Class I recalls

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

Bryan Medical Inc            Jul-08-2013         Tracoe Mini 3.0mm tracheostomy tube. – Tracoe Mini 3.0mm Tube; for pediatric use.Pediatric tracheostomy tube used to provide safe airway access.     The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.

Medtronic MiniMed       Jul-09-2013         Medtronic MiniMed Paradigm Insulin Infusion Sets – Medtronic MiniMed Paradigm Insulin Infusion SetsThe Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.         Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets.  Under certain conditions; the infusion set may malfunction and deliver an incorrect volume of insulin.

Codman & Shurtleff; Inc.              Jul-16-2013         MedStream Programmable Infusion Pump – MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or MorphineProduct Code:91-4200 (20ml pump) US 91-4200.Intended for the intrathecal delivery of Baclofen or Morphine.       Miscalibrated Fill Level Sensor may affect dosing level

Codman & Shurtleff; Inc.              Jul-16-2013         MedStream Programmable Infusion Pump – MedStream Programmable Infusion Pump ; Implantable for the intrathecal delivery of Baclofen or MorphineProduct Code:91-4201US (40ml pump)91-4201 (40ml pump)Intended for the intrathecal delivery of Baclofen or Morphine.              Miscalibrated Fill Level Sensor may affect dosing level

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – AlboGraft Knitted with Collagen; Straight 40x08Catalog Number: AMC4008AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.          Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – AlboGraft Knitted with Collagen; Straight 60x06Catalog Number: AMC6006AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.          Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – AlboGraft Knitted with Collagen; Straight 60x08Catalog Number: AMC6008AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.          Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – AlboGraft Woven with Collagen; Straight 15x26Catalog Number: ATC1526AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.                Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – AlboGraft Woven with Collagen; Straight 15x30Catalog Number: ATC1530AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.                Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – AlboGraft Woven with Collagen; Straight 30x16Catalog Number: ATC3016AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.                Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – AlboGraft Woven with Collagen; Straight 30x18Catalog Number: ATC3018AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.                Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – AlboGraft Woven with Collagen; Straight 30x24Catalog Number: ATC3024AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.                Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – AlboGraft Woven with Collagen; Straight 30x26Catalog Number: ATC3026AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.                Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – AlboGraft Knitted with Collagen; Straight 40x07Catalog Number: AMC4007AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.          Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – AlboGraft Knitted with Collagen; Bifurcate 20x10Catalog Number: AMC2010AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.          Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – AlboGraft Knitted with Collagen; Bifurcate 18x10Catalog Number: AMC1810AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.          Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – AlboGraft Knitted with Collagen; Bifurcate 18x09Catalog Number: AMC1809AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.          Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – Albo Graft Knitted with Collagen; Bifurcate 16x08Catalog Number: AMC1608AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.          Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         AlboGraft Knitted with Collagen – AlboGraft Knitted with Collagen; Straight 15x06Catalog Number:  AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.               Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         AlboGraft Knitted with Collagen – AlboGraft Knitted with Collagen; Bifurcate 14x08Catalog Number: AMC1408AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Blood blushing/leaking from the surface of the graft after implantation

LeMaitre Vascular; Inc.  Jul-22-2013         LeMaitre Albograft – AlboGraft Knitted with Collagen; Straight 60x07Catalog Number: AMC6007AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.          Blood blushing/leaking from the surface of the graft after implantation

GE Healthcare; LLC          Jul-24-2013         VG Hawkeye – GE Healthcare Varicam/VG and VG Hawkeye devicesProduct Usage:The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body; using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology; Cardiology; Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static; Multi-gated; Dynamic; Whole body scanning) and tomographic (SPECT; Gated SPECT; Whole body SPECT; Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators; gating by physiological signals; real-time automatic body contouring; and CT-based attenuation correction and functional anatomic mapping.      GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.

GE Healthcare; LLC          Jul-24-2013         Infinia – GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera; Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems).  Nuclear Medicine Systems Infinia devices Product Usage:  The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body; using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology; Cardiology; Neurology and other clinical diagnostic imaging applications.          GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.

GE Healthcare; LLC          Jul-24-2013         Brivo NM615 – Brivo NM615; is an all-purpose; single detector integrated nuclear imaging system.  Product Usage:  The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment; patient and equipment supports; and accessories.             GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.  UPDATE:  On July 03; 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

GE Healthcare; LLC          Jul-24-2013         Discovery NM630 – Discovery NM 630; dual detector free-geometry integrated nuclear imaging system.  Product Usage:  The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting; localizing; diagnosing of diseases and in assessment of organ function for the evaluation of diseases; trauma; abnormalities; and disorders such as; but not limited to; cardiovascular disease; neurological disorders and cancer.  The system output can also be used by the physician for staging and restaging of tumors; planning; guiding; and monitoring therapy.  The GE Discovery NM 630 system is a Nuclear Medicine (NM) system; which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body; using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static; Multi-gated; Dynamic and Whole body scanning) and tomographic mode (SPECT; Gated SPECT; Whole body SPECT).  The acquisition types include single and multi-isotope/ multi peak frame/list mode single-photon imaging.  The imaging-enhancement features include assortment of collimators; gating by physiological signals; and real-time automatic body contouring.  The GE Discovery NM 630 system may include signal analysis and display equipment; patient and equipment supports; components and accessories.  The system may be used for patients of all ages. GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.  UPDATE:  On July 03; 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

GE Healthcare; LLC          Jul-24-2013         Optima NM/CT 640 – Optima NM/CT 640  Product Usage:  The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.  It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types; and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies               GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.  UPDATE:  On July 03; 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

GE Healthcare; LLC          Jul-24-2013         Discovery NM/CT 670 – Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system.   Product Usage:  The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting; localizing; diagnosing of diseases and organ function for the evaluation of diseases; trauma; abnormalities; and disorders such as; but not limited to; cardiovascular disease; neurological disorders and cancer.  The system output can also be used by the physician for staging and restaging of tumors; planning; guiding; and monitoring therapy.         GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.  UPDATE:  On July 03; 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

GE Healthcare; LLC          Jul-24-2013         Helix – Elscint APEX Helix; dual-head; multi-purpose; Slip-Ring; digital gamma camera Product Usage:The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body; using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology; Cardiology; Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static; Multi-gated; Dynamic; Whole body scanning) and tomographic (SPECT; Gated SPECT; Whole body SPECT; Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators; gating by physiological signals; real-time automatic body contouring; and CT-based attenuation correction and functional anatomic mapping.               GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.

Class II recalls

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

Zimmer; Inc.       Jul-01-2013         Bigliani/Flatow¿ – Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.              This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included.  Zimmer; Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery.                                    

Zimmer; Inc.       Jul-01-2013         Bigliani/Flatow¿ – Bigliani/Flatow¿ The Complete Solution Fukuda Retractors  Small Nonsterile 00-4305-019-30.Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.       This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included.  Zimmer; Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery.                                    

Linvatec Corp. dba ConMed Linvatec      Jul-01-2013         GENESYS Cross FT Suture Anchor with Two #2 (5 metric) HI-FI Sutures – GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures         Incorrect blue/white suture was used.                                     

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         ConMed Linvatec Spectrum II and Arthrex SutureLasso – – ConMed Linvatec Spectrum II Suture Hook Crescent; Medium (Teal) 4.0 x 20.0mm.  REF C6386  Lot 122592.- Arthrex SutureLasso SD; 25 Degree Tight Curve Left; Wire Loop; (Green) 1.8mm.  REF AR-4068-25TL  Lot 122518 and Lot 123190.– Arthrex SutureLasso SD; 25 Degree Tight Curve Right; w/Nitinol Wire Loop; (Lt. Green) 1.8mm.  REF AR-4068-25TR  Lot 122518 and Lot 123190.- Arthrex SutureLasso  SD; 90 Degrees (Black) 1.8mm. REF AR-4068-90 Lot 122504.- Arthrex SutureLasso; 45 Degree; Perforating Needle Cannula; w/Suture Loop; (Lt. Grey).  REF AR-4065S  Lot 122590.-SutureLasso; w/Wire Loop; 90 Degree; (Blue) REF AR-4065-90W Lot 123263.Manual surgical instrument for general use             The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                     

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         Instratek Carpal Tunnel Release Blades – -Instratek Carpal Tunnel Release Blades; (1) Triangle Blade; (1) Hook Blade. REF R2056 – LOT 122279-Instratek Carpal Tunnel Release Hook Blade.  REF 2055 Lot 122669 -Linvatec CTS Relief Kit.  REF 9971; lot 122504-Biomet Indiana Tome Blade for Carpal Tunnel Release (White). REF 200060.  Lot 122504 and Lot 123190.-KMI SafeGuard Knife; For SafeGuard Mini Carpal Tunnel Release System; (White).  REF 08-0003.  Lot # 122609Surgical Knife            The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                   

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         GII QuickAnchor Plus – GII QuickAnchor Plus; ETHIBOND Polyester Suture; 36"; double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266General and Plastic Surgery         The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                     

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         Scorpion and SureFire Scorpion – -Scorpion Needle; For Use With Scorpion Suture Passer; (Blue). Ref. AR-13990N Lot 123263-SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279-Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.              The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                           

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         CAPSure; Coblator; CoVAC; ArthroWand; Microblastor; Saber; Saphyre; SERFAS; TriStar; VARP; Vulcan. – -90 Degree L-Hook Tip Arthroscopic Electrode; for use with 7205440 Switchpen; (Blue) 170mm. Ref. 7205441 Lot 122502-Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288-CAPSure 30 ArthroWand; CW; 30 Degree Shaft Angle; (Grey) 3.0mm. Ref. AC 1830-01 Lot 122494-Coblator II Evac 70 Xtra Plasma Wand; w/Integrated Saline Line & Integrated Cable. Ref. EIC 5872-01 Lot 122295; 122308; 122626; 122325; -Coblator II; ENT ReFlex Ultra 45 w/Integrated Cable; (Blue). Ref. EIC 4845-01 Lot 122651; 122419; 122671; 122633Electrosurgical cutting and coagulation device and accessories.-CoVac 50; Suction ArthroWand; w/Integrated Cable; (White/Grey). Ref. ASC 2530-01 Lot 122483; 122745-CoVac 70; ICW ArthroWand 70 angle 3.0mm. Ref. ASC 3730-01 Lot 122483; -Eliminator; Right Angle ArthroWand (Beige). Ref. A 1345-01 Lot 122446-Eliminator; Right Angle ArthroWand; 90 Degree w/Integrated Cable; (Grey) 4.5mm. Ref. AC 1345-01 Lot 122494; 122446-ENT Coblator II PROcise XP Wand; w/Integrated Cable; Suction & Saline; (Blue). Ref. EIC 8872-01 Lot 122651; 122762-Ligament Chisel Probe;Curved w/Integrated Cable; (Grey/Green). Ref. 7209647 Lot 122512-LightWave Suction Ablator; 90 Degree; Hand Control; Multi-Angle; (Blue/White) 4.5mm x 142mm. Ref. IA-2000-S Lot 122512-Lo-Pro 90 Degree ArthroWand; w/Integrated Cable; (Grey) 3.6mm. Ref. AC1336-01 Lot 122654; 122325-Meniscectomy Electrode; Standard Design (Grey) 165mm. Ref. C5010A Lot 122765-MeniVac ArthroWand w/Suction; w/Integrated Cable; (Grey) 3.0mm. Ref. ASC 5500-01 Lot 122630; 122494-Microblastor 30 Wand; 30 Degree; w/Integrated Cable; (Grey) 0.9mm Tip. Ref. AC 40500-01 Lot 122293-Right Angle ArthroWand; 90 Degree; w/Integrated Cable; (Grey) 3.5mm. Ref. AC 1340-01 Lot 123044; 122673-Saber 30 ArthroWand; 30 Degree; w/Integrated Cable; (Grey) 3.0mm. Ref. AC 4330-01 Lot 122630; 122494; 123044; 122283; 122765-SAPHYRE II Bipolar Ablation Probe; w/suction; High Profile 50 Degree; (Pewter). Ref. 7210112 Lot 122734-SERFAS ENERGY Hook Probe 3.5mm. Ref. 279-350-501 Lot 123266-Small Joint ArthroWand; Short Bevel 35; w/Integrated Cable; Suction (Grey/White) 2.3mm. Ref. AC 2823-01 Lot 122494; 122663-StarVac ArthroWand; Short Bevel 35; w/Integrated Cable; Suction (Grey)5.5mm. Ref. ASC 4251-01 Lot 122630; 122593; 122483; 123044; 122283; 122595-Super MultiVac 50; 50 Degree; w/Suction and Integrated Cable; (Grey/Black) 3.0mm. Ref. ASC 4830-01 Lot 122029; 123044; 122663-Super TurboVac 90; 90 Degree Suction ArthroWand; (White/Grey) 3.5mm. Ref. ASC 4250-01 Lot 122029;122654; 122651; 122427; 122630; 122494; 122626; 122745; 122293; 122663; 122325; 122765-TAC-C II Probe; w/Integrated Cable; (Blue/Grey). Ref. 7209628 Lot 122486-TriStar 50 Suction ArthroWand; 50 Degree w/Integrated Cable; (White/Grey). Ref. ASC 4630-01 Lot 122283-Turbinate; Tissue Coagulating Electrode; (White). Ref. 1120-4110-01 Lot 122486-VAPR Hook Electrode W/Integrated Handpiece 3.5mm. Ref. 227305 Lot 122288; 122466-VAPR LD; Suction Electrode; Large Diameter (Blue) 4.0mm. Ref. 225360 Lot 122512-VAPR Premiere50-; w/Integrated Cable; Suction; (Black/White) 3.0mm. Ref. 227504 Lot 122029; 122455-VAPR Premiere90 w/Suction tion; Integrated Cable; (Black/White) 3.3mm. Ref. 227204 Lot 122029; 122446; 122466; 122306; 122435; 122293; -VAPR S90 Suction Electrode; w/Integrated Cable; (Black/White). Ref. 225370 Lot 122577; 122455; 122593; 122288; 122466; 122589; 122356; 122639; 122325; 122318-VAPR Side Effect Electrode (Blue) 3.5mm. Ref. 225301 Lot 122512-VAPR Side Effect Electrode; w/Integrated Handpiece 3.5mm. Ref. 227301 Lot 122288; 122356; -VAPR Wedge Electrode (Short;) w/Integrated Cable (Black/White) 2.3mm x 85 mm. Ref. 227213 Lot 122409-VAPR Wedge Electrode; w/Integrated Cable (Black/White) 2.3mm. Ref. 227203 Lot 122486; 122639-VAPR Angled; Side Effect Electrode (Blue) 3.5mm. Ref. 225302 Lot 122512-Vulcan Sa           The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                   

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         Re-New II Endocut Scissor Tip; – – Re-New II Endocut Scissor Tip; 16.51mm  5.0mm Ref. 3142 Lot 122295; 122308; 122455; 122875Manual surgical instrument for general use.  The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                     

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         Hall MicroChoice – – Average Medium Blade  9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590; 122447- Cannulated Drill Bit; Quick Coupling; For 3.5 & 4mm Cannulated Screws; 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lot 122289- Hall MicroChoice; Oscillating Blade; Fine; Flat; Stainless Steel 5.5mm x 12.0mm x 0.4mm Ref. 5023-160 Lot 123353- Hall MicroChoice; Oscillating Saw Blade; Fine; Flat; Stainless Steel 5.5mm x 18.5mm x 0.4mm Ref. 5023-162 Lot 123353- Hall MicroChoice; Sagittal Saw Blade; Fine  4.5mm x 25.5mm x 0.4mm Ref. 5023-139 Lot 122454- Hall MicroChoice; Sagittal Saw Blade; Stainless Steel 9.5mm x 25.5mm x 0.4mm Ref. 5023-138 Lot 122454; 123353- Large Sagittal Saw Blade  25mm x 89.5mm x 0.89mm Ref. 2108-102 Lot 122490- Micro Choice Oscillating Saw Blade  5.5mm x 18.5mm x 0.40mm Ref. KM-3000 Lot 122440- Micro Oscillating and Sagittal Saw Blade  9.0mm x 25mm x 0.51mm Ref. 2296-33-521 Lot 122609; 122429- Oscillating and Sagittal Saw Blade  9.0mm x 31mm x 0.51mm Ref. 2296-33-225 Lot 122347 – Oscillating Sagittal  Blade  9mm x 31mm x .38mm Ref. 2296-3-525 Lot 123263- Oscillating Saw Blade  9.0mm x 25.0mm x .38mm Ref. SP-511 Lot 122631- Oscillating Saw Blade  9mm x 25mm x .38mm Ref. 2296-3-511 Lot 122447- Reciprocating Saw Blade; Double Sided Fixed Point Travel: 3.56mm 70mm x 12.5mm x 0.64mm Ref. 227-96-275 Lot 122490- Round Fast Cutting Stainless Steel Bur; 8 Flute 4.8mm Ref. 1608-6-139 Lot 122447- Sagittal Saw Blade  4.5mm x 25.4mm Ref. KM-3102 Lot 122465- Small Oscillating Blade  9.0mm x 31.0mm x .4mm Ref. 2296-3-125 Lot 122447- Small Oscillating Saw Blade  5.5mm x 11.5mm x 0.38mm Ref. 2296-3-410 Lot 122429- Small Oscillating Saw Blade  5.5mm x 18.0mm x  0.4mm Ref. 2296-3-212 Lot 122511- Small Oscillating Saw Blade  5.5mm x 18mm x 0.38mm Ref. 2296-3-412 Lot 122447- Small Oscillating Saw Blade  7mm x 18.5mm x 0.38mm Ref. 2296-3-114 Lot 122429; 122511- Small Oscillating Saw Blade  9.0mm x 31mm x 0.4mm Ref. 2296-3-225 Lot 122590; 122447- Small Sagittal Saw Blade; Fine Tooth 9.5mm x 25.5mm x 0.4mm Ref. ZS-338 Lot 122647- System 4 & System 2000 Sagittal Saw Blade  12.5mm x 81.5mm x 1.19mm Ref. 2108-152 Lot 122490- System 4; System 2000 & EHD Sagittal Saw Blade; Dual Cut 1.27mm x 11mm x 90mm Ref. 4111-127-090 Lot 123263- System 4; System 2000 & EHD Sagittal Saw Blade; Dual Cut 18mm x 75mm x 0.89mm Ref. 4118-089-075 Lot 123263- System 4; System 2000 & EHD Sagittal Saw Blade; Dual Cut 25mm x 90mm x 1.27mm Ref. 4125-127-090 Lot 122347- System 4; System 2000 & EHD Sagittal Saw Blade; Dual-Cut 18mm x 90mm x 1.35mm Ref. 4118-135-090 Lot 122347Surgical instrument motors and accessories/attachments             The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                      

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         Acorn Bur; – – Acorn Bur; Long; For Use With TPS Universal Drill; Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665- Cannulated Drill Bit; for 3.0mm Cannulated Screws; 1.2mm Cannulation; Quick Coupling 2.0mm x 150mm Ref. 310.221 Lot 122289- Drill Bit; For Modular Hand System; Quick Coupling 2.8mm x 165mm Ref. 310.288 Lot 122322- Drill Bit; Quick Coupling (Gold) 2.5mm Ref. DB-2.5 Lot 122289; 122322- Egg Micro  Bur; 10 Flute; Stainless Steel  4.0mm Ref. 1608-2-35 Lot 122429; 122347- Hall Micro Bur; Oval; Long; 8-Flute; Carbide 4.0mm x 8.0mm Ref. 5092-136 Lot 123353- Micro Bur; Round; Stainless Steel  3.2mm Ref. 1608-2-11 Lot 122447; 122347- Oval Bur; Fast Cutting; 8-Flutes; Carbide; 44.5mm Total Length; 18.6mm Exposure 4.0mm x 7.9mm Ref. 227-10-62 Lot 122411- Oval Bur; Solid; 8-Flute; Medium; Head Length: 7.7mm; Carbide 4.0mm x 48mm Ref. 5300-10-901 Lot 122647- Oval Cutting Carbide Bur; Medium; (8-Flute) 4.0mm Ref. 5091-136 Lot 123353; 122454- Round Bur; Medium; Solid 8-Flute; Carbide 4.0mm x 48.3mm Ref. 5300-10-511 Lot 122665- Round Bur; Micro; 8-Flute; Exposure: 28.2mm Stainless Steel 2.4mm x 54mm Ref. 1608-2-9 Lot 122447- Twist Drill; Quick Coupling 110mm 2.5mm Ref. 310.25 Lot 122289; 122322- Wire Pass Drill Bit  1.5mm Ref. 1608-2-59 Lot 122511Surgical instrument motors and accessories/attachments The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                    

