 2 Immunoassay System;Synchron LXi 725 ClinicalSystem; UniCel DxC 600iSynchron Access Clinical SystemPart Numbers: Access  81600;Access 2  81600N; 386220; A69186; A25656; A12900;Access 2 (LXi)  A15642;Access 2 Section; DxC 600i  A25640.The Access Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer.     It has been determined that; in some cases;pulley drive components have broken parts or have become loose; mispositioned; ordisconnected from their drive shafts. When these defects occur; the pulley may not turn at all; ormay turn at an incorrect speed; resulting in inadequate washing or mixing of the contents of thereaction vessel.

Greatbatch Medical        Dec-22-2012       MobiCath Bi-Directional Guiding Sheath – Biosense Webster MobiCath Bi-Directional Guiding Sheath.  Small Curve catalog no. D140010; Large Curve catalog no. D140011.  The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems.  The device features adjustable tip geometry through use of a rotating handle to deflect the catheter.  This catheter is assembled with a hemostasis valve and a sideport infusion line.The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart; including the left side of the heart through the interatrial septum.          Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool.  The anomalies may include loose; string-like liner material; liner abrasion (fraying); and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen).

Roche Molecular Systems; Inc.  Dec-23-2012       Roche COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) – COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5Automated sample processing instrument used with CAP/CA and CAP/CTM.Roche Molecular Systems; Inc.1080 US Highway 202 SouthBranchburg; NJ 08876USAMade in Switzerland        Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.

Arjo; Inc. dba ArjoHuntleigh        Dec-27-2012       Flowtron Trio Pump – Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB; Eslov; Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis.               The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.

Brookstone Company; Inc.          Dec-27-2012       Brookstone Heated Body Bean – Brookstone Heated Body Bean; electrically heated SKU numbers: 734863 (BlNationwide Distributionue); 734864 (Plum); 734865 (Red).Brookstone 3 in 1 wrap ;SKU734397 (Brown).The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to use.    Additional Warning Statement  to prevent burns to the skin

SynCardia Systems Inc.  Dec-28-2012       Syncardia – Companion External Battery; Part Number: 293001-001The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems; with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.            Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal events and/or other physical damage such as melting; charring and/or burning.

Medtronic Inc. Cardiac Rhythm Disease Management    Dec-28-2012       Medtronic Intersept Tubing Packs – Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact; Carmeda BioActive Surfact and Trillium Biosurface;or Balance Biosurface) with the following Model numbers:0E27R16; 1A30R6; 2493R24; 2493R25; 5D56R5; 5Z93R4; 5Z93R5; 7E64R2; 7J53R2; 7M13R1; 7M14R1; 7N16R; 7P25R1; 7P93R1; 7Q11R1; BB7L63R2; BB7N26R; CB5174R11; CB175R13; CB5Q03R6; CB5Q03R7; CB6C53R6; CB7C15R2; CB7C59R2; CB7C60R2; CB7C74R2; CB7D91R5; CB7E35R2; CB7E38R1; CB7G21R4; CB7L48R1; CB7L72R1; CB7P82R1; HY6U96R2; HY6Y52R2; HY7E87R1; SS7J91R3; SSCB7L48R; SSTL7G78R1;TL5S33R7; TL6VTTR1; TL7B51R1; TL7G20R3; TL7G78R3; TL7R87R1. Sterilized Using Ethylene Oxide; Nonpyrogenic; Assembled in Mexico; Manufacturer Medtronic; Inc; Minneapolis; Mn 55432Product is used by perfusionists as part of the extracorporeal circuit during cardiopulmonary bypass procedures; and is configured specifically as designated by each customer.         Medtronic is initiating an Urgent Medical Device Customer Notification.  We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility.