May-01-2014      Hospira Inc.        GemStar Docking Station – GemStar Docking Station; used with GemStar infusion pump; in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord.  The docking station is also used for hosting the GemStar pump for general infusions.  List Numbers: 13075-XX-XX.        There are two situations that may occur when using the GemStar Docking Station; List Number 13075-XX-XX; in conjunction with the GemStar infusion pump: 1) when the Docking Station is used in conjunction with a GemStar Phase 3 pump (List 13000-XX; 13100-XX; or 13150-XX) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to the Docking Station; and 2) when either a

May-01-2014      Hospira Inc.        Abbott Acclaim Infusion Pump – Abbott Acclaim Infusion PumpDesigned to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.               Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks; it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed; the pump cannot be used which canresult in a delay in therapy.

May-01-2014      Hospira Inc.        Hospira Acclaim Encore Infusion Pump – Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.            Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps.  If the door assembly breaks; it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed; the pump cannot be used which canresult in a delay in therapy.

May-08-2014      Alere San Diego; Inc.      INRatio/INRatio2 Test Strips – Alere INRatio2 PT/INR Professional Test Strips; Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use); consisting of the Monitor and test strip; is used for quantitative determination of international normalized ratio (INR) in fresh; capillary whole blood to monitor the effect of warfarin therapy on clotting time by health care professionals. (in vitro diagnostic use).     Test Strips may report an inaccurately low INR result.  Several patients had a therapeutic or near-therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.

May-12-2014      Baxter Corporation Englewood  ABACUS TPN Calculation Software – ABACUS TPN Calculation Software; Product Codes: 8300-0045 ABACUS CE (Calculator Edition); 8300-0046 ABACUS SE (Single-Workstation Edition); 8300-0047 ABACUS ME (Multi-Workstation Edition); 8300-0156 ABACUS 3.0 CE; 8300-0157 ABACUS 3.0 SE; 8300-0158 ABACUS 3.0 ME; 8300-0166 ABACUS 3.1 DE; 8300-0167 ABACUS 3.1 CE; 8300-0168 ABACUS 3.1 SE; 8300-0169 ABACUS 3.1 ME.  ABACUS is a Windows – based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for Total Parenteral Nutrition (TPN) order calculations.          1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders.2. ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premixresulting in an over dilution.3. All software versions of ABACUS software display the calcium phosphate curve points for Premasolincorrectly.4. All software v

May-14-2014      CareFusion 303; Inc.        Alaris Pump model 8100 – Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" FeatureThe Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.              CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used.

May-20-2014      Fisher & Paykel Healthcare; Ltd.                Infant Nasal CPAP – Infant Nasal CPAP (continuous positive airway pressure) Prong; Nasal.CPAP Prongs (10 pack):Model No. BC3020-10; BC3520-10; BC4030-10; BC4540-10; BC5040-10; BC5050-10; BC5550-10; BC5560-10; BC6060-10; BC6070-10; BC6570-10.Bubble CPAP Starter Kits:Model No. BC461-SK; BC471-SK; BC490-SK; BC491-SK; BC492-SK.The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface.         The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.

May-21-2014      Maquet Datascope Corp – Cardiac Assist Division               Datascope System 98/98xt; CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump – Datascope System 98/98xt; CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump.     The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.          Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.

May-22-2014      Fresenius Medical Care Holdings; Inc.     Naturalyte Liquid Bicarbonate Concentrate – Naturalyte Liquid Bicarbonate Concentrate; 6.4 Liter BottlePart Number: 08-4000-LBThe concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates  Naturalyte Liquid Bicarbonate maybe contaminated

May-01-2014      BD Biosciences; Systems & Reagents      Anti EpCam PE – Analyte Specific Reagent Catalog – Anti EpCam PE – Analyte Specific Reagent.Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.  Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled – the actual antibody present in the vial is CD9 PE.

May-01-2014      GE Healthcare; LLC          GE Healthcare Discovery and Optima – GE Healthcare Discovery MR450; Discovery MR750; Optima MR450w; Optima MR450w equipped with the GEM option; Discovery MR750w; and Discovery MR750w equipped with the GEM option products.Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices. GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products.  Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. This could make the safe removal of the patient from the system difficult.

May-01-2014      Teleflex Medical               CAPIO; Monodeck – CAPIO; Monodeck; Violet Monofilament Polydioxanone Suture; 1 x 48 inches (122cm) Absorbable Surgical Suture; Rx Only; Teleflex Medical.   Product Code: 833-137.     The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.

May-01-2014      Teleflex Medical               Dekna-lok – Dekna-lok; 1 x 17.78 cm; Violet Braided Polyglycolic Acid Coated Suture; Synthetic Absorbable Surgical Suture USP; Rx Only; Sterile. Teleflex Product Code: 200101-01.    The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.

May-02-2014      Bio-Rad Laboratories; Inc.            Variant II -thalassemia Short Program Buffers – Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests); Bio-Rad Laboratories; Inc.  in vitro diagnostic.  The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.       There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.

May-02-2014      Stryker Endoscopy          12 Instrument Sterilization Tray – 12-Instrument Sterilization Tray;Product Usage:  The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically; this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The tray features silicon device holders that secure devices during the sterilization process. Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.

May-02-2014      Alere San Diego; Inc.      Cardiac Marker Test – Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems; Model Number 98200; Lot Numbers: 329599; 331265.         The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure); as an aid in the assessment of severity of congestive heart failure; for the risk stratification of patients with acute coronary syndromes; and for the risk stratification of patients with heart failure.     These lots may not recover within range when tested using certain commercially available controls.

May-02-2014      INO Therapeutics (dba Ikaria)     INOmax DSIR Delivery System – INOmax DSIR; model 10007; Nitric Oxide Delivery System; with Software version 3.0.0.  The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2; NO2; and NO; and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.  An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0).  When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module; an intended NO cell failure alarm will occur.  In addition; an unintended NO2 cell failure alarm may also occur.  The NO/NO2 cell failure alarms are caused by an average NO/NO2 circuit concentration greater tha

May-02-2014      Med-Mizer; Inc.               SS Retratabed; Clinical Contour – RetractaBed ; Clinical Contour; Med – Mizer Inc…..  Model SS 762 ( 76 " bed w/ 2 motors);  763 (3 motors); 763 A ( 3 motors; autocontour) 120 V; …Max Safe Working Load 450 LBS.Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.              All configurations of the SS  Retractabed; Clinical Contour;  made prior to June 7 2008 may have had insufficient welding on the foot cross tube.  This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame.  If the weld on the tube breaks; it can lead to bed collapse or the rollers coming out of the channel on th

May-02-2014      Med-Mizer; Inc.               SS Retratabed; Clinical Contour – RetractaBed ; Clinical Contour; Med – Mizer Inc…..  Model SS 801; 802; 803; 803A: 80 " bed with 1; 2; or 3; motors and autocontour120 V; …Max Safe Working Load 450 LBS.Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.              All configurations of the SS  Retractabed; Clinical Contour;  made prior to June 7; 2008 may have had insufficient welding on the foot cross tube.  This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame.  If the weld on the tube breaks; it can lead to bed collapse or the rollers coming out of the channel on t

May-02-2014      Biorep Technologies       Joseph Lamelas Atrial Lift System; Atrial Lift System – Joseph Lamelas Atrial Lift System; Model Number MI-ALS-001.  A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.               The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.

May-02-2014      Med-Mizer; Inc.               SS Retratabed; Clinical Contour – RetractaBed ; Clinical Contour; Med – Mizer Inc…..  Model SS 799; 120 V; …Max Safe Working Load 450 LBS.Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.                All configurations of the SS  Retractabed; Clinical Contour;  made prior to June 7 2008 may have had insufficient welding on the foot cross tube.  This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame.  If the weld on the tube breaks; it can lead to bed collapse or the rollers coming out of the channel on th

May-06-2014      GE Healthcare   Nellcor SpO2 Upgrade kit – Nellcor SpO2 Upgrade kit; consists of a Nellcor SpO2 circuit board; an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device.Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).             Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.

May-06-2014      GE Healthcare   Panda Wall-Mount Infant Warmers; integrated with Nellcor SpO2 – Panda Wall-Mount Infant Warmers; integrated with Nellcor SpO2.Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).             Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.

May-06-2014      Mar Cor Purification        Mar Cor Purification; Central Water Platform (CWP); – Mar Cor Purification; Central Water Platform (CWP);  102; 104 and 106.Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients. Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system; models 102; 104 and 106.  This correction has been initiated due to a potential situation with a specific lot of the water inlet solenoid valve.  The potential exists that the water inlet solenoid valve could cease to function.  If this occurs; CWP will stop producing reverse osmosis water.

May-06-2014      GE Healthcare   Giraffe Infant Warmers integrated with Nellcor SpO2 – Giraffe Infant Warmers integrated with Nellcor SpO2.Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).             Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.

May-06-2014      GE Healthcare   Panda iRes Infant Warmers integrated with Nellcor SpO2 – Panda iRes Infant Warmers integrated with Nellcor SpO2.Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).        Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.

May-06-2014      GE Healthcare   Panda Freestanding Infant Warmers; integrated with Nellcor SpO2 – Panda Freestanding Infant Warmers; integrated with Nellcor SpO2.Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).             Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.

May-06-2014      Bausch & Lomb Inc- Greenville Solutions Plant   Bausch & Lomb; Biotrue – Bausch & Lomb; Biotrue; Multi-purpose contact lens solution; 10 fl.oz.; Sterile.  Out of specification results for one of the two disinfectants.

May-06-2014      AlloSource; Inc. AlloFuse DBM Putty 5cc – AlloFuse DBM Putty 5cc; Catalog No. 90038005AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender.    The donor was hemodiluted.

May-06-2014      Tenex Health Inc              TX1 Tissue Removal System – TX1 Tissue Removal System.  TX1 Procedure Pack P/N 554-1003-001 (outer box); TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue. The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions; in conjunction with mechanical impact.

May-07-2014      Siemens Healthcare Diagnostics; Inc        Siemens Healthcare ADVIA Centaur Folate – Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests)Cat No. 06367974 SMN 10310308 (100 tests)Cat No. 00203473 SMN 10331250 (Ref) (500 tests)Cat No. 09132781 SMN 10340209 (Ref) (2500 tests)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                Serum controls may go out of range low with the ADVIA Centaur Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223

May-07-2014      Teleflex Medical               Bard Fixt Suture Braided Polyester – Bard Fixt Suture Braided Polyester; Rx Only; Teleflex Medical; Research Triangle Park; NC USA Assembled in Mexico.Indicated for use in soft tissue approximation.                Product does not meet minimum needle attachment strength requirements; thus; the needle can become detached from the suture during use.

May-07-2014      Teleflex Medical               Suture; Nonabsorbable; Synthetic; Polyethylene – Teleflex Medical; Research Triangle Park; NC;  Braided Polyester Rx Only; Sterile; Distributed by Boston Scientific; Natick; MA; Tevdek II; Green Braided PTFE Impregnated Polyester Fiber; Nonabsorbable Surgical Suture; USP Sterile; Deknatel; Tevdek II; White Braided PTFE; Impregnated Polyester Fiber; Nonabsorbable Surgical Suture; USP; Sterile; Deknatel; Silky II Polydek White Braided PTFE; Impregnated Polyester Fiber; Nonabsorbable surgical Suture; USP; Sterile; Deknatel; Silky II Polydek; Green Braided PTFE; Impregnated Polyester Fiber; Nonabsorbable Surgical Suture; USP; Sterile; Deknatel; Polylene Green Braided Polyester Suture Nonabsorbable surgical Suture; USP; Deknatel; Bard FIXT Braided Polyester; Green PTFE Rx Only; Teleflex Research Triangle Park; NC USA; Assembled in Mexico.Indicated for use in soft tissue approximation.        Product does not meet minimum needle attachment strength requirements; thus; the needle can become detached from the suture during use.