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         Barron Radial Vacuum Trephine – Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336Opthalmic        The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                   

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         Abrader; AcromioBlaster; CoolCut; Dyonics; Elite; Formula; Gator; Great White; Incisor; RazorCut; Sy – – Abrader Bur; Round (Aqua) 4.0mm Ref. 7205324 Lot 123270- AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590; 122454; 122465; 122434; 122665- AcromioBlaster Burr (Sage Green) 4.0mm Ref. 7205668 Lot 122590; 123270- Acromionizer Bur; Barrel; (Mauve) 4.0mm Ref. 7205326 Lot 122609- BoneCutter Blade; Full Radius; Series 3000 (Orange/Black) 5.5mm Ref. 7206010 Lot 122609- CoolCut Bone Cutter (Blue/Orange) 3.8mm Ref. AR-8380BC Lot 122631arthoscope- CoolCut Bone Cutter (Blue/Orange) 4.0mm Ref. AR-8400BC Lot 122631- CoolCut Bone Cutter (Blue/Orange) 5.5mm Ref. AR-8550BC Lot 122631- CoolCut Dissector (Blue/Blue) 3.5mm Ref. AR-8350DS Lot 123190- CoolCut Dissector (Blue/Blue) 4.0mm Ref. AR-8400DS Lot 123190; 122493; 122631- CoolCut Dissector (Blue/Blue) 5.0mm Ref. AR-8500DS Lot 122493- CoolCut Dissector Small Joint (Blue/Blue) 3.0mm Ref. AR-7300DS Lot 123190; 122493; 122631; – CoolCut Excalibur (Blue/Beige) 3.8mm Ref. AR-8380EX Lot 122631- CoolCut Excalibur (Blue/Beige) 4.0mm Ref. AR-8400EX Lot 122631- CoolCut Oval Burr (12 Flutes) (Blue/White) 5.5mm Ref. AR-8550OBT Lot 122631- CoolCut Oval Burr (8 Flute) (Blue/White) 4.0mm Ref. AR-8400OBE Lot 122493; 122631; 122279- CoolCut Oval Burr (8 Flute) (Blue/White) 5.0mm Ref. AR-8500OBE Lot 122493- CoolCut Round Burr (8 Flute) (Blue/Red) 5.0mm Ref. AR-8500RBE Lot 123190- CoolCut Sabre (Blue/Green) 3.8mm Ref. AR-8380SR Lot 122493- DYONICS ELITE Achromobacter (Sage Green) 4.0mm Ref. 72200730 Lot 122665- Elite* AcromioBlaster Burr (Brick Red/Yellow) 5.5mm Ref. 72200731 Lot 122665- Formula Aggressive Plus Cutter (Beige/Blue) 5.5mm Ref. 375-564-000 Lot 122309- Formula Aggressive Plus Cutter (Dk. Blue/Lt. Blue) 5.0mm Ref. 375-554-000 Lot 122490- Formula Aggressive Plus Cutter (Yellow/Blue) 3.5mm Ref. 375-534-000 Lot 122518; 122309- Formula Aggressive Plus Cutter Large Hub; (Red/Blue) 4.0mm Ref. 375-544-000 Lot 122594; 122588; 122518; 122278- Formula Barrel Bur; 12-Flute (Beige/Beige) 5.5mm Ref. 375-951-012 Lot 122278- Formula Barrel Bur; 12-Flute (Blue/Blue) 5.0mm Ref. 375-951-112 Lot 122594- Formula Barrel Bur; 12-Flute (Red/Red) 4.0mm Ref. 375-941-012 Lot 122594; 122518- Formula Barrel Bur; 6-Flute (Beige/Beige) 5.5mm Ref. 375-951-000 Lot 122588- Formula Barrel Bur; 6-Flute (Red/Red) 4.0mm Ref. 375-941-000 Lot 122588- Formula Full Radius Cutter; Small Joint; (Grey) 2.5mm Ref. 375-627-000 Lot 122594- Formula Hooded Abrasion Bur; Small Joint; (Orange) 3.0mm Ref. 375-647-000 Lot 122518- Formula Resector Cutter (Red/Black) 4.0mm Ref. 375-542-000 Lot 122588- Formula Resector Cutter (Yellow/Black) 3.5mm Ref. 375-532-000 Lot 122594; 122490; 122588- Formula Round Bur; 12-Flute (Beige/Beige) 5.5mm Ref. 375-950-012 Lot 122278- Formula Round Bur; 12-Flute (Red/Red) 4.0mm Ref. 375-940-012 Lot 122594- Formula Round Bur; 6-Flute (Blue/Blue) 5.0mm Ref. 375-950-100 Lot 122490- Formula Round Bur; 6-Flute (Red/Red) 4.0mm Ref. 375-940-000 Lot 122518- Formula Slotted Whisker (Red/Red) 4.0mm Ref. 375-548-000 Lot 122594- Formula Tomcat Cutter (Red/White) 4.0mm Ref. 375-545-000 Lot 122588- Formula Tomcat Cutter (Yellow/White) 3.5mm Ref. 375-535-000 Lot 122588- Full Radius Blade (Yellow) 4.5mm Ref. 7205306 Lot 122347; 122454; 122609; 123270; 122665- Full Radius Blade; (Beige) 3.5mm Ref. 7205305 Lot 122609; 122665- Full Radius Blade; (Orange) 5.5mm Ref. 7205307 Lot 122665- Full Radius ELITE Blade (Beige) 3.5mm Ref. 7210751 Lot 122465; 122665- Full Radius Mini Blade; 7cm Length (Red) 2.9mm Ref. 3419 Lot 122609- Full Radius Resector Large Hub; Sterling; Shaver; (Yellow) 4.2mm Ref. 9247A Lot 123263; 122592; 123353- Full Radius Resector; Large Hub; Merlin; Pre-Bent 15 Degree; (Yellow/Black) 4.2mm Ref. C9241 Lot 123263- Full Radius Resector; Sterling; Large Hub; (Yellow) 3.5mm Ref. C9248 Lot 123263; 122592; 122511- Gator B                The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                            

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         Large Tear Cross Cut Rasp – Large Tear Cross Cut Rasp  14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument for general use    The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                   

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         Midas Rex – – Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511- Drill Bit; Straight Shank  2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322- Drill Bit; w/Depth Mark; Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347- Fast Cutting Drill Bit  2.0mm Ref. FDB 2.0 Lot 122289; 122322- Midas Rex Metal Cutting Drill Bit  3.0mm x 18.3mm Ref. MC30 Lot 122347Orthopedic manual surgical instrument             The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                     

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         IDEAL 30 Suture Grasper (Green) 30 Degree – – IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511- IDEAL 60 Suture Grasper (Pink) 60 Degree Ref. 251723 Lot 122631Passer     The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         TPS Micro Reciprocating Small Tear Cross Cut Rasp – TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518; 122447.  Orthopedic manual surgical instrument         The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                        

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         SCD Express; Vaso-Force; Benaflow – – Calf Garment  Standard Ref. L501-M Lot 122549; 122985- Calf Garment; DVT10  Standard Ref. DVT10 Lot 122570; 12546- Calf Garment; DVT20  Large Ref. DVT20 Lot 122549; 122570- SCD Express Compression Sleeve; Knee Length; (White) Large Ref. 9789 Lot 122574- SCD Express Compression Sleeve; Knee Length; (White) Medium Ref. 9529 Lot 122547; 122574- SCD Express Compression Sleeve; Thigh Length; (White) Medium Ref. 9530 Lot 122574Compressible limb sleeve. – Thigh Garment DVT30  Medium Ref. DVT30 Lot 122549; 122985- Thigh Garment DVT40  Large Ref. DVT40 Lot 122549; 122985- Vaso-Force Intermittent DVT Calf Garment; Large; Calf Sizes up to 24" 24" Ref. MDS601L Lot 122982; 122986- Vaso-Force Intermittent DVT Calf Garment; Medium; Calf Sizes up to 18" 18" Ref. MDS601M Lot 122986; 122984- VENAFLOW Calf Cuff; w/Foam (White) 19" Max. Calf Circumference Ref. 3010-PL Lot 122692; 122715     The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                         

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         Relieva Flex – – Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429- Relieva Luma Sentry 20 Tip Angle; 0.035 Diameter 100cm Ref. SIS100B Lot 122429Manual surgical instrument for general use           The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                    

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         ACCU-PASS; ENDO-SCRUB; Spectrum – – ACCU-PASS Suture Shuttle; 70 Degree; Upbend; (Orange) Ref. 72200419 Lot 122504- Carpal Tunnel Release Blade Assembly; (White)  Ref. 81010 Lot 123263; 122406; 122482; 123043; 122518; 122511- ENDO-SCRUB 2; (1) Sheath; 0 Degree; For K. Storz; Medtronic Sharpsite AC; (Green) 4.0mm Ref. 19-12000 Lot 122289- Spectrum II Disposable Suture Hook 45 degree; Right (RED) Ref. C6380 Lot 122592Orthopedic manual surgical instrument.              The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                   

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         – CLEAR-TRAC COMPLETE; Threaded Cannula with Obturator – – CLEAR-TRAC COMPLETE; Threaded Cannula with Obturator; (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631; 122609- CLEAR-TRAC Flexible Cannula System Threaded; w/Obturator; (Lime Green) 8.0mm x 72mm Ref.             The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                    

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         Turbosonics Mini-Flared ABS Tip – – Turbosonics Mini-Flared ABS Tip; 45 Degree OZil 12 Degree; (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215- TurboSonics¿ Mini-Flared ABS¿ Tip; 20 Degree Tip Angle; 45¿ Kelman; (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590; 123372- TurboSonics¿ Tapered ABS¿ MicroTip" 30¿ Kelman; (Purple/Silver) 0.9mm Ref. 8065750263 Lot 122309Series 20000" Legacy¿ TurboSonics¿ Flared ABS MicroTip; 30 Degree; Kelman; (Pink) 0.9mm Ref. 8065740839 Lot. 122309Phacofragmentation system.           The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                     

