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Recall Archives 17 FDA RecallsJanuary 1, 2005 - June 30, 2005
\ The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 28, 2005: CLASS I MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Maple Grove, MN, by letter on December 2, 2005. Manufacturer Boston Scientific Cork Ltd., Cork, Ireland. Firm initiated recall is ongoing. PRODUCT: Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For Femoral Vein Introduction Only. Catalog No. 50-501. Sterile EO. Single Use Only. Read Instructions for Use before using this device. The Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm introducer System is a permanently implanted stainless steel device designed to protect against pulmonary embolism while maintaining potency of the inferior vena cava. The Stainless Steel Greenfield Vena Cava Filter comes preloaded in a 12 Fr. / 4,0 mm jugular or femoral introducer catheter. Recall # Z-0280-06 REASON: There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters with 12 Fr Femoral introducer Systems manufactured before March 10, 2004. If the capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization. CLASS II MANUFACTURER: Merit Medical Systems, Inc, South Jordan, UT, by fax and letter on October 21, 2005. Firm initiated recall is ongoing. PRODUCT: a) Viceroy Inflation Syringe, 60mL, Sterile, Rx only. Catalog Number: V6010, Recall # Z-0290-06; b) Viceroy Inflation Syringe, 60mL, without gauge. Catalog Number: V6001, Recall # Z-0291-06 REASON: Inflation device may not hold vacuum during angioplasty procedure. MANUFACTURER Abbott Spine, Austin, TX, by telephone beginning on November 11, 2005 and by letters on November 14, 2005. Firm initiated recall is ongoing. PRODUCT: a) SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine, SlimLine Hybrid, Corpectomy, ThinLine and Ant-Cer Anterior Cervical Plating Systems, Recall # Z-0292-06; b) SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine and SlimLine Hybrid Anterior Cervical Plating Systems, Recall # Z-0293-06; c) SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Corpectomy Anterior Cervical Plating Systems, Recall # Z-0294-06; d) SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix ThinLine Anterior Cervical Plating Systems, Recall # Z-0295-06; e) SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Ant-Cer Anterior Cervical Plating Systems, Recall # Z-0296-06 REASON: Modification to labeling for surgical implant. MANUFACTURER: ABX Diagnostics Inc, Irvine, CA, by letter on April 8, 2004. Firm initiated recall is ongoing. PRODUCT: Pentra 80 and Pentra 80XL Hematology Analyzers, Recall # Z-0298-06 REASON: Software defect, instrument may erroneously give a result of “0” or “---”. MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Maple Grove, MN, by letters dated August 4, 2005. Manufacturer: Boston Scientific Cork Ltd., Cork, Ireland. Firm initiated recall is ongoing. PRODUCT: a) Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm FlexCarrier Capsule. Catalog no. M001505010. Sterile EO. Single Use Only. The devices are permanently implanted devices designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. It is inserted through the internal jugular or femoral vein using a percutaneous puncture or surgical cutdown. The Stainless Steel Greeenfield Vena Cava Filter comes preloaded in a 12 Fr. / 4.0 mm jugular or femoral introducer catheter. Recall # Z-0299-06; b) Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no. M001503010. Sterile EO. Single Use Only. The devices are permanently implanted devices designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. It is inserted through the internal jugular or femoral vein using a percutaneous puncture or surgical cutdown. The Titanium Greeenfield Vena Cava Filter comes preloaded in a jugular or a femoral introducer catheter. Recall # Z-0300-06 REASON: Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing a tear. MANUFACTURER: Smiths Medical ASD, Inc., Gary, IN, by letter dated July 25, 2005. Firm initiated recall is complete. PRODUCT: Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70. Recall # Z-0301-06 REASON: Instructions for use included in the package are for a different tracheostomy tube. MANUFACTURER: Invacare Corporation, Elyria, OH, by telephone and letters on October 11, 2005. Firm initiated recall is ongoing. PRODUCT: 3G Storm Series Power Wheelchair with Power Tilt Option. Recall # Z-0303-06 REASON: When the powered seating system is tilted completely in the rearward position, a potential pinch point is created between the seat and the seat frame. MANUFACTURER: Recalling Firm: Dade Behring, Inc., Newark, DE, by letter dated September 30, 2005. Manufacturer: Dade Behring GmbH, Marburg, Germany. Firm initiated recall is ongoing. PRODUCT: Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100, Recall # Z-0304-06 REASON: Prolonged aPTT results. MANUFACTURER: Witt Biomedical Corporation, Melbourne, FL, by telephone on September 16, 2005. Firm initiated recall is complete. PRODUCT: Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053, Recall # Z-0305-06 REASON: Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident. CLASS III MANUFACTURER: Thomas Medical Products Inc, Malvern, PA, by letters on November 7 and November 14, 2005. Firm initiated recall is ongoing. PRODUCT: Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouches and shipped 5 pouches per case. Catalog number 808950, Recall # Z-0297-06 REASON: Mislabeled as 9.5F actually contains 10.5F. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 21, 2005: CLASS I MANUFACTURER: Recalling Firm: Baxter Healthcare Corporation, Renal Division, McGaw Park, IL, by letters dated September 28, 2005. Manufacturer: Baxter Healthcare Corporation, Largo. FL. Firm initiated recall is ongoing. PRODUCT: Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Recall # Z-0275-06 REASON: Inadequate instructions for routing single tubing lines through the double-tubing clips on the front of the instrument to eliminate the risk of kinks in the tubing, which have been associated with a death and a serious injury. CLASS II MANUFACTURER: Recalling Firm: Guidant Corporation, Saint Paul, MN, by
press release and letters dated September 22, 2005, and by Advisory update
in December 2005. PRODUCT: a) Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of pacemakers includes the following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Entra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single- chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive- rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide. Recall # Z-0191-06; b) Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. Two sensors are available: these adapt the pacing rate to the patient’s changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide. Recall # Z-0192-06; c) Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (model 1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 1394) and DR (model 1467, 1468). The INSIGNIA I Plus pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Plus pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available: these adapt the pacing rate to the patient's changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Plus models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide. Recall # Z-0193-06; d) Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers includes the following: SR (model 1392). The INSIGNIA I AVT pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I AVT pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. The INSIGNIA and NEXUS I Plus adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide. Recall # Z-0194-05 REASON: Another failure mode, which occurs at a low rate, has been identified with the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include; intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation. MANUFACTURER: Recalling Firm: Liko, Inc, Franklin, MA, by letter on/about December 1, 2005. Manufacturer: Liko AB, Lulea, Sweden. Firm initiated recall is ongoing. PRODUCT: a) Liko UNO 100 Patient Lift, Recall # Z-0276-06; b) Liko UNO 102 Patient Lift, Recall # Z-0277-06; c) SABINA I and SABINA II Patient Lift, Recall # Z-0278-06 REASON: Incorrect length leg pin bolts may cause patient lift failures. MANUFACTURER: Styker Endoscopy, San Jose, CA, by letters on November 18, 2005. Firm initiated recall is ongoing. PRODUCT: StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620, Recall # Z-0279-06 REASON: Devices sterility may be compromised as evidenced by a crack in the package. MANUFACTURER: Becton Dickinson Infusion Therapy, Sandy, UT, by telephone and letter on March 25, 2005. PRODUCT: a) 16 G /5F Dual Lumen L-Cath catheter only. Recall # Z-0282-06; b) 16 G / 5F Dual Lumen L-Cath Basic Kit with Insyte Autoguard, Recall # Z-0283-06; c) 16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte Autoguard, Recall # Z-0284-06; d) 16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte, Recall # Z-0285-06; e) 16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte, Recall # Z-0286-06; f) 16 G / 5F Dual Lumen L-Cath Basic Kit with U-Wing, Recall # Z-0287-06; g) 16 G / 5F Dual Lumen L-Cath complete kit with U-Wing, Recall # Z-0288-06 REASON: Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters. CLASS III MANUFACTURER: Recalling Firm: Toshiba American Med Sys Inc, Tustin, CA, by letter on letter on October 12, 2005. Manufacturer: Toshiba Medical Systems Company, Tochigi-Ken, Japan. Firm initiated recall is ongoing. PRODUCT: Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR § 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490, Recall # Z-0281-06 REASON: There is a hardware problem of water leakage in the cooling system inside the ASGC, requiring the replacement of the gradient coil. MANUFACTURER: Recalling Firm: Bio-Rad Laboratories, Inc, Hercules, CA, by telephone, fax and e-mail on June 4, 2004. Manufacturer: Applied Biotech Inc., San Diego, CA. Firm initiated recall is complete. PRODUCT: Bio-Rad brand "TOX/See Drug Screen Test"; Catalog numbers: 1945182EX, 1945216, 194-5223, Recall # Z-0289-06 REASON: The device was producing false negative results for cocaine tests. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 14, 2005: CLASS II MANUFACTURER: Pascal Company, Inc., Bellevue, WA, by telephone on August 10, 2005 and October 3, 2005 and by letters on August 12, 2005 and October 6, 2005. Firm initiated recall is ongoing. PRODUCT: Product labeled in part: "**Banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%***NET CONTENTS: 3.8l (ONE U.S. GALLON)*** Recall # Z-1588-05 REASON: The product, Banicide Advanced, a reusable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use. MANUFACTURER: Cobe Cardiovascular, Inc, Arvada, CO, by letter on October 6, 2005. Firm initiated recall is ongoing. PRODUCT: Custom heart lung perfusion packs, Recall # Z-0265-06 REASON: One way valve in the heart lung pack assembly may be missing. MANUFACTURER: Recalling Firm: ela Medical Llc, Plymouth, MN, by letter dated October 25, 2005. Manufacturer: ELA Medical, S.A.S., Montrouge, France. Firm initiated recall is ongoing. PRODUCT: a) Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge -- France. Made in France. Recall # Z-0266-06; b) ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France. Recall # Z-0267-06 REASON: Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process. MANUFACTURER: C.R. Bard, Urological Division, Covington, GA, by letter on November 7/8, 2005. Firm initiated recall is ongoing. PRODUCT: Bard UroForce™ Balloon Dilation Catheter with Glissando™ Coating * BARD * Sterile/EO, Recall # Z-0268-06 REASON: There is a potential for the lumen to collapse and prevent passage over a guidewire. MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letters on September 20, 2005. Firm initiated recall is ongoing. PRODUCT: Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, List Numbers: 99226-01, 08H17-01,(on box), 99226-01, 08H17-02 (on bottle); Recall # Z-0269-06 REASON: The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (Hgb) test results. MANUFACTURER: Lifescan Inc, Milpitas, CA, by letters on October 11, 2005. Firm initiated recall is ongoing. PRODUCT: LifeScan OneTouch SureSoft Lancing Device, single use lancing device. Recall # Z-0271-06 REASON: In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks. MANUFACTURER: Recalling Firm: Eastman Kodak Co, Rochester, NY, by letters dated October 20, 2005. Manufacturer: Analogic Corporation, Peabody, MA. Firm initiated recall is complete. PRODUCT: KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit. Recall # Z-0274-06 REASON: Potential weld defect in the Overhead Tube Support assembly which connects the tube assembly to the telescoping arm. This could cause the tube assembly to fall, injuring anyone near the unit. CLASS III MANUFACTURER: Wilson-Cook Medical Inc, Winston Salem, NC, by letter on/about November 4, 2005. Firm initiated recall is ongoing. PRODUCT: Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable - Single Use Only * Compatible Wire Guide: .035” * Rx Only, Recall # Z-0270-06 REASON: Misbranded; The catheter size listed on the product label is 6 French, which is inaccurate. The catheter size is 7 French. MANUFACTURER: Lifescan Inc, Milpitas, CA, by letter dated October 10, 2005. Firm initiated recall is ongoing. PRODUCT: LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter, Recall # Z-0272-06 REASON: Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters. MANUFACTURER: Lifescan Inc, Milpitas, CA, by letter on October 19, 2005. Firm initiated recall is ongoing. PRODUCT: LifeScan brand OneTouch Ultra Test strips, 25 strips per vial, part number 020-245-07, Recall # Z-0273-06 REASON: Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 7, 2005: CLASS II ****DEVICE RECALL EXTENDED**** MANUFACTURER: Recalling Firm: Teleflex Medical, Bannockburn, IL, by letters dated July 11, 2005. Manufacturer: Teleflex Medical, Nueva Laredo, Mexico. Firm initiated recall is ongoing. PRODUCT: Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per box; product number RLA-142-3, Recall # Z-1083-05. Originally reported in August 17, 2005 Enforcement Report. REASON: There is a lack of assurance of sterility for parts of these lots of product. MANUFACTURER: Abbott Laboratories, Columbus, OH, by telephone and letter dated October 7, 2005. Firm initiated recall is ongoing. PRODUCT: Fleixiflo Quantum Enteral Pump, Recall # Z-0145-06 REASON: Pumps have the potential to malfunction and result in a significant over-under delivery of enteral formula. MANUFACTURER: Advanced Sterilization Products, Irvine, CA, by letter on September 22, 2005. Firm initiated recall is ongoing. PRODUCT: Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S, Recall # Z-0197-06 REASON: The STERRAD 100 and the STERRAD 100S vaporizer plates are prone to displacement allowing micro-droplets of H2O2 to contact the load. If the vaporizer plate is dislodged, there is an increased chance for operators to have contact with H2O2 resulting in transient burns during the removal of the load. MANUFACTURER: Recalling Firm: Toshiba American Med Systems, Inc., Tustin, CA, by letter on September 21, 2005. Firm initiated recall is ongoing. PRODUCT: High voltage generator XTP-8100G and XTPG-8100G for the Infinx-I series interventional angiography system. Recall # Z-0198-06 REASON: Arcing might occur in the transformer of the high voltage generator, XTP-8100G and XTBP-8100G displaying an error message and interrupting fluoroscopy. MANUFACTURER: Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL, by letters dated March 17, 2005. Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR. Firm initiated recall is ongoing. PRODUCT: Baxter and Baxter Interlink Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150 mL Burette Ball Valve, 2 injection sites and male luer lock adapter; Recall # Z-0199-06 REASON: The Buretrol solution sets are currently labeled as acceptable for use with the Colleague Volumertric Pump, but there is a potential for a non-detection of an upstream occlusion under certain conditions. MANUFACTURER: Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letter dated September 12, 2005 and by email or fax between September 12, 2005 and September 14, 2005. Firm initiated recall is ongoing. PRODUCT: Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only, Recall # Z-0200-06 REASON: There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts. MANUFACTURER: Ferno-Washington Inc., Wilmington, OH, by letter dated March 28, 2003 and June 24, 2003. Firm initiated recall is ongoing. PRODUCT: a) PROFlex Transporter, Model numbers 35PST. Catalog number is PT3565, Recall # Z-0201-06; b) PROFlex Transporter, Model numbes 35P. Catalog number is PT3550, Recall # Z-0202-06 REASON: The firm received complaints of the stretchers folding. A fold is when the stretchers lowers on its own to either the next position, or any of the other seven positions of the stretcher. MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co, Phillips, Bothell, WA, by letter on October 10, 2005. Manufacturer: Philips Medical Systems, Netherlands. Firm initiated recall is ongoing. PRODUCT: a) AD5 table for use with Integris and Integris Allura x-ray systems, Recall # Z-0206-06; b) AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version. Recall # Z-0207-06; c) AD5 table, modified, used with the XPER x-ray systems. The modification on the table is the cables used for connecting to the XPER systems. Recall # Z-0208-06; d) AD6 table, modified, used with the XPER systems. The modification on the table is the cables used for connecting to the XPER systems. Recall # Z-0209-06 REASON: Potential for high voltage exposure involving the injector interface connector of patient support tables. MANUFACTURER: Cryolife Inc, Kennesaw, GA, by letter starting November 17, 2003. Firm initiated recall is ongoing. PRODUCT: a) CryoValve, Alt Aortic Valve & Conduit, Donor #30436, Model #AV05, Donor #30676, Model #AV05, Recall # Z-0210-06; b) CryoValve, Alt Pulmonary Valve, Donor #29892, Model #PV15, Recall # Z-0211-06; c) CryoValve, Alt