May-07-2014      Teleflex Medical               Suture; Absorbable; Synthetic; Polyglycolic Acid – Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture; Synthetic Absorbable Surgical Suture; Sterile; Rx Only; Teleflex Medical.Indicated for use in soft tissue approximation.       Product does not meet minimum needle attachment strength requirements; thus; the needle can become detached from the suture during use.

May-07-2014      SpineFrontier; Inc.           SpineFrontier S-Lift Lock Shaft Inserter – SpineFrontier S-Lift Lock Shaft Inserter; an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery.  Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002; Implant Inserter; to aid in securing the implant to the whole implant inserter assembly; SI50000.               It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter; possibly resulting in instrument fragments entering the sterile field:Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal.Pin: The pin used to guide the Lock Shaft Inserter into the ma

May-07-2014      Teleflex Medical               Suture; Nonabsorbable; Synthetic; Polyethylene – Teleflex Medical; Research Triangle Park; NC; Polypropylene;  Rx Only; Sterile; Distributed by Boston Scientific; Natick; MA; CAPIO Green Braided Coated Polyglycolic Acid Suture; Synthetic Absorbable Surgical Suture SUP; RX Only; Teleflex; Deklene II Polypropylene Blue Monofil; Blue Monofilament Polypropylene Suture; Nonabsorbable Surgical Suture USP; Deknatel; Deklene MAXX; Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP; Deknatel.Indicated for use in soft tissue approximation. Product does not meet minimum needle attachment strength requirements; thus; the needle can become detached from the suture during use.

May-07-2014      Teleflex Medical               Deknatel Teleflex Medical Silk Black Braided Silk Suture – Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.                Product does not meet minimum needle attachment strength requirements; thus; the needle can become detached from the suture during use.

May-07-2014      Teleflex Medical               Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture – Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture; Nonabsorbable Surgical Suture; U.S.P.Used for fixation of bone fractures; for bone reconstructions; as a guide pin for insertion of other implants; or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. Product does not meet minimum needle attachment strength requirements; thus; the needle can become detached from the suture during use.

May-07-2014      Teleflex Medical               Nonabsorbable Surgical Suture – Nonabsorbable Surgical Suture; U.S.P.; Sterile – Do Not Resterilize;  Deknatel.Indicated for use in soft tissue approximation.              Product does not meet minimum needle attachment strength requirements; thus; the needle can become detached from the suture during use.

May-08-2014      Medtronic Neuromodulation     SynchroMed II Implantable Drug Infusion Pump – Medtronic SynchroMed II Implantable Drug Infusion Pump; Model 8637-20; 8637-40.The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.            This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose andcan also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk;Medtronic is not re

May-08-2014      Medtronic Neuromodulation     Medtronic Implantable Programmable Infusion Pumps – Refill Kit 8551/856X (includes Models 8561; 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps.Product Usage:  The Refill Kits are intended for use in refilling Medtronic programmable; implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps.     Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps.  There is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks associated with this issue.

May-08-2014      Shimadzu Medical Systems         Shimadzu Digital Radiography X-Ray System; DAR-8000f – Shimadzu Digital Radiography X-Ray System; Catalog No. DAR-8000f.This device is intended to be used for radiography in the hospital with X-ray devices.        Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.

May-09-2014      Medtronic Navigation; Inc.          KIT; 9731427; THORACIC TACTILE PROBES – KIT; 9731427; THORACIC TACTILE PROBES                Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          ADD FUSION NAV AxiEM – ENT PRGM 9734636 ADD FUSION NAV AxiEM                Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          TUBE STERILE O-ARM 20PK – DRAPE 9732722 TUBE STERILE O-ARM 20PK                Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          SHUNT KIT 9733605 NON-INVASIVE – SHUNT KIT 9733605 NON-INVASIVE                Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          TUMOR RES. PACK 9733553 AxiEM S.M. – TUMOR RES. PACK 9733553 AxiEM S.M.       Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          PATIENT TRACKER 9733534XOM ENT 1PK – PATIENT TRACKER 9733534XOM ENT 1PK               Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          SPHERES 8801075 5/TRAY 12PK – SPHERES 8801075 5/TRAY 12PK Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          STRL SPHERE – DISP 9730950 STRL SPHERE; 1 PK INSERT   Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          PIN; 9733235; 100MM; STERILE; PERC REF – PIN; 9733235; 100MM; STERILE; PERC REF             Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Blue Belt Technologies MN          NavioPFSTM System – NavioPFSTM System; Orthopedic Sterotaxic Instrument;  model #’s NPFS-02000; NPFS-02010; NPFS 02020.    Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used during orthopedic knee surgery. One of the electronic modules inside the computer cart assembly may have a defect in one of its components that could result in a latent failure.

May-09-2014      Medtronic Navigation; Inc.          TUMOR RESECTION KIT 9733608 SKULL MOUNT – TUMOR RESECTION KIT 9733608 SKULL MOUNT Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          TUMOR RESECTION KIT 9733607 NON-INVASIVE – TUMOR RESECTION KIT 9733607 NON-INVASIVE               Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT – PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT   Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          SPHERES 8801071 1/TRAY 12PK – SPHERES 8801071 1/TRAY 12PK Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          TRAJ GUIDE KIT; 9733065; BIOPSY; EXT – TRAJ GUIDE KIT; 9733065; BIOPSY; EXT         Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          INSTRUMENT TRACKER 9733533XOM ENT 1PK – INSTRUMENT TRACKER 9733533XOM ENT 1PK    Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          BIOPSY NEEDLE KIT – BIOPSY NEEDLE KIT; 9733068; PASSIVE          Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Nellcor Puritan Bennett Inc. (dba Covidien LP)    Newport Medical Instruments e360 Ventilator – Recalled product is a component of the Newport Medical Instruments e360Ventilator: single board computer; part number SBC2105A.Intended to provide invasive or noninvasive ventilator support and monitoring for infant; pediatric; and adult patients with respiratory failure or respiratory insufficiency.        Reports of the audible alarm not sounding when the ventilator is in an alarm state.  The ventilator; as well as the visual and remote alarms; continue to operate normally.