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         ENDOPATH Resposable Bladeless Trocar; Non-Handled; w/Housing; – – ENDOPATH Resposable Bladeless Trocar; Non-Handled; w/Housing; 100mm; (Green) 10/11mm Ref. 511NA Lot 123215; 122647- ENDOPATH Resposable Bladeless Trocar; Non-Handled; w/Housing; 100mm; (Orange) 5.0mm Ref. 35LNA Lot 123215; 122647- ENDOPATH Resposable Trocar w/Dilating Tip Obturator & Housing; 100mm; (Orange) 5mm Ref. 35LDA Lot 122647- ENDOPATH Resposable Trocar; Dilating Tip w/Housing; 100mm; (Purple) 10/12mm Ref. 512DA Lot 123215- ENDOPATH Sleeve Housing (Orange) 5mm Ref. 355HR Lot 123215; 122647Endoscope and accessories – ENDOPATH Trocar; Disposable Sleeve Housing; (Green) 10/11mm Ref. 511HR Lot 122647- ENDOPATH Blunt Tip Obturator & Housing; w/Olive Plug; 100mm; (Purple) 10/12mm Ref. 512BA Lot 122647- ENDOPATH Resposable Trocar w/ Dilating Tip Obturator & Housing; 100mm; (Green) 10/11mm Ref. 511DA Lot 122454; 122647- ENDOPATH; Bladeless Trocar with Stability Sleeve; Non-handled 10/12mm Ref. 512NT Lot 123254- ENDOPATH Xcel Bladeless Trocar; Handled; w/Stability Sleeve; (Teal) 11mm x 100mm Ref. 811LTH Lot 122300- ENDOPATH Xcel Bladeless Trocar; w/Stability Sleeve 12mm x 150mm Ref. B12XT Lot 122300- ENDOPATH Xcel Bladeless Trocar; w/Stability Sleeve 5.0mm x 150mm Ref. B5XT Lot 122429- ENDOPATH Xcel Bladeless Trocar; w/Stability Sleeve; (Teal) 11mm x 100mm Ref. B11LT Lot 122454; 123254; 122429- ENDOPATH Xcel Bladeless Trocar; w/Stability Sleeve; 100mm Length 5.0mm Ref. B5LT Lot 122347; 122454; 122592; 122490; 123254; 122429; 122300- ENDOPATH Xcel Bladeless Trocar; w/Stability Sleeve; 75mm Length; (Teal) 5.0mm Ref. B5ST Lot 123254- ENDOPATH Xcel Blunt Tip Trocar; w/Smooth Sleeve & Adjustable Plug;  (Purple) 12mm x 100mm Ref. H12LP Lot 122338; 122372; 123254; 123215- ENDOPATH Xcel Dilating Tip Trocar; w/Stability Sleeve; (Gold) 11mm x 100mm Ref. D11LT Lot 122454- ENDOPATH Xcel Dilating Tip Trocar; w/Stability Sleeve; (Gold) 12mm x 100mm Ref. D12LT Lot 122454- ENDOPATH Xcel Dilating Tip Trocar; w/Stability Sleeve; (Gold) 5.0mm x 100mm Ref. D5LT Lot 122338; 122454; 122490; 122429- ENDOPATH Xcel Integrated Stability Trocar Sleeve 11mm x 100mm Ref. CB11LT Lot 122429- ENDOPATH Xcel Integrated Stability Trocar Sleeve 12mm x 100mm Ref. CB12LT Lot 122490- ENDOPATH Xcel Integrated Stability Trocar Sleeve 5.0mm x 100mm Ref. CB5LT Lot 122490; 122429; 122300- Kii Optical Access System  Threaded (Blue) 5mm x 100mm Ref. C0Q04 Lot 122609         The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                           

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         Harmonic ACE Ergonomically-Enhanced Curved Shear; Pistol Grip; Hand Controlled; – Harmonic ACE Ergonomically-Enhanced Curved Shear; Pistol Grip; Hand Controlled; (White) 5.0mm x 36cm Ref. ACE36E Lot 122295; 122308; 122762Unclassified         The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                   

Surgical Instrument Service And Savings; Inc.      Jul-01-2013         ENDOPATH; Ligaclip MCA; Proximate Plus; and TX Stapler – -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter; (Blue) w/o Staples 35mm. REF ATB35 Lot 122300.-Ligaclip MCA Multiple Clip Applier; 20 Small Clips Small.  REF MCS20 Lot 122300.- Ethicon Pistol Grip; Fixed Head Skin Stapler; Multi-Directional Release; (Grey) 35W.  REF PXW35  Lot 122309 and Lot 123263.-Proximate Linear Cutter; w/o Staples 75mm.  REF TLC75 Lot 122490-Ethicon Proximate Plus MD; Skin Stapler Regular.  REF PMR35 Lot 122753.-Proximate Plus; Rotating Head; Skin Stapler (White) Wide.  REF PRW35 Lot 122406.- Ethicon PROXIMATE PLUS; Skin Stapler; Pistol Grip; Fixed Head; Multi-Directional Release; (Grey) Regular.  REF PXR35  Lot 122675 and Lot 123263.-TX Reloadable Linear Stapler 3.5mm Leg; w/o Staples 60mm. Ref. TX60B Lot 122490Manual surgical instrument for general use               The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.                                   

Maquet Cardiovascular Us Sales; Llc        Jul-01-2013         MAQUET YUNO OTN Mobile Operating Table and Extension Device – MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05.The YUNO OTN is used to support and position patients for surgical procedures immediately before; during and after the surgical phase. The table top is radio translucent and enables intraoperative use of X-ray equipment.               MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) and will make enhancements to the YUNO table (part number 1433.01F0).Identification of the Extension device issue:  By fully actuating the lever of the extension device handle; the operator’s skin can enter a gap between the handle lever and a recess in the handle bar.  When the lever is released;                                   

Ortho-Clinical Diagnostics             Jul-02-2013         ORTHO Assay Software (OAS) Server – ORTHO¿ Assay Software (OAS) Server; Catalog # 6842840Usage:The ORTHO¿ Summit System (OSS) is a modular; integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local area network; assay-specific pipetting protocols and ORTHO Assay Software (OAS); OSS automates many of the processing functions and data management requirements associated with ELISA (enzyme-linked immunosorbent assay) microplate testing.    There is evidence that an electrical short within the systems connector has caused an accumulation of  heat which has radiated back through the wiring harness causing the wires and connectors to melt.                                   

Ortho-Clinical Diagnostics             Jul-02-2013         VITROS 3600 Immunodiagnostic System – VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative; semi-quantitative; and qualitative measurement of a variety of analytes of clinical interest; using VITROS Immunodiagnostic Products Reagents     There is evidence that an electrical short within the systems connector has caused an accumulation of  heat which has radiated back through the wiring harness causing the wires and connectors to melt.                                   

Ortho-Clinical Diagnostics             Jul-02-2013         VITROS 5600 Integrated System – VITROS 5600 Integrated System (product code 6802413) Product Usage:  For use in the in vitro quantitative; semi-quantitative; and qualitative measurement of a variety of analytes of clinical interest; using VITROS Chemistry Products Slides; VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.     There is evidence that an electrical short within the systems connector has caused an accumulation of  heat which has radiated back through the wiring harness causing the wires and connectors to melt.                                       

Ortho-Clinical Diagnostics             Jul-02-2013         VITROS 4600 Chemistry System – VITROS 4600 Chemistry System (VITROS 5;1 FS System family member)(product code 6802445) Product Usage:  For use in the in vitro quantitative measurement of a variety of analytes of clinical interest; using both VITROS Chemistry Products Slides (colorimetric endpoint; rate; ion-selective electrode; and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)                There is evidence that an electrical short within the systems connector has caused an accumulation of  heat which has radiated back through the wiring harness causing the wires and connectors to melt.                                           

Ortho-Clinical Diagnostics             Jul-02-2013         VITROS 5;1 FS Chemistry System – 1) VITROS 5;1 FS Chemistry System (product code 6801375) and  2) VITROS 5;1 FS Chemistry System Refurbished (product code 6801890)Product Usage:  For use in the in vitro quantitative; semi-quantitative; and qualitative measurement of a variety of analytes of clinical interest; using VITROS Chemistry Products Slides; VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.         There is evidence that an electrical short within the systems connector has caused an accumulation of  heat which has radiated back through the wiring harness causing the wires and connectors to melt.                                 

Philips Medical Systems (Cleveland) Inc Jul-02-2013         Brilliance CT 64; Ingenuity Core; and Ingenuity Core128 scanner – Computed Tomography X-ray systems Product Usage:  The Brilliance CT 64; Ingenuity Core; and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment; patient; and equipment supports; components and accessories.             Philips Healthcare received reports from the field that certain Brilliance CT 64; Ingenuity Core; and Ingenuity Core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images; which may impair the diagnostic quality of affected images.                                       

The Anspach Effort; Inc.                Jul-02-2013         Emax Consoles – ***REF SC2100***eMax 2 Plus Console***SN G 10307653002***Product Usage:The RPM of the Motor Handpiece may be less than 80;000 RPM (approximately 72;000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50;000 to 70;000 RPM.           The RPM of the Motor Handpiece may be less than 80;000 RPM.                                      

The Anspach Effort; Inc.                Jul-02-2013         Emax Consoles – ***REF SC2102***eMax 2 Plus Console; Single Port; no Irrigation***SN G16307882402***Product Usage:The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than 80;000 RPM (approximately 72;000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50;000 to 70;000 RPM).   The RPM of the Motor Handpiece may be less than 80;000 RPM.                                              

The Anspach Effort; Inc.                Jul-02-2013         Emax Consoles – ***REF SC2101***eMax 2 Plus Console; Single Port; with Irrigation***SN G17307901802***Product Usage:The RPM of the Motor Handpiece may be less than 80;000 RPM (approximately 72;000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50;000 to 70;000 RPM.     The RPM of the Motor Handpiece may be less than 80;000 RPM.                                              

Penlon; Ltd.        Jul-02-2013         Penlon Sigma Delta Vaporizer – Delta VaporizerAn anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.  It has come to Penlon Ltd’s attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the vaporizer.  Penlon Ltd has updated the Installation and daily Pre-Use Check sections of the User Manual to ensure that the instructions are explicit and clear.                                           

BRAEMAR; INC.                Jul-02-2013         Lithium Thionyl non-rechargeable disposable battery pack – Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.   Braemar Inc.;  became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor.  The event did not result in any patient related injury or present any clinical impact.                                       

BRAEMAR; INC.                Jul-02-2013         Lithium Thionyl non-rechargeable disposable battery pack – Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder.Non-rechargeable disposable battery pack.   Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. The event did not result in any patient related injury or present any clinical impact.                                              

Clorox Healthcare Holdings; LLC (dba HealthLink)              Jul-02-2013         HealthLink***BIOPSY PUNCHES – HealthLink***BIOPSY PUNCHES***Disposable manual instrument for skin biopsy.          Due to lack of sterilization.                                          

Clorox Healthcare Holdings; LLC (dba HealthLink)              Jul-02-2013         PSS Select medical products***Biopsy Punches – PSS Select medical products***Biopsy Punches***Disposable manual instrument for skin biopsy.           Due to lack of sterilization.                                      

Clorox Healthcare Holdings; LLC (dba HealthLink)              Jul-02-2013         ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** – ARGENT SURGICAL SYSTEMS***BIOPSY Punches***Disposable manual instrument for skin biopsy.           Due to lack of sterilization.                                   