Pulmonary Valve & Conduit, Donor #28776, Model #PV05, Donor #29275, Model #PV05, Donor #30815, Model #PV05, Recall # Z-0212-06; d) CryoValve, Aortic Valve, Donor #28956, Model #AV10, Recall # Z-0213-06; e) CryoValve, Aortic Valve & Conduit, Donor #29051, Model #AV00, Donor #67609, Model #AV00, Donor #68422, Model #AV00, Donor #69368, Model #AV00, Donor #69826, Model #AV00, Donor #69934, Model #AV00, Donor #30373, Model #AV00, Recall # Z-0214-06; f) CryoValve, Aortic Valve & Conduit SG, Donor #66126, Model #SGAV00, Donor #66858, Model #SGAV00, Donor #67001, Model #SGAV00, Donor #67404, Model #SGAV00, Recall # Z-0215-06; g) CryoValve, Pulmonary Valve, Donor #29558, Model #PV10, Recall # Z-0216-06; h) CryoValve, Pulmonary Valve & Conduit, Donor #68206, Model #PV00, Donor #68241, Model #PV00, Donor #68422, Model #PV00, Donor #69368, Model #PV00, Donor #69826, Model #PV00, Donor #69934, Model #PV00, Donor #67086, Model #PV00, Donor #30309, Model #PV00, Recall # Z-0217-06; i) CryoValve, Pulmonary Valve & Conduit SG, Donor #65569, Model #SGPV00, Donor #66126, Model #SGPV00, Donor #67001, Model #SGPV00, Donor #67404, Model #SGPV00, Donor #61482, Model #SGPV00, Donor #66320, Model #SGPV00, Donor #66035, Model #SGPV00, Recall # Z-0218-06 REASON: Previously released tissues no longer meet CryoLife’s enhanced suitability release criteria because donors possessed a positive post processing microbiological culture of “potentially pathogenic” organisms. MANUFACTURER: LaMaitre Vascular, Inc., St Petersburg, FL, by letter on May 17, 2005. Firm initiated recall is ongoing. PRODUCT: Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: "***LeMaitre VASCULAR** FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***", Recall # Z-0219-06 REASON: LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility. MANUFACTURER: Smiths Medical PM, Inc., Waukesha, WI, by email or telephone beginning September 1, 2005. Firm initiated recall is ongoing. PRODUCT: a) Advisor Vital Signs Monitor (model 9200), catalog number 920634235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1)with 3-lead 60 Hz ECG, standard SPO2 option, printer and battery, Recall # Z-0220-06; b) Advisor Vital Signs Monitor (model 9200), catalog number 920654230, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) with 3-lead 60 Hz ECG, standard SPO2 option, and printer; Recall # Z-0221-06; c) Advisor Vital Signs Monitor (model 9200), Catalog number 920654235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) with 3-lead 60 Hz ECG, standard SPO2 option, printer and battery, Recall # Z-0222-06; d) Advisor Vital Signs Monitor (model 9200), catalog number 920654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1)3-lead 60 Hz ECG, standarn SPO2, Invasive pressure/ temperature option, printer and battery, Recall # Z-0223-06; e) Advisor Vital Signs Monitor (model 9200), catalog number 920655235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) 3-lead 60 Hz ECG, Nellcor SPO2 option, printer and battery, Recall # Z-0224-06; f) Advisor Vital Signs Monitor (model 9200), catalog number 920754235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) 5-lead 60 Hz ECG, standard SPO2 option, printer and battery, Recall # Z-0225-06; g) Advisor Vital Signs Monitor (model 9200), catalog number 925454220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 50 Hz ECG and standard SPO2 option, Recall # Z-0226-06; h) Advisor Vital Signs Monitor (model 9200), catalog number 925454225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 50 Hz ECG, Standard SPO2 option and battery, Recall # Z-0227-06; i) Advisor Vital Signs Monitor (model 9200), catalog number 925454325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MMD marking, 3-lead 50 Hz ECG, standard SPO2 option, Invasive Pressure/Temp option and battery, Recall # Z-0228-06; j) Advisor Vital Signs Monitor (model 9200), catalog number 925454335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) EC/MDD marking, 3-lead 50Hz ECG, standard SPO2 option, Invasive Pressure/Temperature option, printer and battery, Recall # Z-0229-06; k) Advisor Vital Signs Monitor (model 9200), catalog number 925474335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 50 Hz ECG, standard SPO2 option, Invasive Pressure/Temperature option, printer and battery, Recall # Z-0230-06; l) Advisor Vital Signs Monitor (model 9200), catalog number 925534325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 5-lead 50 Hz ECG, standard SPO2 option, Invasive Pressure/Temperature and battery, Recall # Z-0231-06; m) Advisor Vital Signs Monitor (model 9200), catalog number 925654320, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 60 Hz ECG, standard SPO2 option and Invasive Pressure/Temperature option, Recall # Z-0232-06; n) Advisor Vital Signs Monitor (model 9200), catalog number 925654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 60 Hz ECG, standard SPO2 option, Invasive Pressure/Temperature option, printer and battery, Recall # Z-0233-06; o) Advisor Vital Signs Monitor (model 9200), catalog number 925674325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 60 Hz ECG, standard SPO3 option, Invasive Pressure/Temperature and battery, Recall # Z-0234-06; p) Advisor Vital Signs Monitor (model 9200), catalog number 925754220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 5-lead 60 Hz ECG and standard SPO2 option, Recall # Z-0235-06; q) Advisor Vital Signs Monitor (model 9200), catalog number 925754225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 5-lead 60 Hz ECG, standard SPO2 and battery, Recall # Z-0236-06; r) Advisor Vital Signs Monitor (model 9200), catalog number 925754325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 5-lead 60 Hz ECG, standard SPO2 option, Invasive Pressure/Temperture option, printer and battery, Recall # Z-0237-06; s) Advisor Vital Signs Monitor (model 9200), catalog number 92D654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) 3-lead 60 Hz ECG, standard SPO2 option, Invasive Pressure/Temperature, printer and battery, Recall # Z-0238-06; t) Advisor Vital Signs Monitor (model 9200), catalog number 92D754335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) 5-lead 60 Hz ECG, standard SPO2 option, invasive Pressure/Temperature, printer and battery, Recall # Z-0239-06; u) Advisor Vital Signs Monitor (model 9200), catalog number 92E654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) 3-lead 60 Hz ECG, standard SPO2 option, invasive Pressure/Temperature option, printer and battery, Recall # Z-0240-06 REASON: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor. MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on November 22, 2004. Manufacturer: Stryker Trauma, Kiel, Germany. Firm initiated recall is complete. PRODUCT: Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right, Catalog 3220-0320S and 125 degree catalog number 3225-0360S, Recall # Z-0241-06. REASON: The Gamma Nail manufactured with an incorrect lag screw hole angulation. Catalog number 3220-0320S, Lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. Catalog number 3225-0360S, Lot code K949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees. MANUFACTURER: Smiths Medical ASD, Inc., Keene, NH, by letter on November 17, 2005. Firm initiated recall is ongoing. PRODUCT: a) Portex 4902 Glass L.O.R. Syringe, Recall # Z-0242-06; b) Portex 4903 Glass L.O.R. Syringe, Recall # Z-0243-06; c) Portex 4904 Glass L.O.R. Syringe, Recall # Z-0244-06; d) 4950-16 Portex Epidural Mini-pack, Recall # Z-0245-06; e) 4950-17 Portex Epidural Mini-pack, Recall # Z-0246-06; f) 4950-18 Portex Epidural Mini-pack, Recall # Z-0247-06; g) 4954-16 Portex Epidural Mini-pack, Recall # Z-0248-06; h) 4954-17 Portex Epidural Mini-pack, Recall # Z-0249-06; i) A1272-17 Portex Epidural Mini-pack, Recall # Z-0250-06; j) A1378-18 Portex Epidural Mini-pack, Recall # Z-0251-06; k) A1967-18 Portex Epidural Mini-pack, Recall # Z-0252-06; l) A1991-18 Portex Epidural Mini-pack, Recall # Z-0253-06; m) A2549-22 Spinal Needle, Recall # Z-0254-06; n) A3176-18 Portex Epidural Mini-pack, Recall # Z-0255-06; REASON: Tray may contain holes compromising the sterility of the device. MANUFACTURER: Recalling Firm: Styker Howmedica Osteonics Corp, Mahwah, NJ, by letters on September 7, 2004. Manufacturer: Stryker Trauma, Kiel, Germany. Firm initiated recall is complete. PRODUCT: Long Length Dyax Nail, Catalog No. 1594-4430S, Recall # Z-0256-06 REASON: Device was manufactured with a lag screw hole angulation of 135 degrees rather than 130 degrees. MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on October 25, 2005 Manufacturer: Applied Medical Technology, Inc., Cleveland, OH. Firm initiated recall is ongoing. PRODUCT: a) TLC Self -Retaining Retractor System-Single Product Code: 820-175, Recall # Z-0257-06; b) TLC Self -Retaining Retractor System-5/box Product Number:820-176, Recall # Z-0258-06; c) TLC Retractor and Single Step Pelvic Drape (contains 1 Product Code 820-175) Product Code: 820-177, Recall # Z-0259-06; d) Precision Twist Transvaginal Sling Kit with Non-Absorbable, Polybutester Monofilament Suture (contains 1 Product Code 820-175) Product Code: 820-172, Recall # Z-0260-06; e) Precision Tack Transvaginal Sling Kit with Non-Absorbable, Braided Polyester Suture (contains 1 Product Code 820-175) Product Code: 820-171, Recall # Z-0261-06; f) Capio CL Kit Transvaginal Suture Capturing Device (1TLC Retractor box) Product Code: 831-130, Recall # Z-0262-06; g) Precision Tack Transvaginal Sling Kit with Non-Absorbable, Polybustester Monofilament Suture (contains 1 Product Code 820-175) Product Code: 820-124, Recall # Z-0263-06; h) Precision Tack Transvaginal Sling Kit with Non-Absorbable, Braided Polyester Suture (contains 1 Product Code 820-175) Product Code: 820-123, Recall # Z-0264-06 REASON: Sterility of device compromised due to breach in packaging. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 30, 2005: CLASS II PRODUCT: cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E and Disposables: cardioPAT Replacement RBC Bags, LN 00270 cardioPAT Replacement Waste Bags, LN 00271 cardioPAT Replacement Intraoperative Suction Set, LN 00272 cardioPAT Replacement Postoperative Suction Set, LN 00273 cardioPAT cardiovascular Perioperative Autotransfusion System Disposable Set, LN 00274 cardioPAT Replacement One-Way Valve Assembly LN 00275, Recall # Z-0174-06 MANUFACTURER: Haemonetics Corporation, Braintree, MA, by letter on July 22, 2005. Firm initiated recall is ongoing. REASON: Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System. PRODUCT: Lysus® Infusion System - PT-3 Control. The Lysus Infusion System employs high frequency, low power ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) The Lysus® Infusion System consists of three main components, a single use Lysus® Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus® Infusion Catheter System, Recall # Z-0175-06 MANUFACTURER: Ekos Corporation, Bothell, WA, by visit beginning on January 19, 2005. Firm initiated recall is complete. REASON: Potential for a faulty thermal channel offset to be reported to the software causing faulty lower temperature values to be reported which allow a power increase. PRODUCT: Bard RespiShield™ * Closed Suction System with InnoValve™ * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only, Recall # Z-0178-06 MANUFACTURER: Recalling Firm: C.R. Bard, Inc., Covington, GA, by letter on/about September 28, 2005. Manufacturer: Bard Sdn Bhd, Nogales, Mexico. Firm initiated recall is ongoing. REASON: Varying degrees of difficulty were encountered when opening and closing the InnoValve. PRODUCT: a) FHC microTargeting Power Assist System used with the micro
Targeting Drive System, models: 66-DA-ME; 66EL-MC; 66EL-MS; 66EL-MS-02;
66-EL-MS-03; 66-EL-RM; MT-DS-AM; MT-DS-MD. Recall # Z-0179-06; b)
Medtronic microTargeting Drive Motor Option used with the micro Targeting
Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and
FHC 1008-66, MANUFACTURER: FHC, Inc, Bowdoinham, ME, by letter on October 31, 2005. Firm initiated recall is ongoing. REASON: Power Assist microTargeting System may advance beyond intended target PRODUCT: Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD with 3/8 inch connector, 14 inches (35 cm) long; catalog number 7080. Recall # Z-0181-06 MANUFACTURER: Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by telephone, and letter dated October 19, 2005. Firm initiated recall is ongoing. REASON: The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package. PRODUCT: AQuify™ Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Sterile, Recall # Z-0182-06 MANUFACTURER: Recalling Firm: CIBA Vision Corporation, Duluth, GA, by telephone and letter on November 4, 2005. Manufacturer: Ciba Vision Sterile Manufacturing, Ontario, Canada. Firm initiated recall is ongoing. REASON: Lack of assurance of sterility at the time of manufacture. PRODUCT: Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System). Recall # Z-0183-06 MANUFACTURER: Recalling Firm: Theken Spine LLC, Akron, OH, by letter, dated April 4, 2005. Manufacturer: Holmed Corporation, South Easton, MA. Firm initiated recall is ongoing. REASON: The torque value of the device may increase over time. The increase could exceed the tolerance specification. PRODUCT: a) Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-1000 is a prescription medical device suitable for use in institutional, home and transport settings. Recall # Z-0184-06; b) Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-950. The LTV-950 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-950 is a prescription medical device suitable for use in institutional, home and transport settings. Recall # Z-0185-06; c) Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-900. The LTV-900 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-900 is a prescription medical device suitable for use in institutional, home and transport settings. Recall # Z-0186-06 MANUFACTURER: Pulmonetic Systems, Inc., Minneapolis, MN, by letter dated November 9, 2005. Firm initiated recall is ongoing. REASON: Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm. PRODUCT: a) Guidant INSIGNIA I Entra family of pacemakers includes the
following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR
(models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS
Entra family of pacemakers includes the following: SSI (model 1326); DDD
(model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra
pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I
Entra pacemakers are multiprogrammable pacemakers from Intermedics. The
family consists of both dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various levels of therapeutic and
diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate
models have an accelerometer, which is a motion sensor that responds to
patient activity. Sterilized with gaseous ethylene oxide. Recall #
Z-0187-06; b) Guidant INSIGNIA I Ultra family of pacemakers includes the
following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I
Ultra family of pacemakers includes the following: SR (model 1390) and DR
(model 1490, 1491). The INSIGNIA I Ultra pacemakers are multiprogrammable
pacemakers from Guidant. The NEXUS I Ultra pacemakers are
multiprogrammable pacemakers from Intermedics. The family consists of both
dual-chamber and single-chamber models, offering adaptive-rate therapy and
providing various levels of therapeutic and diagnostic functionality.
These pacemakers include ventricular Automatic Capture which automatically
measures the ventricular pacing threshold and adjusts the pacing output to
0.5 V above the measured threshold. Two sensors are available: these adapt
the pacing rate to the patient’s changing metabolic demand. Minute
ventilation responds to changes in respiration, and the accelerometer
responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models
can use either the accelerometer or minute ventilation sensor, or a blend
of both accelerometer and minute ventilation. Sterilized with gaseous
ethylene oxide, Recall # Z-0188-06; c) Guidant INSIGNIA I Plus family of
pacemakers includes MANUFACTURER: Recalling Firm: Guidant Corporation, St. Paul, MN, by press release and letter dated September 22, 2005. Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing. REASON: A failure mode occurring at a low rate, has been identified within the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include: Intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation. PRODUCT: a) Guidant INSIGNIA I Entra family of pacemakers includes the
following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR
(models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS
Entra family of pacemakers includes the following: SSI (model 1326); DDD
(model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra
pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I
Entra pacemakers are multiprogrammable pacemakers from Intermedics. The
family consists of both dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various levels of therapeutic and
diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate
models have an accelerometer, which is a motion sensor that responds to