May-09-2014      Medtronic Navigation; Inc.          TRAJ GUIDE KIT; 9733066; BIOPSY; INT – TRAJ GUIDE KIT; 9733066; BIOPSY; INT         Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          UPGRD PRGM 9734638 ADD AxiEM NAVIGATION – UPGRD PRGM 9734638 ADD AxiEM NAVIGATION             Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          MOUSE 9732721 STERILE O-ARM 10PK – MOUSE 9732721 STERILE O-ARM 10PK      Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          BIT 2.9mm DRILL – BIT 9733516 2.9mm DRILL STERILE        Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          PACK 9731975 TUMOR RESECTION AXIEM CR – PACK 9731975 TUMOR RESECTION AXIEM CR    Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          BAG 9732315 MOUSE STERILE 15 PK – BAG 9732315 MOUSE STERILE 15 PK                Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          STRL SPHERE – DISP 9730951 STRL SPHERE; 5PK INSERT    Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          INST 9731132 KIT CR REF FRAME DRIVER 5PK – INST 9731132 KIT CR REF FRAME DRIVER 5PK         Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      Medtronic Navigation; Inc.          PIN; 9733236; 150MM; STERILE; PERC REF – PIN; 9733236; 150MM; STERILE; PERC REF             Medtronic Navigation is recalling certain Medtronic single-use; disposable devices because there was not sufficient control to assure that returned; unused devices were appropriately examined for product and/or package damage to ensure sterility.

May-09-2014      SCC Soft Computer         SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. – SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results; clinical; and public health laboratories by knowledgeable; trained; and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing; for the purpose of storing; managing; querying; and reporting laboratory data.         When an isolate is resulted without a SNOMED code; isolate information in the downstream system may be incomplete or missing.  As a result; there is the potential for the delay or omission of patient treatment updates.

May-09-2014      William C. Domb; D.M.D.; A Professional Corporation      Enaly 1000 BT-12 Ozone Generator – Enaly 1000 BT-12 Ozone Generator; Model # 1000BT-12The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge. The conversion of oxygen to ozone occurs in a reaction cell excited by a high voltage potential. A control circuit allows the user to manually adjust the ozone output between 40-100% of its rated output.               William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.

May-09-2014      The Anspach Effort; Inc.                REF L-3SD 3 mm Diamond Ball; Standard Length – ANSPACH Cutting bur; 3 mm Diamond Ball; Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone; including the spine and cranium.  Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.

May-09-2014      Codman & Shurtleff; Inc.              MedStream Programmable Infusion Pump – MedStream Programmable Infusion Pump; 20 mL; Product Code: 91-4200The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.         A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.

May-09-2014      Codman & Shurtleff; Inc.              MedStream Programmable Infusion Pump – MedStream Programmable Infusion Pump; 40 mL; Product Code: 91-4201The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.         A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.

May-10-2014      Zimmer; Inc.       DROP LOK" Knee Brace – DROP LOK" Knee Brace***LATEX FREE" Product Usage:Used in the treatment; support; and rehabilitation of many types of knee injuries or following surgical correction.    During a transfer of products from a recently shutdown facility; the firm discovered raw material labeled as latex free actually contained latex.

May-10-2014      Zimmer; Inc.       Tennis Elbow Support – Tennis Elbow Support; Neoprene***LATEX FREE" Product Usage:  Provides compression and warmth for mild to moderate elbow strains and sprains.         During a transfer of products from a recently shutdown facility; the firm discovered raw material labeled as latex free actually contained latex.

May-10-2014      Zimmer; Inc.       Cartilage Knee Brace – Cartilage Knee Brace***LATEX FREE" Product Usage:  Used in the treatment and support of many types of knee injuries or following surgical and nonsurgical correction.  During a transfer of products from a recently shutdown facility; the firm discovered raw material labeled as latex free actually contained latex.

May-10-2014      Zimmer; Inc.       Hinged Knee Support – Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.         During a transfer of products from a recently shutdown facility; the firm discovered raw material labeled as latex free actually contained latex.

May-12-2014      RM Temena GmbH         Ultrasound needles – Ultrasound USB needles; with 30 degree bevel; packaged individually; 10 needles/box;  item number REF USB050-22.   Needles for peripheral nerve blocking under ultrasound guidance              Ultrasound needles may be defective and leak at the needle hub.

May-12-2014      RM Temena GmbH         Ultrasound needles – Ultrasound needles; 22G (0.7 mm) x 50mm; packaged individually; 10 needles/box; item number REF USC050-22.    Needles for peripheral nerve blocking under ultrasound guidance.            Ultrasound needles may be defective and leak at the needle hub.

May-13-2014      Biomet; Inc.        ExploR 7x26mm Modular Radial Stem – ExploR 7x26mm Modular Radial Stem; Catalog number 11-210062.  Elbow prosthesis orthopedic implant.            This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads.  If the wedge ramp threads are missing from the stem; the likelihood of the set screw loosening from the radial stem intraoperatively is increased.  If the set screw loosens; a revision surgery may be necessary.