Siemens Medical Solutions USA;  Inc       Jul-03-2013         Siemens MEVATRON series; PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems – Siemens MEVATRON series; PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability.The intended use of the SIEMENS branded MEVATRON"; ARTISTE"; ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.             The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this issue  may have resulted in mistreatment of patients.                                   

DJO; LLC               Jul-03-2013         AIRCAST VENAFLOW ELITE SYSTEM – VenaFlow Elite 30B-B and 30BI-BProduct Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.           DJO; LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire).                                    

Merit Medical Systems; Inc.        Jul-03-2013         Custom Procedural Trays – Custom Procedural Trays: Merit’s Custom Angio KitsA 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. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.                Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of the sterility of this accessory.                                    

SpineFrontier; Inc.           Jul-05-2013         InSpan Inserter – InSpan Inserter; Right Assembly; InSpan Inserter; Left AssemblyProduct Usage:Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.             Potential for set screw to be come deformed.                                  

SpineFrontier; Inc.           Jul-05-2013         S-LIFT – BASE; S-LIFT Instrument Case Product Usage:System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.          The S-LIFT Instrument Case contained a bracket with peeling nylon coating.                                        

SpineFrontier; Inc.           Jul-05-2013         S-LIFT – S-LIFT Inserter Outer Sleeve Product Usage:The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA                The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.                                  

Cardio Medical Products               Jul-08-2013         Cardio Medical Products Inc. – Cardio Medical Products; Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use OnlyManufactured for Cardio Medical Products 385 Franklin Avenue; Suite L Rockaway; New Jersey 07866www.cardiomedicalproducts.com(800) 227-3633 (973) 586-9624 FAXDefibrillator   Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.                                            

Boston Scientific Corporation     Jul-09-2013         NephroMax high Pressure Nephrostomy Balloon Catheter. – NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140; M062101440/210144Dilation of the nephrostomy tract.  Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.                                  

Boston Scientific Corporation     Jul-09-2013         NephroMax high Pressure nephrostomy Balloon Catheter Kit. – NephroMax high Pressure nephrostomy Balloon Catheter Kit.  Material Number/Catalog Number:  M0062101600/210-160; M0062101640/210-164Dilation of the nephrostomy tract.              Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.                                         

Abbott Medical Optics; Inc.         Jul-09-2013         Sovereign¿ Compact Phacoemulsification System – Sovereign¿ Compact Phacoemulsification System; v 5.3; Part Number: CMP680300. The system is used for cataract surgery.   Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory Notice to all customers who use the AMO Sovereign? Compact Phacoemulsification System; Version 5.3; because it has the potential to lose the vacuum tone mode during surgery.                                         

Toshiba American Medical Systems Inc  Jul-10-2013         TOSHIBA Kalare X-Ray System – TOSHIBA Kalare Diagnostic X-Ray System K110785               Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down; the large focus is also heated after a few seconds or more. This occurs when the Automatic Exposure Function (AEC) function is used. As a result; a radiographic tube current exceeding the set value flows and a brighter image than expected is acquired.                                               

Angiodynamics; INC        Jul-10-2013         RITA Main Cable – AngioDynamics RITA Main Cable; 9 Pin to 14 Pin; REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.     The RITA Main Cable product contains the incorrect Instructions for Use.                                           

Zimmer; Inc.       Jul-10-2013         Bigliani/Flatow¿ The Complete Shoulder Solution – Bigliani/Flatow¿ The Complete Shoulder Solution; Humeral Stem Provisional 12mm x 170mmThis reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip; knee; shoulder; ankle; elbow). It can be made of metal or plastic.               The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17; lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices.                                   

Baxter Healthcare Corp.                Jul-10-2013         Four Lead TUR Irrigation Set; UROMATIC Plastic Contaners. – Four Lead TUR irrigation Set; for use with UROMATIC Plastic Containers;  Product Code 2C4013 – Approximate Length 85" (2.2. m)Usage:Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy; transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers. A firm’s internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.                                               

Baxter Healthcare Corp.                Jul-10-2013         Four Lead Arthroscopic irrigation Set; for use with ARTROMATIC Plastic Containers. – Four Lead Arthroscopic Irrigation Set; for use with ARTHROMATIC Plastic Containers; Product Code 2C4031 -Approximate Length 99" (2.5. m)Usage:Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy; transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers.  A firm’s internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.                                      

Baxter Healthcare Corp.                Jul-10-2013         Two Lead TUR Irrigation Set – Two Lead Arthroscopic Irrigation Set; for use with ARTHROMATIC Plastic Containers; Product Code 2C4030 – Approximate Length 98" (2.5. m)Usage:Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy; transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers.              A firm’s internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.                                     

Baxter Healthcare Corp.                Jul-10-2013         FOLFUSOR SV Elastomeric Infusion Devices – Baxter’s elastomeric infusion pumps are non-electronic; ambulatory; disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion.The infusion pumps can be utilized for slow; continuous delivery through clinically acceptable routes of administration such as intravenous (IV); intra-arterial (IA); and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.     There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled; primed; re-capped (using the blue winged Luer cap) and stored for a period of time; typically overnight. In addition; the reported instances of leakage                                            

Baxter Healthcare Corp.                Jul-10-2013         INFUSOR SV Elastomeric Infusion Devices – Baxter’s elastomeric infusion pumps are non-electronic; ambulatory; disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion.The infusion pumps can be utilized for slow; continuous delivery through clinically acceptable routes of administration such as intravenous (IV); intra-arterial (IA); and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.     There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled; primed; re-capped (using the blue winged Luer cap) and stored for a period of time; typically overnight. In addition; the reported instances of leakage                                            

Baxter Healthcare Corp.                Jul-10-2013         INFUSOR LV Elastomeric Infusion Devices – Baxter’s elastomeric infusion pumps are non-electronic; ambulatory; disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion.The infusion pumps can be utilized for slow; continuous delivery through clinically acceptable routes of administration such as intravenous (IV); intra-arterial (IA); and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.     There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled; primed; re-capped (using the blue winged Luer cap) and stored for a period of time; typically overnight. In addition; the reported instances of leakage                                            

Linvatec Corp. dba ConMed Linvatec      Jul-10-2013         APEX Arthroscopy Tubing Set – ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set.Intended for use for joint irrigation and dissention during arthroscopic procedures.        Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set; One Connection and C7122 APEX Arthroscopy Tubing Set; Two Connection; contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site.                                               

Linvatec Corp. dba ConMed Linvatec      Jul-10-2013         APEX Arthroscopy Tubing Set – ***REF C7120***APEX Arthroscopy Tubing Set.Intended for use for joint irrigation and dissention during arthroscopic procedures.  Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set; One Connection and C7122 APEX Arthroscopy Tubing Set; Two Connection; contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site.                                      

Fresenius Medical Care Holdings; Inc.     Jul-10-2013         Fresenius – Fresenius Liberty Cycler Set Single Conn./Ext DLProduct  Number: 050-87216Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.       Cassette may leak during set up or during peritoneal dialysis treatment                                

Integra LifeSciences Corp.            Jul-11-2013         Integra Hallu-Fix cannulated screw driver and cannulated screwdriver tip – Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND).Indicated for use in fixation of fractures; osteotomies and arthrodesis of the first metatarso-phalangeal joint.     The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.                                               

SagaTech Electronics; Inc.             Jul-11-2013         Remmers (formerly SnoreSat) – Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder)To be used to gather heart rate and blood oxygen data during a sleep study.              The outer jacket is receding away from the black sensor prematurely.                                           

Siemens Medical Solutions USA; Inc        Jul-11-2013         Siemens Mammomat Inspiration – Siemens Mammomat Inspiration –  full-field digital mammographyProduct Usage:  Mammography              Firm became aware of an unintended behavior when using the Mammomat Inspiration.  The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted.  Although the possibility is rare; the system could move while a patient’s breast is compressed resulting in a possible bruise.  Firm released Update Instructions XP031/12/S for this iss                                 

Intuitive Surgical; Inc.     Jul-11-2013         da Vinci Dual Camera Controller – da Vinci Dual Camera Controller; model number DC3000;Manufactured by Intuitive Surgical; Sunnyvale; CA 94086.Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.       Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.                                     

Intuitive Surgical; Inc.     Jul-11-2013         da Vinci Si Vision System Cart – da Vinci Si Vision System Cart; model number VS3000;Manufactured by Intuitive Surgical; Sunnyvale; CA 94086.Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.       Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.                                     

Intuitive Surgical; Inc.     Jul-11-2013         da Vinci Si Surgeon Side Cart – da Vinci Si Surgeon Side Cart; model number SS3000;Manufactured by Intuitive Surgical; Sunnyvale; CA 94086.Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.       Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.                                     