patient MANUFACTURER: Recalling Firm: Guidant Corporation, St. Paul, MN, by press release and letter dated September 22, 2005. Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing. REASON: Another failure mode, which occurs at a low rate, has been identified with the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include; intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation. PRODUCT: LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary Port; a sterile Rx blood administration set for use with the Plum Series Infuser; list number 11235-03, Recall # Z-0195-06 MANUFACTURER: Recalling Firm: Hospira, Inc., Lake Forest, IL, by letters dated May 6, 2005. Manufacturer: Abbott Laboratories de Costa Rica S.A., La Aurora de Heredia, Costa Rica. Firm initiated recall is complete. REASON: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow. PRODUCT: Analogic SyneRad Multi Digital Radiology System, Model AN6150, Recall # Z-0196-06 MANUFACTURER: Analogic Corporation, Peabody, MA, by e-mail on October 14, 2005 and by letter on October 17, 2005. Firm initiated recall is complete. REASON: Potential weld defect in the Overhead Tube Support assembly which connects to the telescoping arm. This could cause the tube assembly to fall, leading to possible injury of the user or patient. PRODUCT: a) Damon 3 Bracket Upper Right lateral .022 slot This device is a fixed attachment on a tooth which Holds an archwire during orthodontic treatment. Part Number 491-4210, Recall # Z-0203-06; b) Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211, Recall # Z-0204-06 MANUFACTURER: Ormco Corporation, Glendora, CA, by telephone and letters on November 3, 2005. Firm initiated recall is ongoing. REASON: Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance. PRODUCT: Self Contained Biological Indicator, product code SCRE-06, Recall # Z-0205-06 MANUFACTURER: Recalling Firm: Namsa, Northwood, OH, by telephone on or about March 18, 2005 and by letter on or about March 31, 2005. Manufacturer: Raven Biological Labs, Inc., Ralston, NB. Firm initiated recall is ongoing. REASON: The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification. CLASS III PRODUCT: a) Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alarms. Monitor can monitor, display, trend and print a patient’s physiological parameters. The device has a 12.1 inch color display and has a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, non-invasive blood pressure, respiration, continuous temperature and IV Drug Calculations. Optional digital displays are provided for invasive blood pressure (up to four) anesthetic agents, O2 and NO2, ST, and CO2,Recall # Z-0176-06; b) Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate derived from selected sources (Sp)2, ECG, IBP and NIBP), SpO2 level, ST Segment, Arrhythmia, Blood pressure (both invasive and non-invasive), Respiration rate (dirived from ECG or CO2), inspired or expired CO2, temperature, and gases(i.e. five anesthetsia gases, O2, N2O, and CO2), Recall # Z-0177-06 MANUFACTURER: Datascope Corp, Mahwah, NJ, by letter on September 7, 2005. Firm initiated recall is ongoing. REASON: Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 23, 2005: CLASS II PRODUCT: Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Recall # Z-0130-06 MANUFACTURER:Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL, by letters dated February 10, 2005. Manufacturer: Baxter Healthcare Corporation, Singapore. Firm initiated recall is ongoing. REASON: Potential failures of the pump due to upstream occlusion alarms, electro-static discharge, system error 32 or 33, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump. PRODUCT: Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom Cardiovascular Procedure Kits (Convenience Kits). Recall # Z-0140-06 MANUFACTURER: Recalling Firm: Terumo Cardiovascular Systems Corp., Ann
Arbor, MI, by telephone on July 26, 2005 and by letter dated July 28,
2005. REASON: Small cracks in the blood chamber may allow air to enter the rotor of the device. PRODUCT: a) D-Stat Dry Hemostatic Bandage, model number 3000. Sterile, latex free single use device. Vascular. Each D-Stat Dry hemostatic bandage (D-Stat Dry) consists of the following components: -Lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride in a nonwoven gauze; -Adhesive bandage, Recall # Z-0142-06; b) D-Stat Hemostat Band, model number 3500. Sterile, latex free single use device. Each D-Stat Radial hemostatic band (D-Stat Radial) consists of the following components: -Lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride in a nonwoven gauze; -Application device consisting of an adjustable retention strap, collar and attached gauze pad, Recall # Z-0143-06; c) D-Stat 2 Dry Hemostatic Bandage, model number 3010. Sterile, latex free single use device. Each D-Stat 2 Dry hemostatic bandage (D-Stat 2 Dry) consists of the following components: -One (1) scored lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride; -Two (2) Adhesive bandages. Recall # Z-0144-06 MANUFACTURER: Vascular Solutions, Inc., Osseo, MN, by letter dated September 9, 2005 and by Sales Representative visit beginning September 19, 2005. Firm initiated recall is ongoing. REASON: A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question. PRODUCT: a) Implantable Cardioverter Defibrillators: Photo DR, Model V-230HV, Recall # Z-0146-06; b) Photo Micro VR/DR, Models V-194, Recall # Z-0147-06;c) Photo Micro VR/DR, Models V-232, Recall # Z-0148-06; d) Atlas VR, Models V-199, Recall # Z-0149-06; e) Atlas DR, Model V-240, Recall # Z-0150-06 MANUFACTURER: St. Jude Medical, Sylmar, CA, by letter and press release on October 7, 2005. Firm initiated recall is ongoing. REASON: Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent loss of defibrillation support. PRODUCT: The Applied GelPort Hand Access Device, Model C8004, consists of a GelSeal Cap, Wound retractor (base). Standard Wound Protecting Sheath, Long Wound Protecting Sheath. Impervious Sleeve, Skin Marker. Sterile Lubricant, and Incision Template, UPC Codes: C8004 +H699C80040K. Recall # Z-0151-06 MANUFACTURER: Applied Medical Resources Corp, Rancho Santa Margarita, CA, by letter on October 14, 2005. Firm initiated recall is ongoing. REASON: The product is being recalled due to an incorrect component. The incorrect Wound Retractor base was packaged with the kit. PRODUCT: Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system, Recall # Z-0153-06 MANUFACTURER: Recalling Firm: Baxter Healthcare, Renal Division, McGaw Park, IL, by letters dated August 29, 2005. Manufacturer: Mesys Gmbh, Hannover, Germany. Firm initiated recall is ongoing. REASON: A software anomaly that occurs when the Reset Totals option is selected during CVVHD therapy with a diaylsate flow rate of less than 600 mL/hour, or CVVH therapy with a predilution flow rate of less than 600 mL/hour, causes balance alarms without an obvious cause. PRODUCT: Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX, Recall # Z-0154-06 MANUFACTURER: Medrad, Inc., Indianola, PA, by letter dated October 12, 2005. Firm initiated recall is ongoing. REASON: The heat maintainer, an accessory, may overheat and deform the disposable syringe. PRODUCT: a) Boehringer Suction Regulator, Model number: 3704, Recall # Z-0155-06; b) Boehringer Suction Regulator, Model number: 3704D3, Recall # Z-0156-06;c) Boehringer Suction Regulator, Model number: 3714, Recall # Z-0157-06 MANUFACTURER: Boehringer Laboratories, Inc., Norristown, PA, by telephone on July 25, 2005. Firm initiated recall is complete. REASON: Condition exists that prevents complete shutoff of the valve. PRODUCT: ICCG AC-Powered Adjustable Medical Bed, Model Numbers:1102550, 026757, 720-3M-80PR, IH720-3MQS, IH720-3M, 720-3M-76PR, IH720-2M, IHSC900, 026746, SC900-80P, SC90080L, SC900-76L, 720FULL, IHMC2MFP76, IHMC2MF80, IHMC2MF76, IHMC2MFP76, IHMC3MFP80, IHMC3ZP4I6, IHMC2M3ZP41, IHMC23ZP236, IHMC3SP23, 1H3MRFR76, IH3MRFR80, IH3MR2076, IH3MR2080, IH3MR8FR76, IH3MF8FRU6, IH3MR8FR80, IH3MF8FRU, Recall # Z-0158-06 MANUFACTURER: Invacare Corporation, Elyria, OH, by telephone and letter on July 23, 2004. Firm initiated recall is ongoing. REASON: Component Defect. Metal Oxide Varister (MOV) component of the junction box may short circuit with the potential for device failure. PRODUCT: Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550, Recall # Z-0159-06 MANUFACTURER: Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL, by letters dated May 5, 2005. Manufacturer: Baxter Healthcare Corporation, Singapore. Firm initiated recall is ongoing. REASON: A “Check Flange” alarm may occur even though the syringe has been properly loaded into the AS50 Infusion Pump. The false alarm may occur during the syringe loading process or while an infusion is running. Also, the occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates. PRODUCT: Ohmeda Giraffe Spot PT Lite Phototherapy System, Recall # Z-0160-06 MANUFACTURER: Ohmeda Medical, A division of Datex-Ohmeda, Inc., Laurel, MD, by letter on August 5, 2005. Firm initiated recall is ongoing. REASON: Phototherapy medical device may lose its position and can cause a safety hazard to the patient. PRODUCT: a) Cardinal Health Custom Sterile Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; identified by the following catalog numbers: a) Cat. POOCOTFGB - Sterile Ortho Pack b) Cat.SOP22ARCLC - Sterile Arthoscopy Pack c) Cat. SOP30ARCOB - Sterile Knee Arthroscopy Pack d) Cat. SOP30ARCOC - Sterile Knee Arthroscopy Pack e) Cat. SOP30ARKGC - Sterile Arthroscopy Pk f) Cat. SOP30ARMCB - Sterile McCallum Surgical Pack g) Cat. SOP30ARNOA - Sterile Arthroscopy Pack h) Cat. SOP30KANRA - Sterile Knee Arthroscopy Pack i) Cat. SOP30LENHC - Strl Major Lower Extremity Pk j) Cat. SOP30SADTE - Strl Shoulder Arthroscopy Pack k) Cat. SOP30THDTD - Sterile Total Hip Pack l) Cat. SOP30THNOA - Sterile Total Hip Pk m) Cat. SOP30THSJA - Sterile Total Hip Pack n) Cat. SOP30TKSJA - Sterile Total Knee Pack o) Cat. SOP30THVCH - Sterile Total Hip Pack p) Cat. SOP30TKVCE - Sterile Total Knee Pack, Recall # Z-0163-06; b) Cardinal Health Presource PBDS Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; identified by the following catalog numbers: a) Cat. PO23AAMCC - Arthroscopy Kit b) Cat. PO23TKMCC - Total Knee Kit c) Cat. SOP11OPFGB - Ortho Pack d) Cat. SCV48CVJHD - Strl Open Heart Part A & B Pk, Recall # 0164-06 MANUFACTURER: Cardinal Health, McGaw Park, IL, by letter dated October 3,2005. Firm initiated recall is ongoing. REASON: The procedure kits labeled as latex-free may contain a 4’ or 6’ ultra-weave premium elastic bandage containing dry, natural rubber latex. PRODUCT: a) S2 System, Locking Screw Partially Threaded, Catalog No. 1791-5065S to 1791-5120S; Recall # Z-0166-06; b) S2 System, Locking Screw Fully Threaded, Catalog No. 1796-5065S to 1796-5120S, Recall # Z-0167-06; c) S2 System, Condyle Screw, Catalog No. 1795-5090S to 1795-5120S, Recall # Z-0168-06; d) T2 System, Condyle Screw, Catalog No. 1895-5085S to 1895-5120S, Recall # Z-0169-06;e) Gamma System, Cross Screw, Self-Tapping (Cleared under Grosse and Kempf Locking Nail System), Catalog No 3370-5-035 to 3370-5-090, Recall # Z-0170-06 MANUFACTURER: Stryker Howmedica Osteonics Corp, Mahwah, NJ, by letter, on October 4, 2005. Firm initiated recall is ongoing. REASON: Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a potential breach of the sterile barrier. PRODUCT: In2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). For the rapid quantification of hemoglobin A1c in whole blood, Recall # Z-0171-06 MANUFACTURER: Recalling Firm: Provalis Diagnostics, Orlando, FL, by telephone and FAX or email on May 20, 2005. Manufacturer: Provalis Diagnostics Limited, Deeside, UK. Firm initiated recall is complete. REASON: Provalis Diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it HbA1C Test Cartridges. PRODUCT: Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIM method, Recall # Z-0172-06 MANUFACTURER: Recalling Firm: Dade Behring, Inc., Newark, DE, by letter on July 29, 2005. Manufacturer: Aventis Behring Gmbh, Marburg, Germany. Firm initiated recall is ongoing. REASON: Reports of false negative results on Sysmex Coagulation System. PRODUCT: VITROS VANC (vancoymycin) Reagent, REF #680 1709, Recall # Z-0173-06 MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters and e-mail dated October 12, 2005. Firm initiated recall is ongoing. REASON: Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days. CLASS III PRODUCT: Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems; Made in the U.S.A. Recall # Z-0139-06 MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Div, McGaw Park, IL, by letter on September 12, 2005. Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing. REASON: The Spanish language patient operating manual called the Patient At-Home Guide, was not updated when several warnings were added to the English version that may assist the operator in the safe and effective operation of the home dialysis machine. PRODUCT: Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set, Recall #Z-0141-06 MANUFACTURER: Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by FedEx on September 13, 2005. Manufacturer: Integra Neurosciences Ltd, Andover, UK. Firm initiated recall is ongoing. REASON: Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. PRODUCT: BD Bard-Parker Special Surgeon’s Peridontia Blade, Sterile, Single Use, Reorder # 371712, Recall # Z-0152-06 MANUFACTURER: Recalling Firm: Becton Dickinson and Company, Franklin
Lakes, NJ, by letter on June 30, 2005. Manufacturer: Becton Dickinson
Cariba, Las Piedras, PR. Firm initiated recall is complete. PRODUCT: DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm, Catalog Number: 232220, Recall # Z-0161-06 MANUFACTURER: Recalling Firm: Depuy Mitek, a Johnson & Johnson Co., Raynham, MA, by letter on August 9, 2005. Manufacturer: J-PAC, LLC, Somersworth, NH. Firm initiated recall is complete. REASON: Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer. PRODUCT: “Fine Tuning Your Pump” booklet provided with Model MMT-515 and MMT-715 Insulin Infusion Pumps, Recall # Z-0162-06 MANUFACTURER: Medtronic MiniMed, Northridge, CA, by letter on April 27, 2005. Firm initiated recall is ongoing. REASON: The text description of how to perform insulin sensitivity testing and associated worksheet included in the booklet that is shipped with the Paradigm 515 and Paradigm 715 insulin pumps contained a basic flaw in that the blood glucose after the correction should be compared to the target glucose and it says compare to the beginning blood glucose in the procedure. PRODUCT: Biosteon brand HA/PLLA Cross Pin, Model Number 234-500-350, Recall # Z-0165-06 MANUFACTURER: Recalling Firm: Stryker Endoscopy, San Jose, CA, by telephone, letter, and sales representative visit on August 23, 2005. Manufacturer: Biocomposites, Staffordshire, England. Firm initiated recall is complete. REASON: The medical device is misbranded in that the package is labeled as Biosteon Interference Screw in fact contains Biosteon Cross Pin. This mislabeling could disrupt surgery preparation resulting in surgery delay. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 16, 2005: CLASS II PRODUCT: a) Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003, Recall # Z-0098-06;b) Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 04393201001, Recall # Z-0099-06; c) Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001, Recall # Z-0100-06 RECALLING FIRM/MANUFACTURER: Roche Diagnostics Corp., Burlington, NC, by letter dated March 28, 2005. Firm initiated recall is complete. REASON: Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass. PRODUCT: Lifescan OneTouch SureStep Meter Blood Glucose monitoring system, Recall # Z-0101-06 MANUFACTURER: LifeScan, Inc., Milpitas, CA, by letter and telephone on September 9, 2005. Firm initiated recall is ongoing. REASON: The LCD of the OneTouch SureStep Meter may display incorrectly, resulting in missing segments on the display. This display failure may result in patients misreading the blood glucose result, or cause a delay in test interpretation, and could cause delays or mistreatment. PRODUCT: Sopha Medical Vision DST / DST-XL Digital variable angle Nuclear Imaging System. Cameras affected by this safety notice are labeled with the SOPHA MEDICAL logo. STATIF DST and STATIF DST-XL model 100. The label is located on the inner side of the gantry cover. All affected cameras were manufactured prior to 1997 by Sopha Medial (SMV), which was subsequently acquired by GE Healthcare in 2000. Recall # Z-0105-06 MANUFACTURER: Recalling Firm: General Electric Med Systems LLC, Waukesha, WI, by letter dated July 22, 2005. Manufacturer: Sopha Medical Systems, Inc., Cedex, France. Firm initiated recall is ongoing. REASON: Cracked welds on the main rotation shaft could potentially lead to the collapse of the gantry yokes that support the detectors. PRODUCT: a) Meridian PA Femoral Stem, Catalog No --Description -- # of
Lots: 6261-0-001, Meridian PA Hip Stem #00/9, 25 lots; 6261-0-002,
Meridian PA Hip Stem #00/10, 26 lots; 6261-0-003, Meridian PA Hip Stem
#1/11MM, 107 lots; 6261-0-004, Meridian PA Hip Stem #2/10MM, 16 lots;
6261-0-005, Meridian PA Hip Stem #2/12MM, 109 lots; 6261-0-006, Meridian
PA Hip Stem #3/11MM 150 lots; 6261-0-007, Meridian PA Hip Stem #3/13MM,
256 lots; 6261-0-008, Meridian PA Hip Stem #4/12MM, 115 lots; 6261-0-009,
Meridian PA Hip Stem #4/14MM, 194 lots; 6261-0-010,Meridian PA Hip Stem
#5/13MM, 139 lots; 6261-0-011, Meridian PA Hip Stem #5/15MM, 104 lots;
6261-0-012, Meridian PA Hip Stem #6/14MM, 96 lots; 6261-0-013, Meridian PA
Hip Stem, #6/16MM, 73 lots; 6261-0-014, Meridian PA Hip Stem, #7/15MM, 21
lots; 6261-0-015, Meridian PA Hip Stem, #7/17MM, 25 lots; 6261-0-016,
Meridian PA Hip Stem, #8/16, 16 lots; 6261-0-017, Meridian PA Hip Stem,
#8/18, 15 lots, Recall # Z-0106-06;b) Meridian ST Femoral Stem, Catalog
#---Description -- # of lots: 6265-0-005, Meridian ST Hip Stem #2/12MM, 13
lots; 6265-0-006, Meridian ST Hip Stem #3/11MM, 3 lots; 6265-0-007,
Meridian ST Hip Stem #3/13MM, 31 lots; 6265-0-009, Meridian ST Hip Stem,
#4/14MM, 4 lots; 6265-0-011, Meridian ST Hip Stem, no # 15 lots;