May-13-2014      Fresenius Medical Care Holdings; Inc.     Revision K  Actuator Test Boards – Revision K  Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K; 2008K2; 2008K@home and 2008T). Part Number: 190713 Revision K                2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump

May-13-2014      Fresenius Medical Care Holdings; Inc.     Fresenius 2008T Hemodialysis Machine – Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and  also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K; 2008K2; 2008K@home and 2008T). Part Number: 190234 Revision K 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump

May-13-2014      Mckesson Medical Immaging     Picture Archive Communication System (PACS) – McKesson Radiology-PACS.McKesson Radiology is a medical image and information application that is intended to receive; transmit; store; retrieve; display; print and process digital medical images; digital medical video; and associated medical information from various medical imaging systems.             High priority alert icon was not displayed in the Study List when there are no Stat studies present.  However; the High priority alert icon is visible when studies marked as Stat priority exist in the Study List.

May-13-2014      Ortho Development Corporation              PS-C Femoral Nonporous Rt Sz 6 – PS-C Femoral Nonporous Rt Sz 6; Model  Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System; for total knee arthroplasty procedures.              A femoral component containing pegs was found in a box for the pegless version.

May-13-2014      Siemens Medical Solutions USA; Inc        Siemens Syngo Dynamics – Syngo Dynamics v9.5 system.  A Picture Archiving and Communication System (PACS) intended for acceptance; transfer; display; storage; archive and manipulation of digital medical images; including quantification and report generation.              Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.

May-13-2014      Siemens Healthcare Diagnostics                ADVIA Centaur XP Immunoassay – ADVIA Centaur XP Immunoassay system; an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 – ADVIA Centaur XP; Catalog # 078-A011R03 – ADVIA Centaur XP refurb.            Instrument Cover Gas Spring failures.  Over time; the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position.  This may lead to the cover falling.

May-13-2014      Medline Industries Inc   Specimen Trap – Mucus Specimen Trap 40 cc; Specimen Trap 40 cc with additional transport cap; Product number  DYND44140 (pack of 50); Product number DYND44140H (individual).    Mucus Specimen Trap 80 cc;  Specimen Trap 80 cc w/ additional transport cap; Product number DYND44180 (pack of 50).  Used to collect mucus specimens during suction of fluid from the oral cavity; nose-throat area and/or bronchi of a patient.       There is a potential that the specified mucus specimen traps are not sterile. Use of the affected products may result in the contamination of patient specimens.

May-13-2014      Roche Diagnostics Operations; Inc.          ACCU-CHEK Compact Plus – ACCU-CHEK Compact Plus Test StripsFor use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip51 count retail strip; 102 count retail strip; 51 count MedBen strip51 count Mail Order strip; Sample Kit 16 per case.The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.        Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood glucose readings in patients undergoing Ceftriaxone therapy. The interference is not described in the product labeling.

May-13-2014      Greatbatch Medical        Coaxial Micro-Introducer Kit – Coaxial Micro-Introducer Kit.  Greatbatch Part Number/Bard Access Systems Order Number/Part Description10636-0018004011Kit Coax 10 Pack 4FR Bard10636-0028005011Kit Coax 10 Pack 5FR Bard10636-0078004012Kit Coax 10 Pack 4FR Bard10636-0088005012Kit Coax 10 Pack 5FR Bard10636-0098004022Kit Coax 10 Pack 5FR Bard10636-0108005022Kit Coax 10 Pack 5FR BardThe Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle; 0.018 inch floppy tip guidewire; and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.  Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.

May-13-2014      Mindray DS USA; Inc. dba Mindray North America            Mindray DS USA Inc. DPM 6 Monitor. – DPM 6 Monitor in use with a Multi Parameter Module (MPM).  Patient monitor used for monitoring; displaying; reviewing; storing; and alarming of multiple physiological parameters including ECG; arrhythmia detection; ST segment analysis; heart rate (HR); respiration rate (RESP); temperature; 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)            The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.

May-14-2014      Baxter Corporation Englewood  RAPIDFILL Syringe Strip – RAPIDFILL Syringe Strip; For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip; White. H93890221 RAPIDFILL Syringe Strip; Yellow. H93890222 RAPIDFILL Syringe Strip; Orange. H93890223 RAPIDFILL Syringe Strip; Red. H93890225 RAPIDFILL Syringe Strip; Blue. H93890227 RAPIDFILL Syringe Strip; Salmon. H93890229 RAPIDFILL Syringe Strip; Violet. H93890231 RAPIDFILL Syringe Strip; Gray. H93890232 RAPIDFILL Syringe Strip; Green.               Sterile 10 ml syringes with twist-off luer sealing tip caps banded together with label material.      Possible breach in sterile barrier for inner and outer bags of theproduct.

May-14-2014      HeartWare Inc   HeartWare Ventricular Assist System – HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) – HeartWare BatteryFor use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings; including transportation via fix-wing aircraft or helicopter.         Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually; that battery should no longer be used and should be replaced.

May-15-2014      InterValve Inc    InterValve V8 Balloon Aortic Valvuloplasty Catheter – InterValve V8 Balloon Aortic Valvuloplasty Catheter; model  172212C110; 192412C110; 212612C110; 232812C110.  Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.       Leak issues were discovered through accelerated age testing.

May-16-2014      Philips Medical Systems; Inc.      IntelliVue Patient Monitoring – Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors.   The monitor is used for monitoring and recording of; and to generate alarms for; multiple physiological parameters.           The risk of battery failure increases with age; when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result in overheating that in rare cases can cause the battery to ignite or explode.