Intuitive Surgical; Inc.     Jul-11-2013         da Vinci Instrument Control Box – da Vinci Instrument Control Box; model number ICB3000;Manufactured by Intuitive Surgical; Sunnyvale; CA 94086.Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.     Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.                                      

Fresenius Medical Care Holdings; Inc.     Jul-11-2013         Fresenius – Fresenius Service Replacement 0-Ring.  Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines; models 2008K; 2008K2; 2008K@Home and 2008T             Incorrect rubber nitrile O-rings distributed  instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)                                 

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154211 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize B7 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154214 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize C3 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154215 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize C4 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154216 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize C5 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154217 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize C6 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154218 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize C7 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154221 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize D3 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154222 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize D4 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.  The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154223 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize D5 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.  The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154224 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize D6 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.  The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154225Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize D7 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.  The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154228 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize E3 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154229 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize E4 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154230 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize E5 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154231Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize E6 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154232 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize E7 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154235Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize F3 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154236 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize F4 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154237 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize F5 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154238 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize F6 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154239 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize F7 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.  The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154210 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize 6ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154209 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize B5 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154208 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize B4 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154207 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize B3 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154204 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize A7 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154203 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize A6 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154202 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize A5 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154201 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize A4 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

Biomet; Inc.        Jul-11-2013         Oxford Fixed Bearing Partial Knee Replacement – REF 154200 Oxford Fixed Bearing Partial KneeCemented Lateral TibiaSize A3 ARCOM UHMWPE / CO-CR-MO AlloyOnly for use in Lateral compartmentSterile RThe Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.  Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.                                       

DeRoyal Industries Inc   Jul-11-2013         ORTHO TOTAL JOINT TRACECART(R) – GEO-MED ORTHO TOTAL JOINT TRACECART(R); REF 53-1831.07; Rx Only; NON-STERILEProduct Usage:  general surgical   DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization.                                       

Roche Diagnostics Operations; Inc.          Jul-12-2013         ELECSYS ¿-CrossLaps/Serum Immunoassay – B-CrossLaps/serum (B-CTx in serum)REF 11972308 160 100 testsImmunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring antiresorptive therapies (e.g. bisphosphonates; hormone replacement therapy – HRT) in postmenopausal women and individuals diagnosed with osteopenia. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.        Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the sample stability given in the Elecsys ?-CrossLaps (?-CL) assay package insert version 5; could not be reproduced.  The ?-CrossLaps test results contribute to the monitoring of antiresorptive therapy. False low or false normal results may lead to delayed diagnosis and treatment of osteoporosi                                   

Synthes USA HQ; Inc.     Jul-12-2013         Synthes Craniomaxillofacial (CMF) Distraction System – Synthes CMF Distraction SystemThe product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus; where gradual bone distraction is required. It is intended for single use only.          The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF)  Distractor System; due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates.                                  

KooJoo Trading Company             Jul-13-2013         Odyssey – Safety Lancets – Odyssey; Button Activated;Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts;  No lancing device required.26G – Single Use Only; Made In KoreaDistributed by Hummingbird Medical; Savannah; GA100 count Boxes; 40 boxes per caseBlood collection by penetrating skin with needle.    Lancets were not sterilized within the dose range established by sterilization validation.                                               

Karl Storz Endoscopy America Inc             Jul-13-2013         27023WU Balloon Catheter – 27023WU Balloon Catheter; 3 Fr.; 2/pkg; sterile; contains latex.  The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.   Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised; and therefore the sterility of the product could be affected.                                      

Terumo Cardiovascular Systems Corporation      Jul-13-2013         CDI 500 Monitor – CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe.Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH; PCO2; PO2; K+; oxygen saturation; hematocrit; hemoglobin; and temperature are desired.         Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.                                              

Terumo Cardiovascular Systems Corporation      Jul-13-2013         CDI 500 Monitor – CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH; PCO2; PO2; K+; oxygen saturation; hematocrit; hemoglobin; and temperature are desired.                Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.                                       

Terumo Cardiovascular Systems Corporation      Jul-13-2013         CDI 500 Monitor – CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe.Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH; PCO2; PO2; K+; oxygen saturation; hematocrit; hemoglobin; and temperature are desired.                Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.                                       

Terumo Cardiovascular Systems Corporation      Jul-13-2013         CDI 500 Monitor – CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module.Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH; PCO2; PO2; K+; oxygen saturation; hematocrit; hemoglobin; and temperature are desired.               Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.                                      

Terumo Cardiovascular Systems Corporation      Jul-13-2013         CDI 500 Monitor – CDI Blood Parameter Monitoring System 500 with Venous blood parameter module.Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH; PCO2; PO2; K+; oxygen saturation; hematocrit; hemoglobin; and temperature are desired.               Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.                                      

Paa Laboratories Inc       Jul-15-2013         GE Healthcare/PAA Healthcare – Various types of Fetal Bovine SerumBovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.     Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Nativeare pure Fetal Bovine Serum (FBS). These products may contain added adult Bovine SerumAlbumin (BSA)of United States origin; water; and/or cell growth promoting additives. All otherFBS products; as listed below; including FBS Gold and FBS Standard; described as specialtysera’; may contain adult BSA of Un                                        

Integra LifeSciences Corporation              Jul-16-2013         PANTA Arthrodesis Nail Support Device – Integra PANTA Arthrodesis Nail System.Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.          As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail Support Device; Integra has decided to issue this voluntary medical device correction.  The misalignment can result in the inability to properly insert the screws into the Panta Nail and create the potential need for revision surgery.                                               

Stryker Instruments Div. of Stryker Corporation                Jul-16-2013         TPS Universal Driver – Stryker TPS Universal Driver REF 5100- 99 Rx ;The Stryker Total Performance System (TPS) is intended for use in the cutting; drilling; reaming; decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT; dental orthopedic; maxillofacial; spinal; and plastic surgery. The instruments are also used in the placement of screws; wires; pins; and other fixation devices.          The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software.  Handpieces that have been programmed with the incorrect parameters could result in unintended activation.  There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100                                       

Stryker Instruments Div. of Stryker Corporation                Jul-16-2013         REMB Universal Driver – RemB  Electric Universal Driver REF 6400-099-000  For use with the CORE and TPS System sRx OnlyThe RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories; the RemB Electric Universal Driver is intended for surgical procedures involving driving wire or pins into bone and hard tissue. This includes but is not limited to Dental; ENT (Ear; Nose; Throat); Neuro; and Endoscopic applications. This device can also be used with the Total Performance System (TPSTM).   The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software.  Handpieces that have been programmed with the incorrect parameters could result in unintended activation.  There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100                                       

Stryker Instruments Div. of Stryker Corporation                Jul-16-2013         CORE Universal Driver – CORE Universal Driver REF 5400- 99 Rx OnlyThis drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting; drilling; reaming; decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT; dental orthopedic; maxillofacial; spinal; and plastic surgery. The instruments are also used in the placement of screws; wires; pins; and other fixation devices.    The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software.  Handpieces that have been programmed with the incorrect parameters could result in unintended activation.  There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100                                    

SpineFrontier; Inc.           Jul-16-2013         Rods – Pedicle screw spinal system – KRD1 PedFuse Rods; Model:  IM80100-13 Rev BProduct Usage:  Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.             One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.                                               

St. Jude Medical               Jul-16-2013         Eon Mini Charging System – Eon Mini – 3721 (Charger).  Product Usage:Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome; intractable low back and leg pain.       St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator.  In three cases; patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30; 2012; St. Jude Medica                                            

St. Jude Medical               Jul-16-2013         Eon Charging System – Eon – 3701 (Wall Charger) and 3711 (Portable Charger).  Product Usage:Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome; intractable low back and leg pain. Eon Mini: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome; intractable low back and leg pain.    St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator.  In three cases; patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30; 2012; St. Jude Medica                                 

Zeiss; Carl Inc     Jul-17-2013         Polarizer D Fixed w/Rotating Red 1 lambda plate – Polarizer D Fixed w/Rotating Red 1 lambda plate.Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.              Carl Zeiss Microscopy; LLC is recalling the Polarizer D component used in All upright ZEISS microscopes (Axio Imager; Axio Scope.A1; Axio Lab.A1) due to Misaligned Full-Wave (Lambda) Plate.                                          

Staar Surgical Co.              Jul-17-2013         STAAR Surgical nanoFLEX IOL – nanoFLEX CC4204A Intraocular LensCorrect aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis. STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.                                             

Staar Surgical Co.              Jul-17-2013         STAAR Surgical Afinity IOL – Afinity CQ2015A Intraocular LensThe visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.                STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.                                          

Siemens Medical Solutions USA; Inc        Jul-17-2013         Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus – Siemens AXIOM Artis zee/zeego systems equipped with generator A100 PlusProduct Usage:Angiographic x-ray system During the course of product monitoring; Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value; thus; the generator may fail.                                          

Synthes USA HQ; Inc.     Jul-17-2013         Synthes – Multi Vector Distractor Pin Holding Clamp; limited bone stockThe holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening; including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.      Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp; limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp; however there                                               

Edwards Lifesciences; LLC            Jul-17-2013         Edwards Lifesciences Suction Wand – Edwards Lifesciences Suction Wand; models S099 and S0998BSuction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.         Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.                                        

Boston Scientific Corporation     Jul-17-2013         Alair Bronchial Thermoplasty Catheter – Alair Bronchial Thermoplasty Catheter; Bronchial Thermoplasty System; Material Number: M005ATS25010; Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC); Sunnyvale; CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.                Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters.  The expiration date indicated on the inner tray; 2012-04; is incorrect. The correct expiration date is 2014-04 as indicated on the outer box label.                                   