6265-0-013, Meridian ST Hip Stem #6/16MM, 7 lots, MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on August 24, 2005. Manufacturer: Stryker Ireland, Ltd., Carrigtohill, Ireland. Firm initiated recall is ongoing. REASON: The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. PRODUCT: The Lysus® Infusion System - Catheter Interface Cable. The Lysus Infusion System employs high frequency, low power ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) The Lysus® Infusion System consists of three main components, a single use Lysus® Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus® Infusion Catheter System, Part number: 3929-001 Catalog number: 700-10301, Recall # Z-0110-06 MANUFACTURER: Ekos Corp., Bothell, WA, by visits starting on September 21, 2004. Firm initiated recall is complete. REASON: The 100V board in the catheter interface cable pod failed during use. The PT-3 control unit would not recognize the catheter interface cable. PRODUCT: Lysus® Infusion System - Lysus Drug Delivery Catheter: The Lysus Infusion System employs high frequency, low power ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) The Lysus® Infusion System consists of three main components, a single use Lysus® Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus® Infusion Catheter System. Catalog # & Part #: 500-52112, 3383-002; 500-52124, 3393-004; 500-52124, 3393-006; 500-52150, 3393-007, Recall # Z-0111-06 MANUFACTURER: Ekos Corp., Bothell, WA, by letters on November 22, 2004 and by visit on March 10, 2005. Firm initiated recall is complete. REASON: During two separate procedures, the user experienced difficulty placing the EKOS ultrasound core (USC) into the EKOS drug delivery catheter (DDC) when transiting tight bend radii; specifically the aortic bifurcation. In one case, the USC fractured within the DDC when the user attempted to withdraw the USC after resistance was encountered. PRODUCT: a) QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series, part number: 3006570-006 and below, Recall # Z-0116-06; b) Standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series. Part number: 3006228-013 and below, Recall # Z-0117-06 MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA,
by letters on September 2, 2005. Firm initiated recall is ongoing. PRODUCT: Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile, Recall # Z-0124-06 MANUFACTURER: Remington Medical Inc., Alpharetta, GA, by sales personnel on August 31, 2005. Firm initiated recall is ongoing. REASON: The vector selector has an electrical design flaw which prevents RV pacing. PRODUCT: Bari Maxx II, KCI’s BariMaxx II bariatric bed, P/N 310611, November 2001, Product Code 80 FNL, Recall # Z-0129-06 MANUFACTURER: Kinetic Concepts, Inc, San Antonio, TX, by letter on August 16, 2005. Firm initiated recall is complete. REASON: Design change to upgrade reliability of powered adjustable bed. PRODUCT: Hemosense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21, Recall # Z-0132-06 MANUFACTURER: Hemosense, Inc., San Jose, CA, by letters and telephone on September 7, 2005. Firm initiated recall is ongoing. REASON: A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition. 7.5' test message under a particular use condition." name=prdReason0 PRODUCT: a) LifeShield Latex-Free HEMA Blood PlumSet; Nonvented, 100 inch, with 210 Micron Filter, Prepierced Injection Site and Option-Lok, Dual Channel Capped Secondary Port; List 11235-03, Recall # Z-0133-06; b) LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filter, Prepierced Injection Site, Prepierced Secondary Port and Option-Lok for use with Plum Series Infusers; list 11664-03, Recall # Z-0134-06; c) LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filter, Inline Dual Channel Cassette, 2 Clave Ports and Option-Lok for use with Plum Series Infusers; list 12259-02, Recall # Z-0135-06 MANUFACTURER: Recalling Firm: Hospira Inc., Lake Forest, IL, by letters dated September 29, 2005. Manufacturer: Abbott Laboratories de Costa Rica S.A., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing. REASON: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow. PRODUCT: Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512, Recall # Z-0136-06 RECALLING FIRM/MANUFACTURER: Nichols Institute Diagnostics, San Clement, CA, by fax and letter on September 29, 2005. Firm initiated recall is ongoing. REASON: Some units in Lot 30-500953 (Calibration Verifier 2) are mislabeled as Calibration Verifier 3. Some units of Lot 30-500953 (Calibration Verifier 3) are mislabeled as Calibration Verifier 2. PRODUCT: Vitros ECi Immunodiagnostic System, sold as Catalog #863 3893; Catalog #192 2814 (Vitros ECiQ), and Catalog #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units, Recall # Z-0137-06 MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated September 29, 2005. Firm initiated recall is ongoing. REASON: When using Vitro ECi Immunodiagnostic System with Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs, results of the 1st of two required re-test replicates may be negatively biased. PRODUCT: Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735, Recall # Z-0138-06 MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on October 3, 2005. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing. REASON: If the recommended workflow is not followed and the worksheets are printed after moving the patient table out of isocenter, the offset values will be incorrect. This could result in a biopsy being performed at an incorrect location and presents the possibility of an inconclusive diagnosis. The recalling firm issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions MR034/05/S. The letter re-emphasizes the importance of printing the offset values on the worksheet prior to moving the patient table and in accordance with the User's Manual. PRODUCT: Optimus 30, Recall # Z-1084-06 MANUFACTURER: Philips Ultrasound, Inc., Bothell, WA, by visit on/about February 24, 2004. Firm initiated recall is ongoing. REASON: Systems do not comply with the labeling performance standards. CLASS III PRODUCT: Tru-Link DIN unshielded ECG cable, 5-lead, Part number: 012-0123-01, Recall # Z-0063-06 MANUFACTURER: Spacelabs Medical Inc, Issaquah, WA, by letter on September 16, 2005. Firm initiated recall is ongoing. REASON: ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect. PRODUCT: Accumetrics VerifyNow Instrument, printe power supply, Part number: 29001, Recall # Z-0102-06 MANUFACTURER: Accumetrics Inc., San Diego, CA, by letters on September 13, 2005. Firm initiated recall is ongoing. REASON: In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply. PRODUCT: a) Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T, Recall # Z-0103-06; b) Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4, Recall # Z-0104-06 MANUFACTURER: Medical Components, Inc., dba MedComp, Harleysville, PA, by telephone on September 15, 2005. Firm initiated recall is ongoing. REASON: The product is labeled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. PRODUCT: a) Arcadis Varic Mobile X-Ray System. Model number 8080017, Recall # 0118-06; b) Arcadi Orbic Mobile X-Ray System. Model number 8081080, Recall # Z-0119-06; c) Siremobil Compact Mobile X-Ray System. Model number 3776494, Recall # 0120-06; d) Siremobil Compact L Mobile X-Ray System. Model number 3780629, Recall # 0121-06; e) Siremobil Iso-C Mobile X-Ray System. Model number 2829450, Recall # 0122-06; f) Powermobil Mobile X-Ray System, Model number 2830011, Recall # Z-0123-06 MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by visit beginning on August 11, 2005. Firm initiated recall is ongoing. REASON: Screws may become loose and fall into the OR field during surgery. PRODUCT: Tosoh brand Glycohemoglobin Alc Controls I & II, Catalog Number: 992133, Recall # Z-0131-06 MANUFACTURER: Recalling Firm: Tosoh Bioscience, Inc., South, San
Francisco, CA, by letter on August 18, 2005. Manufacturer: Aalto
Scientific, Ltd., Carlsbad, CA. Firm initiated recall is ongoing. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 9, 2005: CLASS II PRODUCT: Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300, Recall # Z-0112-06 MANUFACTURER: Recalling Firm: Boston Scientific, San Jose, CA, by letters on April 1, 2005. Manufacturer: Boston Scientific, Cedex, France. Firm initiated recall is ongoing. REASON: The device has the potential for overheating its transformer and has the potential for fire hazard. PRODUCT: a) K 520411-2, Hercep Test, 35 Test, HER2, Protein, Recall # Z-0113-06; b) K 520711-2, Hercep Test, 35 Test, HER2, Protein, Recall # Z-0114-06 MANUFACTURER: Recalling Firm: Dakocytomation California, Inc., Carpinteria, CA, by letter dated September 29, 2005. Manufacturer: Dakocytomation, Denmark. Firm initiated recall is ongoing. REASON: Formulation error in the Visualization Reagent (vial 3) component contained in Hercep Test Kits. The error was in the concentration of Polyethylene Glycol contained in the formulation. PRODUCT: Product names: a) Alginate Dental Impression Material Regular Set, Cinnamon Flavor, Pink Color b) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color c) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color Dustless d) Alginate Dental Impression Material Regular Set, Cherry Flavor, No color e) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color f) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color, Dustless g) Alginate Dental Impression Material Fast Set, Cherry Flavor, No color. All are varieties of alginate dental impression powder packaged in aluminum foil pouches labeled as containing approximately 454 grams (one pound), or in the case of one foreign account, packaged in unlabeled 25 lb. and 39 lb. bulk containers. The alginate impression material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient’s teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. This product was cleared as a prescription device; however, it is not labeled as such. Recall # Z-0128-06 MANUFACTURER: Rite-Dent Manufacturing Corp., Hialeah, FL, by letters