May-16-2014      Hospira Inc.        LARGE BORE Y-IRRIGATION SET – LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; HospiraProduct Usage:For Use With Flexible Irrigation Container Systems           The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01; Latex Free Extension Set; List No. 06543-01; Nonvented Y-Set for Transurethral Resection;  List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01; Large Bore Y-Irrigation Set (Latex-Free); and; List No. 15239-01; 4-Lea

May-16-2014      Hospira Inc.        CYSTOSCOPY/IRRIGATION SET – LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented; 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; HospiraProduct  Usage:For Constant or Intermittent Bladder Irrigation The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01; Latex Free Extension Set; List No. 06543-01; Nonvented Y-Set for Transurethral Resection;  List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01; Large Bore Y-Irrigation Set (Latex-Free); and; List No. 15239-01; 4-Lea

May-16-2014      Hospira Inc.        4-LEAD T-U-R IRRIGATION SET – LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; HospiraProduct Usage:For Transurethral Resection Procedures       The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01; Latex Free Extension Set; List No. 06543-01; Nonvented Y-Set for Transurethral Resection;  List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01; Large Bore Y-Irrigation Set (Latex-Free); and; List No. 15239-01; 4-Lea

May-16-2014      Hospira Inc.        EXTENSION SET; For Bladder Irrigation or Urinary Drainage – LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage; Compatible with T-U-R FLOW-POUCH RESERVOIR; list 6542; 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; HospiraProduct Usage:Bladder irrigation or urinary drainage             The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01; Latex Free Extension Set; List No. 06543-01; Nonvented Y-Set for Transurethral Resection;  List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01; Large Bore Y-Irrigation Set (Latex-Free); and; List No. 15239-01; 4-Lea

May-16-2014      Hospira Inc.        T-U-R Y-Set – LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; HospiraProduct Usage:For use in transurethral resection procedures      The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01; Latex Free Extension Set; List No. 06543-01; Nonvented Y-Set for Transurethral Resection;  List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01; Large Bore Y-Irrigation Set (Latex-Free); and; List No. 15239-01; 4-Lea

May-16-2014      The Anspach Effort; Inc.                Anspach Irrigation Clip 40 – Anspach Irrigation Clip 40Product Usage:  Irrigation clips provide a method of supplying controlled; cooling irrigation during cutting; shaping; and removal of bone; including bones of the skull and spine.   The Irrigation Clips were assembled with the incorrect (smaller) clips.

May-16-2014      Siemens Medical Solutions USA; Inc        syngo Imaging XS – syngo Imaging XSSyngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display; process; read; report; communicate; distribute; store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced postprocessing applications.       A complaint reported that the archiving method at one customer site was changed from implicit to explicit; and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from archive itself.

May-19-2014      Terumo Cardiovascular Systems Corporation      CDI Blood Parameter Monitoring System; CDI 500 Monitor – CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers – 145891; 500AVHCT; Serial Numbers – BPM SN B015552 (installed into CDI 500 Monitor SN 3535)              There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2.  If the Hemoglobin and Hematocrit measurements are not accurate; there is a potential risk of unnecesary blood transfusion with resulting risk of infection or inflammatory reaction.  BPM shipped without meeting manufacturing accep

May-19-2014      Arrow International Inc Arrowgard Blue and Arrowgard Blue – Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter; a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.              The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5  (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however; the kit contains; and should state; Introducer Needle: 18 Ga. x 2.5  (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency; if the clinician were to place the needle under x-r

May-19-2014      SCM True Air Technologies LLC  ECATS E 850 Bariatric Bed – ECATS E 850 Bariatric Bed; True Air Technologies; Inc.         The firm is recalling the products due to lack of design controls; lack of a Device Master Record; and failure to approve specific vendors.

May-19-2014      SCM True Air Technologies LLC  MaXair True Low Air Loss Mattress Replacement System – MaXair True Low Air Loss Mattress Replacement System; True Air Technologies; Inc.          The firm is recalling the products due to lack of design controls; lack of a Device Master Record; and failure to approve specific vendors.

May-19-2014      SCM True Air Technologies LLC  JK Bariatric Beds – JK Bariatric Beds; True Air Technologies; Inc.   The firm is recalling the products due to lack of design controls; lack of a Device Master Record; and failure to approve specific vendors.

May-20-2014      Smith & Nephew Inc      TRIGEN INTERTAN NAIL – TRIGEN INTERTAN NAIL: (1) REF 71675201; 10 MM X 18 CM; 125 degree; (2) REF 71675202; 11.5 MM X 18 CM; 125 degree; (3) REF 71675203; 13 MM X 18 CM; 125 degree; (4) REF 71675204; 10 MM X 20 CM; 125 degree; (5) REF 71675205; 11.5 MM X 20 CM; 125 degree; (6) REF 71675207; 10 MM X 18 CM; 130 degree; (7) REF 71675208; 11.5 MM X 18 CM; 130 degree; (8) REF 71675211; 11.5 MM X 20 CM; 130 degree;  Smith & Nephew; Inc.  Orthopedic fixation device.            A manufacturing error resulted in the set screw being inserted too deep in the affected nails.

May-20-2014      Smith & Nephew Inc      TRIGEN INTERTAN Nail – TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515; 10 MM X 10 CM; 125 degree; LEFT;  (2) REF 71676556; 11.5 MM X 36 CM; 125 degree; RIGHT; (3) REF 71676558; 11.5 MM X 38 CM; 125 degree; RIGHT; (4) REF 71676561; 11.5 MM X 42 CM; 125 degree; LEFT; Smith & Nephew; Inc.      Orthopedic fixation device.                A manufacturing error resulted in the set screw being inserted too deep in the affected nails.

May-20-2014      Siemens Medical Solutions USA; Inc        Siemens MAMMOMAT Inspiration – MAMMOMAT Inspiration.Intended for mammography exams; screening; diagnosis; and stereotactic biopsies under the supervision of medical professionals.   There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk; in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.

May-20-2014      Microline Surgical             Microline Renew Fenestrated Control Tip Grasper – Microline Renew Fenestrated Control Tip Grasper; Single Patient Use; Product Number: 3222The ReNew Fenestrated Grasper Forceps Tips are intended to cut; grasp; and dissect various abdominal tissue for use in endoscopic; including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.    Grasper jaw may break when force is applied to the jaw

May-21-2014      Siemens Medical Solutions USA; Inc        Siemens 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) – 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC)To deliver X-ray radiation for therapeutic treatment of cancer.      Table may lose calibration during patient treatment; which may cause the possibility of mistreatment.