Hospira Inc.        Jul-18-2013         LifeShield Symbiq Set – LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET; CONVERTIBLE PIN; PIGGYBACK; 2 CLAVES PORTS AND OPTION LOK; NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira; Inc.; Lake Forest; IL 60045 USAThe Hospira Symbiq Infusion System is a general infusion system which provides IV infusion across the general spectrum of clinical care. The Symbiq pumps are standard sized pumps which are typically facility-based infusion pumps which may be used to deliver continuous and/or intermittent infusions to a variety of patient populations.          Hospira has received reports of customers experiencing air-in-line alarms related to administration sets that have a drip chamber with a ball valve. Preliminary investigation findings found that there is a potential for the ball valve to not seal the drip chamber as intended; leading to air in the line of the administration set.                                       

Leibel-Flarsheim Company LLC   Jul-18-2013         Hydra Vision DR 60/80 System – Hydra Vision DR 60/80 System; Models 700539 and 700540; Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.      A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min.                                               

Baxa Corporation             Jul-18-2013         ExactaMix 1200 and 2400 Compounders – ExactaMix 1200 and 2400 Compounders.Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.                Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight December 31; 2010.                                               

Ethicon Endo-Surgery Inc             Jul-19-2013         Endopath Electrosurgery Probe Plus II – Endopath Electrosurgery Probe Plus II; twelve (12) different devices; including hooks; spatulas; right angles; curved dissectors; suction/irrigation devices; accessory ports; pool/sump devices and stone retrieval cannula; packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton; with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection; coagulation; irrigation; and fluid evacuation through a common trocar sleeve. The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging  may affect the sterility of the device.                                

Physio Control; Inc.         Jul-19-2013         LIFEPAK 500 Automated External Defibrillator (AED) – The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient’s electrocardiographic (ECG) rhythmand indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments.    The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected; the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable.                                    

Ethicon Endo-Surgery Inc             Jul-19-2013         LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier – LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320); 10mm M/L; bulk non-sterileProduct Usage:The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360¿ in either direction. The rotating knob is located to allow for a one-handed technique.          Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP? 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation; vessel damage and/or insufficient occlusion of the vessel or other structure                                    

Ethicon Endo-Surgery Inc             Jul-19-2013         FlexTray " Procedure Delivery System Cholecystectomy Tray – LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays); 10mm M/L Product Usage:The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile; single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360¿ in either direction. The rotating knob is located to allow for a one-handed technique.    Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP? 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation; vessel damage and/or insufficient occlusion of the vessel or other structure                                               

Ethicon Endo-Surgery Inc             Jul-19-2013         LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier – LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320); 10mm M/L Product Usage:The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile; single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360¿ in either direction. The rotating knob is located to allow for a one-handed technique.            Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP? 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation; vessel damage and/or insufficient occlusion of the vessel or other structure                                

Topcon Medical Laser Systems; Inc          Jul-19-2013         PASCAL and PASCAL Streamline – PASCAL and PASCAL Streamline (532 nm.577 nm);Treats the patient’s eye.           When using the "Favorites" function for saved settings; there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.                                      

Del Mar Reynolds Medical; Ltd. Jul-19-2013         Spacelabs ARKON Anesthesia Workstation – Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen; air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator; and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.               Spacelabs ARKON Anesthesia System is recalled due to software defect.  The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs; a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error.                                          

Philips Healthcare Inc.    Jul-20-2013         Philips Healthcare IntelliVue Smart-hopping 1.4 GHz Access Point – Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05  Part Number: 989803171211Product Usage:IntelliVue Smart-hopping 1.4 GHz Access Point provides wireless connectivity between IntelliVue devices (listed below) and the Philips IntelliVue Information Center. MX40 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of; and to generate alarms for; multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network.       IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of severalminutes impacting wireless connectivity                                    

Myoscience Inc Jul-20-2013         iovera – Myoscience brand iovera Smart Tip; Myoscience Cryo-Touch IV; a Cryogenic Surgical device; REF Catalog Number: STA0311-10.Product Usage:The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV (a.k.a. iovera) is not indicated for treatment of central nervous system tissue.    The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements; specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." This product was previously labeled for EU distribution only.                                             

Siemens Medical Solutions USA; Inc        Jul-22-2013         ARTIS zee and zeego – ARTIS zee and zeego x-ray; angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed.Angiographic x-ray system                Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. The issue affects-DSA rotational acquisition. The restriction is related to any rotational 3D-acquisition program with real-time subtraction (e.g. 3D DSA). During the fill phase of the rotational aqui                                           

Pemco Inc           Jul-22-2013         Rultract Retractor Ratchet Cover Plate – Rultract Retractor Ratchet Cover Plate Distributed by Pemco; Inc.; Cleveland; OH 44131Surgical retractor used to lift the incision site             The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion.                                       

St. Jude Medical               Jul-22-2013         Eon and Eon Mini – Eon and Eon Mini charging system; model numbers Eon -3701 (Wall Charger); 3711 (Portable Charger) and Eon Mini -3721 (Charger);  This is a continuation of the firm’s July 2012 recall.Product Usage:The Eon Wall Charger (3701) provides the capability to recharge the IPG Battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The Eon Portable Charger (3711) provides the capability to recharge the IPG battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The patient can be mobile during the recharging process with a portable charger. The Eon Mini Charger (3721) provides the capability to recharge the IPG battery while stimulation is either on or off. The charger transmits RF energy through the antenna to the IPG battery to recharge it.            There is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs).  In the July 2012 letter St. Jude Medical informed customers that they would be implementing design improvements to the charger to address possible increased energy dissipation when the charger is misaligned with the IPG or the IPG is implanted too near the surface of the                                    

Steris Corporation           Jul-22-2013         STERIS Fine Traction Device – STERIS Fine Traction Device; one unit per boxProduct Usage:The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.           A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was  substituted per a change order.  The change order authorized use of the substitute bushing in assembly of the Fine Traction Accessory; however; inadvertently the new part was not implemented.  During complaint evaluati                                               

Instrumentation Laboratory Co.                Jul-22-2013         HemosIL RecombiPlasTin 2G; – HemosIL RecombiPlasTin 2G; Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.           Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G); Part No. 0020009580 (8 mL Size) due to being Out of Specification.                                        

Hill-Rom; Inc.     Jul-23-2013         TotalCare Bed (1900) – TotalCare Bed used with AccuMax Quantum VPC mattressAccuMax Quantum Complete mattress; and AccuMax Quantum Convertible mattressThe TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including; but not limited to; acute care; including critical care; step down/progressive care; medical/surgical; high acuity sub-acute care; post anesthesia care unit (PACU); and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. Hill-Rom is initiating this recall due to a  potential issue with TotalCare? Beds equipped with AccuMax Quantum"mattresses. If the bed is put into the chair egressposition; the magnets on the mattress may not holdthe bottom of the mattress flat to the bed frame. Ifthis happens; the foot section of the mattress willextend away from the bed at about a 30? angle (asshown in the photo).                                         

Philips Healthcare Inc.    Jul-24-2013         Philips HeartStart MRx  Monitor/Defibrillator; – Philips HeartStart MRx  Monitor/Defibrillator;Model numbers M3535A; M3536A; M3536J; M3536M; M3536MC; M3536M2; M3536M4; M3536M5; M3536M6The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support; advanced cardiac support; or defibrillation. It must be used by or on the order of a physician                The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect therapy; which may induce ventricular fibrillation.                                          

Siemens Medical Solutions USA; Inc        Jul-24-2013         Axiom Aristos MX – Axiom Aristos MX Solid State Flat Panel Digital Imager; Model number 5895003. The device is used for diagnostic X-ray imaging.              Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function "table top float" of the AXIOM Aristos MX. When repositioning a patient lying on the table top and releasing the table top; it is possible that the fingers of the patient or operator are between the table top and the detector tray and if  the table top is moved; the fingers can be squee                                  

Becton Dickinson & Co. Jul-24-2013         BD BBL Vancomycin Screen Agar – BD BBL Vancomycin Screen Agar; carton of 10 plates; catalog # 222204; labeled in part ***Becton; Dickinson and Company 7 Loveton Circle Sparks; MD 21152 USA 800-638-8663 www.bd.com/ds***Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.               Microbiological identification media may exhibit reduced levels of Vancomycin.                                               

Becton Dickinson & Co. Jul-24-2013         BD BBL Schaedler K-V Agar with 5% Sheep Blood – BD BBL Schaedler K-V Agar with 5% Sheep Blood; carton of 20 plates; catalog # 221555; labeled in part ***Becton; Dickinson and Company 7 Loveton Circle Sparks; MD 21152 USA 800-638-8663 www.bd.com/ds***Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.                Microbiological identification media may exhibit reduced levels of Vancomycin.                                

Becton Dickinson & Co. Jul-24-2013         BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV) – BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV); packaged in cartons of 100 plates; Catalog # 221736; and labeled in part ***Becton; Dickinson and Company  7 Loveton Circle Sparks; MD 21152 USA 800-638-8663 www.bd.com/ds***CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin is used for the selective isolation of fastidious and slow-growing; obligately anaerobic gram-negative bacteria from a variety of clinical and nonclinical materials.      Microbiological identification media may exhibit reduced levels of Vancomycin.                                

Becton Dickinson & Co. Jul-24-2013         BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar – BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar; packaged in cartons of 20 plates; Catalog # 297041; and labeled in part ***Becton; Dickinson and Company  7 Loveton Circle Sparks; MD 21152 USA 800-638-8663 www.bd.com/ds***Anaerobe Laked Sheep Blood KV Agar is used in a qualitative procedure for isolation of gram-negative anaerobic bacilli.           Microbiological identification media may exhibit reduced levels of Vancomycin.                                

Becton Dickinson & Co. Jul-24-2013         BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV – BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV; packaged in cartons of 100 plates; Catalog # 297260; and labeled in part ***Becton; Dickinson and Company  7 Loveton Circle Sparks; MD 21152 USA 800-638-8663 www.bd.com/ds***Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.        Microbiological identification media may exhibit reduced levels of Vancomycin.                                

Becton Dickinson & Co. Jul-24-2013         BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV) – BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV); Catalog # 297840; packaged in cartons of 20 plates; labeled in part ***Becton; Dickinson and Company  7 Loveton Circle Sparks; MD 21152 USA 800-638-8663 www.bd.com/ds***Brucella Laked Blood with KV is used for the selective isolation of fastidious and slow growing; obligately anaerobic bacteria from the same specimen.       Microbiological identification media may exhibit reduced levels of Vancomycin.                                

Becton Dickinson & Co. Jul-24-2013         BD BBL BCYE Selective Agar with PAV – BD BBL BCYE Selective Agar with PAV; Catalog # 297880; packaged in cartons of 10 plates; and labeled in part ***Becton; Dickinson and Company  7 Loveton Circle Sparks; MD 21152 USA 800-638-8663 www.bd.com/ds***BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula; except that the concentration of polymyxin B is reduced by half; and vancomycin is substituted for cefamandole.                Microbiological identification media may exhibit reduced levels of Vancomycin.                                