during the week September 26, 2005. Firm initiated recall is ongoing. REASON: At least two of the ingredients used in the production of these products were not intended for human use. The ingredients are not listed in the master formula for these products nor are they listed on the ingredients list. CLASS III PRODUCT: BirthNet OB Data Management System 91861, Recall # Z-0115-06 MANUFACTURER: Spacelabs Medical Incorporated, Issaquah, WA, by letters on October 13, 2004. Firm initiated recall is ongoing. REASON: Potential for incorrect weight to be displayed. PRODUCT: Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 individually packaged Obturators. Sterile EO. Single use, Recall # Z-0125-06 MANUFACTURER: St. Jude medical, DAIG Division, Inc., Minnetonka, MN, by letter dated September 20, 2005. Firm initiated recall is ongoing. REASON: A lot of product contains a 6F Obturator with a hub that is incorrectly marked as 5 instead of the appropriate 6. The Obturator is correctly sized (6F) per the labeling on both the sterile bag and shelf carton. PRODUCT: TC-Plus Solution Femoral Component, model 21028, Femoral component, right, size 8, Recall # Z-0126-06 MANUFACTURER: Recalling Firm: Plus Orthopedics USA, San Diego, CA. by letter on July 23, 2005. Manufacturer: Plus Endoprothetik AG, Rotkreuz, Switzerland. Firm initiated recall is complete. REASON: Labeling discrepancy. PRODUCT: AMPLATZER Vascular Plug, Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. A stainless steel micro screw is welded to one of the platinum marker bands, which allows attachment to the 135 cm long deliver cable. The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments, Recall # Z-0127-06 MANUFACTURER: AGA Medical Corporation, Golden Valley, MN, by letters dated September 1, 2005. Firm initiated recall is ongoing. REASON: Five lots of AMPLATZER Vascular Plugs were sterilized in a load that was not validated for the AMPLATZER Vascular Plug. However, only three of those five lots were distributed. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 2, 2005: CLASS I PRODUCT: a) Enteryx Procedure Kit, Order No: M00572600 --US and M00572500 --OUS, Recall # Z-0040-06; b) Enteryx Injector Single Pack Order Number: M00572650 -US and M00572630 -OUS, Recall # Z-0041-06 MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on September 23, 2005. Manufacturer: Life Science Outsourcing, Inc., Brea, CA. Firm initiated recall is ongoing. REASON: Incorrect implantation may cause serious health complications. A transmural injection can result in an injection directly into a vital organ including the aorta and serious patient injury and death could occur. CLASS II PRODUCT: Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553, Recall # Z-0089-06 MANUFACTURER: Medrad, Inc., Indianola, PA, by an Urgent Medical Device Field Correction notice dated October 7, 2005 and October 13, 2005. Firm initiated recall is ongoing. REASON: Overhead system can fall due to the failure of a retaining ring. PRODUCT: Premicath 28G PICC Catheter, Recall # Z-0090-06 MANUFACTURER: Recalling Firm: Vygon Corporation, Norristown, PA, by letter on June 27, 2005. Manufacturer: Vygon GmbH & Co., Aachen, Germany. Firm initiated recall is complete. REASON: Guidewire protruding from tip of the catheter. PRODUCT: Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical screws, item number 02.00020.039, Recall # Z-0091-06 MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated September 30, 2005. Firm initiated recall is ongoing. REASON: The calibrations on the reamers may lead to inaccurate reaming depth when used in accordance with the published surgical technique. PRODUCT: Sienet Cosmos. Radiological Image Processing. Model number 10018971, Recall # Z-0092-06 MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by Customer Safety Advisory dated September 22, 2005. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing. REASON: Reference lines appear above actual position. PRODUCT: a) Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001), Recall # Z-0093-06; b) Tecnis Multifocal Silicone Posterior Chamber IOLs (Model: ZM900), Recall # Z-0094-06; c) CeeOn EDGE Silicone Posterior Chamber IOLs (Models 911A and 913A), Recall # Z-0095-06; d) CeeOn Heparin Surface Modified (HSM) PMMA One-Piece Posterior Chamber- IOLs (Models:722C, 722Y, 811C, 812C and 812CU), Recall # Z-0096-06; e) CeeOn Heparin SurfaceModifie (HSM) PMMA One-Piece Anterior Chamber IOLs (Model: HSM65),Recall Z-0097-06 MANUFACTURER: Recalling Firm: Advanced Medical Optics, Inc., Santa Ana, CA, by letter beginning on October 5, 2005. Manufacturer: Amo Groningen, Groningen, CA. Firm initiated recall is ongoing. REASON: A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 26, 2005 CLASS I PRODUCT: VeriCal Calibrator Set, Recall # Z-0032-06 MANUFACTURER: Biomerieux, Inc., Durham, NC, by letter, on/about August 31, 2005. Firm initiated recall is ongoing. REASON: The product is being recalled due to mis-assignment of ISI values associated with VeriCal use. This could lead to inaccurate patient INR results. PRODUCT: a) FreeStyle FLASH Blood Glucose Monitoring System, Recall # Z-0042-06; b) Tracker Blood Glucose Monitoring System, Recall # Z-0043-06; c) Xceed Blood Glucose Monitoring System, Recall # Z-0044-06; d) ReliOn Ultima Glucose Monitoring System, Recall # Z-0045-06; e) Kroger Glucose Monitoring System, Recall # Z-0046-06; f) RiteAid Glucose Monitoring System, Recall # Z-0047-06; g) Liberty Glucose Monitoring System, Recall # Z-0048-06; h) Boots Glucose Monitoring System, Recall # Z-0049-06; i) Optium Glucose Monitoring System, Recall # Z-0050-06; j) Xtra Classic Glucose Monitoring System, Recall # Z-0051-06; k) Easy Glucose Monitoring System, Recall # Z-0052-06; l) SofTrac Glucose Monitoring System, Recall # Z-0053-06; m) FreeStyle Glucose Monitoring System, Recall # Z-0054-06 MANUFACTURER: Abbott Diabetes Care, Inc., Alameda, CA, by letter, on June 7, 2005, and by a flyer in Precision Xtra and FreeStyle meter kits. Firm initiated recall is ongoing. REASON: User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. Class II PRODUCT Nichols Advantage QuiCk-Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045, Recall # Z-0056-06 MANUFACTURER: Nichols Institute Diagnostics, San Clemente, CA, by letter on April 14, 2005. Firm initiated recall is ongoing. REASON: Controls were out of specification range. PRODUCT: Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L 1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R PMA; L-1189-04-S D17TCJLRT 35Q-73R PMA; L-1189-15-S D71TCB5L252RT 35Q-17Q EXPORT; L-1189-16-S D71TCD5L252RT 35Q-37Q EXPORT; L-1189-17-S D71TCF5L252FT 35Q-57Q EXPORT; L-1189-03-S D71TFL252RT 35R-53R EXPORT; L-1192-03-S D71TFL252RT 35R-53R EXPORT; L-1192-15-S D71TB5L252RT 35R-17R EXPORT; L-1192-16-S D7ITD5L252RT 35R-37R EXPORT; L-1189-02-SI D17TCDLRTI N/A IDE; L-1189-15-SI D71TCB5L252RTI N/A IDE; L-1189-16-SI D71TCD5L252RTI N/A IDE; L-1189-17-SI D71CF5L252RTI N/A IDE Navistar LABEL US Part Number# EU CATALOG # L-1192-17-S D71TF5L252RT 35R-57R EXPORT; L-1197-14-S NI75TCBH 34H-17M PMA; L-1197-15-S NI75TCCH 34H-27M PMA; L-1197-16-S NI75TCDH 34H-37M PMA; L-1197-17-S NI75TCFH 34H-57M PMA; L-1197-18-S NI75TCJH 34H-J7M PMA; L-1208-05-S NS75TBCT252HS 34G-17M PMA; L-1208-06-S NS75TCCT252HS 34G-27M PMA; L-1208-07-S NS75TDCT252HS 34G-37M PMA; L-1208-08-S NS75TFCT252HS 34G-57M PMA; L-1197-14-SI NI75TCBHI N/A IDE; L-1197-15-SI NI75TCCHI N/A IDE; L-1197-16-SI NI75TCDHI N/A IDE; L-1197-17-SI NI75TCFHI N/A IDE; L-1197-18-SI NI75TCJHI N/A IDE; L-1208-05-SI NS75TBCT252HSI N/A IDE; L-1208-06-SI NS75TCCT252HSI N/A IDE; L-1208-07-SI NS75TDCT252HSI N/A IDE; L-1208-08-SI NS75TFCT252HSI N/A IDE, Recall # Z-0057-06 MANUFACTURER: Biosense Webster, Inc., Irwindale, CA, by letters dated August 8, 2005. Firm initiated recall is ongoing. REASON: Increased complaints regarding catheters with leaks and flow obstruction. PRODUCT: a) Scorpio Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No. 70-4107L. 1 each to a package, Recall # Z-0058-06; b) Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. 1 each to a package, Recall # Z-0059-06 MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on August 11, 2005. Firm initiated recall is ongoing. REASON: The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa. PRODUCT: T2 Recon Nail System, Recall @ Z-0060-06 MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on August 12, 2005. Manufacturer: Stryker Trauma, Kiel, Germany. Firm initiated recall is ongoing. REASON: The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility. PRODUCT: Baxter's Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product code 2M5013 and Point of Care - product code 2M5014; made in Canada, Recall # Z-0061-06 MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated August 29, 2005. Manufacturer: Baxter Healthcare Corp/Patient Care System, Toronto, Canada. Firm initiated recall is ongoing. REASON: If an administrative user modifies any of the seven pre-defined Monitoring Parameters when they are attached to a medication in the drug |