May-21-2014      GE Healthcare; LLC          NeuroMuscular Transmission Module; E-NMT – GE Healthcare; NeuroMuscular Transmission Module; E-NMT-01Product Usage:The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.           When the E-NMT-01 module is used in conjunction with the ElectroSensor; the Neuromuscular Transmission (NMT) values may indicate a deeper level of muscle relaxation than the actual level of muscle relaxation. In the clinical situation visual movements of the hand are seen after TOF (Train of Four) stimulation; but the patient monitor shows no counts; or counts are not corresponding to the actual a

May-21-2014      Philips Healthcare Informatics; Inc.          Philips XRE; the dictation editor system included in the Philips XIRIS 8.1.50 – Philips XRE; the dictation editor system included in the Philips XIRIS 8.1.50XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing; manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.              When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed;  information for the incorrect patient may be displayed

May-21-2014      Ortho-Clinical Diagnostics             VITROS Toal T4 Calibrators – VITROS TT4 CalibratorFor the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems; the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.       Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.

May-21-2014      Gambro Renal Products; Incorporated   Polyflux Revaclear Max; Capillary Dialyzer – Polyflux Revaclear Max; Capillary Dialyzer; Model Number 110634; Gambro Renal Products; Inc.  Intended for the treatment of acute and chronic renal failure by hemodialysis.     The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

May-21-2014      Gambro Renal Products; Incorporated   Polyflux Revaclear; Capillary Dialyzer – Polyflux Revaclear; Capillary Dialyzer; Model Number 110633;Gambro Renal Products; Inc.  Intended for the treatment of acute and chronic renal failure by hemodialysis.              The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

May-21-2014      Siemens Healthcare Diagnostics; Inc.      Dimension Vista CSA and CSAE – Dimension Vista CSA and CSAEThe Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements of CSA are used as an aid in the management of heart; liver and kidney transplant patients. A complaint was received of DimensionVista CSA and CSAE under-recovery of cyclosporine when patient samples are run from theSmall Sample Container. The under-recovery that has been observed is 18 to 44%

May-21-2014      Medline Industries Inc   Esmark Elastic Bandage – Esmark Elastic Bandage (Sterile); 4" x 9′. Item DYNJ05116A; Individually wrapped; 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient’s body. It is also used as a tourniquet to restrict blood flow to a part of a patient’s body.  This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.

May-21-2014      Fujifilm Medical System USA; Inc.             The MXR-35 X-ray Generator’s. – MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation.x-ray generator           The MXR-35 X-ray Generator’s labeling did not include the certification statement as required by 21 CFR Part 10 10.2.

May-22-2014      Smiths Medical ASD; Inc.              SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket – SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket;  used with the Equator Convective Warmer; are intended for thermal regulation of a patient’s temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures.      The hose could separate from the blanket.

May-23-2014      Siemens Healthcare Diagnostics; Inc        ADVIA Centaur Systems VitD  500 test; Ready Pack – ADVIA Centaur Systems VitD  500 test; Ready Pack; Catalog Number: 10631021.Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.              Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra; Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

May-23-2014      Siemens Healthcare Diagnostics; Inc        Siemens Healthcare – ADVIA Centaur Systems TSH3 Ultra ; Ready Pack; 500 testCatalog Number: 06491080; Siemens Material Number: 10282379.Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.    Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra; Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

May-23-2014      Siemens Healthcare Diagnostics; Inc        ADVIA Centaur Systems TSH3 Ultra – ADVIA Centaur Systems TSH3 Ultra 2500 testsCatalog Number: 04862625; Siemens Material Number (SMN) : 10361944.Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.       Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra; Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

May-23-2014      Physio-Control; Inc.        Physio Control LIFEPAK 1000 Defibrillator – LIFEPAK 1000 defibrillator.The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.        Physio-Control has become aware of incidents where customers have attempted to use theirLIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery.A defibrillator in this scenario has the potential to fail to deliver a shock; with the potential resultthat therapy is not delivered and a patient is not resuscitated.  A software malfunction in the LIFEPAK 100

May-23-2014      Siemens Healthcare Diagnostics; Inc        ADVIA Centaur Systems VitD Total 100 test; Ready Pack – ADVIA Centaur Systems VitD Total 100 test; Ready Pack; For OUS; SMN 10699201.Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.    Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra; Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

May-23-2014      Siemens Healthcare Diagnostics; Inc        ADVIA Centaur Systems VitD 100 test; Ready Pack – ADVIA Centaur Systems VitD 100 test; Ready Pack; Catalog Number: 10491994.Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.              Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra; Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

May-23-2014      Siemens Healthcare Diagnostics; Inc        ADVIA Centaur Systems BRAHMS PCT 100 test – ADVIA Centaur Systems BRAHMS PCT 100 testSold only OUS; Catalog Number: 10378883.            Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra; Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

May-23-2014      Siemens Healthcare Diagnostics; Inc        ADVIA Centaur Systems TSH3 Ultra Ready Pack – ADVIA Centaur Systems TSH3 Ultra Ready Pack; 100 testCatalog Number:  06491072; Siemens Material Number: 10282378.Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.            Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra; Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

May-23-2014      Heraeus Kulzer; LLC.       Gluma Desensitizer Power Gel – Gluma Desensitizer Power GelProduct Usage:  Usage:This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.           The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at atime. If extruded all at once; product could reach the dental patients mucosa; face or eyes or the dental professional could be exposed. This would cause irritation; burning or blistering.

May-23-2014      Siemens Medical Solutions USA; Inc        Siemens Linear Accelerator (LINAC) – Siemens Linear Accelerator (LINAC) models. Product Usage:deliver X-ray radiation for therapeutic treatment of cancer         Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not been validated as being compatible with Siemens LINAC models.