Becton Dickinson & Co. Jul-24-2013         BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium) – BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium); Catalog # 299614; packaged in cartons of 20 plates; and labeled in part ***Becton; Dickinson and Company  7 Loveton Circle Sparks; MD 21152 USA 800-638-8663 www.bd.com/ds***BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula; except that the concentration of polymyxin B is reduced by half; and vancomycin is substituted for cefamandole.             Microbiological identification media may exhibit reduced levels of Vancomycin.                                               

Haemonetics Corporation            Jul-24-2013         Thromboelastograph Instrument – TEG 5000 Thromboelastograph Coagulation AnalyzerProduct Usage:Multipurpose System for In Vitro Coagulation Studies           Research Use Only (RUO) parameters were included in TEG 5000 User Manual.                                     

Church & Dwight Inc       Jul-25-2013         Church and Dwight Inc. Sodium Bicarbonate; USP – Sodium Bicarbonate; USP Provided bulk as raw material – label not applicable according to firmDialysis Grade 1.5Dialysis Grade 2As an API or excipient in the manufacture of Medical Devices and Drugs             Church and Dwight Co.; Inc. has initiated a recall for Sodium Bicarbonate; USP produced by the Old Fort; OH Sodium Bicarbonate Production facility due to metal and other contamination.                                

Etac Supply Center Ab   Jul-25-2013         Swift Mobil Shower Chair – Swift Mobil shower chair; Swift Mobil 160 shower chair; and Swift Mobil Tilt shower chair.Height adjustable four wheeled shower chairs for persons of various weights.                Etac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair.  Among all Swift Mobils that have been distributed worldwide; Etac has between February 2012 andDecember 2012 received a total of 23 field reports where casters have come loose. None of the reports involved any harm or injury.                                         

Aesculap; Inc.    Jul-25-2013         Aesculap PEEK Intervertebral Body Fusion System – ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed; damaged; or unstable vertebral body due to tumor or trauma to achieve anterior decompression of the spinal cord and neural tissues; and to restore the height of a collapsed vertebral body.                Aesculap Implant Systems; LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant – 8 x 8.5 x 22 mm (SN038P) because the device is incorrectly etched with an 8 degree lordosis instead of a 5 degree lordosis. The device is labeled correctly; only the etching of the implant may be incorrect.                                        

Stryker Neurovascular   Jul-25-2013         Stryker brand Neuroform 3 Microdelivery Stent System – Stryker brand Neuroform 3 Microdelivery Stent System; 4.5 mm X 20 mm; REF Catalog Number: E345020; Model/Product Number: M003450200; Product is manufactured by Boston Scientific Corporation; Fremont; CA and distributed by Stryker Neurovascular; Fremont; CA The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck; intracranial; saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping.                The device is labeled incorrectly; in that; the device Model Number on the outer carton and inner pouch labels did not match; although both referenced the same lot number. The Model Number on the outer box states UPN M003E345020 (4.5mm x 20 mm Neuroform 3 Stent) while the pouch label states UPN M003E3450300 (4.5mm x 30 mm Neuroform 3 Stent).                                

Advanced Orthogonal Equipment; Incorporated               Jul-25-2013         Advanced Orthogonal Percussion Adjusting Instrument – Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra. Unapproved medical device                                      

Medtronic Neurosurgery             Jul-25-2013         Medtronic Preimplantation Test Kit; – Medtronic Preimplantation Test Kit; Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves; when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications.           Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had expiration dates that were incorrect.  The date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components in the kit.                                 

Becton Dickinson & Co. Jul-26-2013         BD Affirm VPIII Microbial Identification Tests – BD Affirm VPIII Microbial Identification Tests; packaged in kits; 120 test\kit; Catalog # 446257 and 24 test\kit; Catalog # 446252; kits are labeled in part ***Becton; Dickinson and Company; 7 Loveton Circle Sparks; MD 21152 USA; 800-638-8663; www.bd.com/ds***The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species;                In vitro diagnostic test kit may exhibit invalid internal negative control results.                                   

Leica Microsystems; Inc.               Jul-29-2013         Leica ASP6025 Advanced Smart Processor Vacuum Tissue Processor – Leica ASP6025 Vacuum Tissue ProcessorThe Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation; dehydration; infiltration with intermedium; and the paraffin infiltration of histological tissue specimens.              The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In case of a pressure failure of the device in combination with a bottle with incorrect dimensions; overflow can cause contamination of reagents. Additionally; the current instructions for use does not highlight the importance to check the fil                                 

Sotera Wireless; Inc.       Jul-29-2013         ViSi Mobile Chest Sensor (3 lead-wire ECG; AAMI); – ViSi Mobile Chest Sensor (3 lead-wire ECG; AAMI); Catalog No. 93-10014The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.          Sotera Wireless; Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.                                           

Custom Spine; Inc.          Jul-29-2013         Custom Spine ISSYS LP Inverted Screw System – Custom Spine ISSYS LP Inverted Screw System.  8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile.  Custom Spine; Inc. 9 Campus Dr. Parsippany; NJ  07054 USA.  TEL: 973-808-0019The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.          On March 28; 2013; Custom Spine; Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification.  The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm; but its length measured 40mm.                                              

Sotera Wireless; Inc.       Jul-29-2013         ViSi Mobile Monitor – ViSi Mobile Monitor; Catalog No. 92-10010The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.           Sotera Wireless; Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.                                              

Synthes USA HQ; Inc.     Jul-29-2013         Synapse SD Drill Guide – Synthes Synapse SD Drill Guide; Part Number SD389.477; Lot Number 6913900Indicated for Hooks; Plate/Rods; Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3); the plate/rod; rod; hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo        A complaint was received from the field; that the drill guide was etched incorrectly; 12mm etch instead of 18mm drill guide.  The firm identified that this constituted a field action and retrospectively reported this action.                                          

Picis Inc.               Jul-29-2013         ED PulseCheck – Picis ED Pulsecheck – EMR Software Application – 2125; Software Versions: 5.2 and 5.3.  The application stores patient information in a database; and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes. Notes associated with prescription are not printed to the prescription or to the patient chart.                                          

Synthes USA HQ; Inc.     Jul-29-2013         Synthes Large External Fixation; MR Conditional – Synthes Large External Fixation; MR Conditional; Tube to Tube Clamp; Part Number 390.007; Lot Number 6800599Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.                It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials.  Following a detailed investigation; it was determined that the incorrect insert was used which indicates that the device is MR Safe; when it is actually MR Conditional.                                        

Steritec Products Mfc. Co.; Inc.  Jul-29-2013         Getinge Assure Accufast BI Test Pack w/ 25 Controls – Getinge Assure Accufast BI Test Pack w/ 25 Controls; SteriTec Product Code PL 395/25; Distributor Product Code 61301606639The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.     Mesa Labs; based out of Bozeman; MT; informed SteriTec Products; Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.                                              

Steritec Products Mfc. Co.; Inc.  Jul-29-2013         Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack – Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack; SteriTec Product Code PL 298/25; Distributor Product Code SRSP/25The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and 3 minutes at 11357275re-vacuum steam sterilizers.   Mesa Labs; based out of Bozeman; MT; informed SteriTec Products; Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.                                               

Steritec Products Mfc. Co.; Inc.  Jul-29-2013         Medline Med-Checks BI Test packs with Instant Readout Integrator – Medline Med-Checks BI Test packs with Instant Readout Integrator; SteriTec Product Code PL 200; Distributor Product Code MDS200500IRSteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132¿C (270¿F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome        Mesa Labs; based out of Bozeman; MT; informed SteriTec Products; Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.                                      

HeartWare Inc   Jul-29-2013         Ventricular Assist Device – HeartWare Ventricular Assist SystemFor use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.                Potential to electrostatic discharged (ESD)                                          

Steritec Products Mfc. Co.; Inc.  Jul-29-2013         EZTest Steam Biological Indicator – EZTest Steam Biological Indicator; SteriTec Product Code EZS and EZS-400EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C; 132¿C; 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.    Mesa Labs; based out of Bozeman; MT; informed SteriTec Products; Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.                                              

Steritec Products Mfc. Co.; Inc.  Jul-29-2013         Cardinal Steam Biological Indicator – Cardinal Steam Biological Indicator; SteriTec Product Code PL 218; Distributor Product Code T40360EZEZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C; 132¿C; 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours. Mesa Labs; based out of Bozeman; MT; informed SteriTec Products; Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.                                       

Steritec Products Mfc. Co.; Inc.  Jul-29-2013         Medline Steam Biological Indicators – Medline Steam Biological Indicators; SteriTec Product Code PL 353; Distributor Product Code MDS200525EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C; 132¿C; 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours. Mesa Labs; based out of Bozeman; MT; informed SteriTec Products; Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.                                       

Steritec Products Mfc. Co.; Inc.  Jul-29-2013         Getinge Assure Accufast BI Test Pack w/ 5 Controls – Getinge Assure Accufast BI Test Pack w/ 5 Controls; SteriTec Product Code PL 395; Distributor Product Code 61301606638The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.   Mesa Labs; based out of Bozeman; MT; informed SteriTec Products; Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.                                               

Steritec Products Mfc. Co.; Inc.  Jul-29-2013         Cardinal BI Stat Biological Test Pack with Instant Readout Integrator – Cardinal BI Stat Biological Test Pack with Instant Readout Integrator; SteriTec Product Code PL 160/A; Distributor Product Code T40311PESteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132¿C (270¿F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome.         Mesa Labs; based out of Bozeman; MT; informed SteriTec Products; Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.                                          

Tosoh Smd Inc   Jul-30-2013         AIA Analyzer Pipette Tips – AIA Analyzer Pipette Tips used on Tosoh AIA-2000; AIA-1800; AIA-900 and AIA-600II Analyzers; 1000 tips/bagAIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.           Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.                                      

Wako Life Sciences; Inc.                Jul-30-2013         uTASWako DCP – uTASWako DCP; Lot TG340 2013.11; REF 995-60701; Wako Pure Chemical Industries; Ltd. 1-2 Doshomachi 3-chome; Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences; Inc. 1025 Terra Bella Ave.; Suto A. Mountain View; CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on asingle disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.          Product fails to meet the accuracy at the low end of the measuring range.