May-24-2014      Medtronic Inc. Cardiac Rhythm Disease Management    Medtronic Temporary Pacemaker Model 5348 – Medtronic Temporary Pacemaker; model 5348.  Single Chamber Temporary Pacemaker (AAI/VVI).  Intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment.The device is typically connected to temporary transvenous; epicardial or myocardial pacing leads; in a bipolar configuration; using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (MedtronicModel 5832 or 5832S).     Due to the development of high resistance on internal electrical connector contacts due to oxidation over time; events related to a pacing rate outside of the intended setting; including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm); have been reported.

May-27-2014      Beaver-Visitec International Inc.               Visitec Anterior Chamber Cannula – Visitec Anterior Chamber Cannula; .40x22mm (27Gx7/8in)REF 585006Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye; and remove materials where appropriate. These products are used in all sections of the eye. This cannula is a general use cannula mainly designed for the precise maintenance of optimum anterior chamber depth                Mislabeled: Visitec Anterior Chamber cannula27G  contains a sharp tip needle when the product should contain a blunt tip cannula

May-27-2014      Siemens Medical Solutions USA; Inc        Siemens MAGNETOM Aera magnetic resonance system – MAGNETOM Aera magnetic resonance system.Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse; sagittal; coronal and oblique cross sectional images; spectroscopic images and/or spectra; and that displays the internal structure and/or function of the head; body; or extremities.             Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.

May-27-2014      AGFA Corp.        IMPAX CV Pediatric Echo Reporting; IMPAX CV Echo Measurement Import via Optical Character Recognitio – IMPAX CV Pediatric Echo Reporting; IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX.The IMPAX CV Reporting component facilitates the quick effective creation of digital structured reports for adult catheterization and echocardiography; pediatric echocardiography; congenital heart disease; nuclear cardiology and non-invasive vascular disease management.        Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.

May-28-2014      Siemens Medical Solutions USA; Inc.       ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); – ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35);The SC2000 ultrasound imaging system is intended for the following applications: Cardiac; Neo-natal and Fetal Cardiac; Pediatric; Transespohageal; Adult Cephalic; Peripheral Vessel; Abdominal; Abdominal Intraoperative; Intraoperative Neurological; Musculo-skeletal Conventional; and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications.       Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) –  may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted; the system does not restart the pulsed wave Doppler or continuous wave Doppler waveform.

May-28-2014      Siemens Medical Solutions USA; Inc.       ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) – ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature.The SC2000 ultrasound imaging system is intended for the following applications: Cardiac; Neo-natal and Fetal Cardiac; Pediatric; Transespohageal; Adult Cephalic; Peripheral Vessel; Abdominal; Abdominal Intraoperative; Intraoperative Neurological; Musculo-skeletal Conventional; and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications;Transcranial Imaging Applications.      Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35)  when using the stress echo feature which could cause the need for the study to be repeated.

May-28-2014      GE Healthcare   Centricity PACS  Workstation – The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional; including radiologists; physicians; technologists; clinicians; and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display; manipulate; archive; print; and export images when connected wit the Centricity PACS infrastructure.  It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed study; images for the previously displayed study may also be rejected. The issue can occur with a previously displayed study that remains open in the background. If one or more; but not all; images in

May-28-2014      B. Braun Medical; Inc.    Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer – Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with IntroducerSpinal injection of anesthetics to provide regional anesthesia                B.Braun Medical; Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.

May-29-2014      Synthes; Inc.      Synthes – Synthes ProDisc-C 2.0mm Milling Bit-Sterile;  Synthes 2.0mm Milling Bit HXC Sterile; Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft-Sterile; and Synthes 2.0mm Milling Bit with Flat Coupling-Sterile.Product Usage: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the vertebral bodies. The milling bits are coupled to a power tool and interface with the milling guide; which is connected to a trial implant for the keel preparation step.  Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.

May-29-2014      Abbott Laboratories       ARCHITECT Intact PTH Calibrators – ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300.Product Usage:The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.                Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT In

May-29-2014      Abbott Laboratories       ARCHITECT Intact PTH Control – ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300.Product Usage:The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.        Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT In

May-29-2014      Abbott Laboratories       ARCHITECT Intact PTH Assay – ARCHITECT Intact PTH Reagent Kit (8K25) consists of: 1 Bottle (6.6 mL) Anti-PTH (goat; polyclonal) coated microparticles in TRIS buffer with a preservative of sodium azide; 1 Bottle (5.9 mL) Anti-PTH (goat; polyclonal) acridinium-labeled conjugate in MES buffer with protein (bovine; goat) stabilizer with a preservative of sodium azide; and; 1 Bottle (10.0 mL) Intact PTH Assay Diluent containing phosphate buffer with protein (bovine; goat) stabilizer with a preservative of sodium azide.Product Usage:The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.              Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT In

May-30-2014      Bayer Corp          Medrad – Medrad Continuum MR Infusion system- non-wireless systemThe MEDRAD Continuum MR Infusion System is 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. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff; primarily critical care; emergency room and radiology nursing staff.                There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008.

May-30-2014      CryoLife; Inc.      BioGlue Surgical Adhesive (BioGlue) – BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta; femoral; and carotid arteries).                Serum albumin component monomer failed to meet internally established end of shelf-life specification.

May-30-2014      Integra LifeSciences Corp.            Integra Licox Test Kit – Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor’s PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific electrical signal to the monitor.              Integra LifeSciences has identified through a small number of complaints that some lot numbers of Licox Test Kits (Catalog Number BC10R) may provide erroneous "calibration test failure" message when they are used with the Licox PtO2 Monitor (LCSO2; or may provide an erroneous out of range result with the Licox CMP Brain Tissue Oxygen and Temperature Monitor (AC31).

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