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Recall Archives 14 FDA RecallsJanuary 7, 2004 - June 30, 2004
Attention all mdi Clients:The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 30, 2004: CLASS I MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by bulletin dated March 5, 2004. Firm initiated recall is ongoing. PRODUCT: a) Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001. Recall # Z-0996-04; b) Tecan clinical workstation; Tecan Genesis 150/8 TCW front end COBAS (FEC), Roche catalog number 0360053001. Recall # Z-0997-04; c) Tecan clinical workstation; Tecan Genesis 150 back end, Roche catalog number 03585352001. Recall # Z-0998-04. REASON: If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results. MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN., by press release on May 7, 2004, and letter dated May 5, 2004. Firm initiated recall is complete. PRODUCT: a) Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001. Recall # Z-0999-04; b) Tecan clinical workstation; 10-415 Tecan Genesis 150 front end, Roche catalog number 03585379001. Recall # Z-1000-04; Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 03600530001. Recall # Z-1001-04. REASON: Tecan software has the potential to match the patient with a different patientís test result. CLASS II MANUFACTURER: Accumetrics, Inc., San Diego, CA, by letters on May 10, 2004. Firm initiated recall is ongoing. PRODUCT: VerifyNow Asprin Assay Kit Part No. 85034. Recall # Z-1018-04. REASON: Test results too low in control. MANUFACTURER: Sechrist Industries, Inc., Anaheim, CA, by letter on May 20, 2004. Recall notification contains a test method to be used to identify defective units. Return notification that ventilator is defective will result in replacement of the electronic manometer. Firm initiated recall is ongoing. PRODUCT: Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI. Recall # Z-1032-04. REASON: Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all. MANUFACTURER: Cardiac Science, Inc., Minneapolis, MN, by letter dated May 24, 2004. FDA initiated recall is ongoing. PRODUCT: a) Power Heart AED Automatic External Defibrillator, Model 9200 RD. Recall # Z-1033-04; b) Power Heart Automatic External Defibrillator, Model 9210 RD. Recall # Z-1034-04. REASON: Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 23, 2004: CLASS I MANUFACTURER: Roche Diagnostics Corp, Indianapolis, IN, by letter dated May 5, 2004 and press release on May 7, 2004. Firm initiated recall is ongoing. PRODUCT: COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog number 04498984001. Recall # Z-1021-04. REASON: The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient. MANUFACTURER: Tecan US Inc., Durham, NC, by letter on May 3, 2004. Firm initiated recall is ongoing. PRODUCT: Tecan Clinical Workstations with Robonet software. Recall # Z-1022-04. REASON: Tecan software has the potential to match the patient with a different patients test results. CLASS II MANUFACTURER: MinXray, Inc., Northbrook, IL, by telephone beginning on June 9, 2004. Firm initiated recall is ongoing. PRODUCT: X-ray systems, model numbers: P200R24 and P200R40. Recall # Z-0985/0986-04. REASON: The units user manual had missing or inadequate information. MANUFACTURER: Radionics, Inc., Burlington, MA, by telephone and letters dated May 25, 2004. Firm initiated recall is complete. PRODUCT: Radionics Head and Neck Localizer (HNL), Version B. Recall # Z-1020-04. REASON: Software may provide inaccurate coordinates and cause mistreatment. MANUFACTURER: CAS Medical Systems, Inc., Branford, CT, by telephone and letter dated May 24, 2004. Firm initiated recall is ongoing. PRODUCT: Cardio Respiratory Monitor with Oximax technology with software version 5.0, Model 511. Recall # Z-1023-04. REASON: Device may not alarm for %SpO2 value limit violations if a specific feature is enabled. MANUFACTURER: Medtronic Vascular, Santa Rosa, CA, by letter and telephone on June 8, 2004. Firm initiated recall is ongoing. PRODUCT: NC Stormer Zipper MX Balloon Dilation Catheter, a Percutaneous Transluminal Coronary Angioplasty system in sterile pouch. Recall # Z-1024-04. REASON: Medical device for which sterility may be compromised because of improper seal. MANUFACTURER: Ascension Orthopedics, Inc., Austin, TX, by letter beginning in October 2003. Firm initiated recall is complete. PRODUCT: Hitachi Ascension PIP instrument tray base. Recall # Z-1025-04. REASON: Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility. MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letters on September 4, 2003. PRODUCT: Synchron Systems Acetaminophen Reagent, part No. 472169. Recall # Z-1026-04. REASON: Firm shortened calibration frequency to 7 days from 14 days. MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letters on February 14, 2003. Firm initiated recall is complete. PRODUCT: DL 2000 Data Manager. Recall # Z-1027-04. REASON: Software defect. The type of results affected were replicate type results for a single sample transmitted within the same data stream. MANUFACTURER: Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letter on May 13, 2004. Firm initiated recall is ongoing. PRODUCT: Trolley for Intera/NT MRI System. Recall # Z-1028-04. REASON: Patient and MRI tabletop may fall if the tabletop is not positioned correctly on the MRI trolley. MANUFACTURER: Horizon Medical Products, Inc., Manchester, GA, by letter on May 28, 2004. Firm initiated recall is ongoing. PRODUCT: a) Circle CĆ Dual Lumen Acute Hemodialysis/ Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm, Sterile. The product is a clear rigid plastic surgical tray containing components required for implantation. Components of the inner tray are in a separate sterile pouch. The tray and components are then sealed in an outer clear plastic pouch. Catalog #DLC600-64C. Recall # Z-1029-04; b) Circle CĆ Dual Lumen Acute Hemodialysis/ Apheresis Catheter Surgical Tray, DLC-600TEC, DCL-800TEC 12 Fr. x 20.3cm. The product is a clear rigid plastic surgical tray containing components required for implantation. Components of the inner tray are in a separate sterile pouch. The tray and components are then sealed in an outer clear plastic pouch. Recall # Z-1030-04. REASON: The products have a potential defective seal that closes the productís OUTER POUCH. The surface of the INNER TRAY may no longer be sterile. MANUFACTURER: Toshiba American Med System, Inc., Tustin, CA, by letters on March 17, 2004. Firm initiated recall is ongoing. PRODUCT: Computed Tomography, Models TSX-101A and TSZ-021A. Recall # Z-1031-04. REASON: Erroneous patient data is entered. Previous patientís demographics are recorded. CLASS III MANUFACTURER: American Medical Systems, Minnetonka, MN, by telephone on July 28, 2003. Firm initiated recall is complete. PRODUCT: Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1. Recall # Z-1019-04. REASON: Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 16, 2004: CLASS II MANUFACTURER: Lumend Inc, Redwood City, CA, by telephone on May 18, 2004. Firm initiated recall is complete. PRODUCT: LuMend brand percutaneous catheter .35" R in plastic sealed bag, sterilized with ethylene oxide gas. Recall # Z-0995-04. REASON: Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio. MANUFACTURER: Acist Medical Systems, Eden Prairie, MN, by telephone on May 19, 2004. Firm initiated recall is ongoing. PRODUCT: AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System. Recall # Z-1002-04. REASON: Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile. MANUFACTURER: Hitachi Medical Systems America Inc, Twinsburg, OH, by letter on May 7, 2004 and May 25, 2004. Firm initiated recall is ongoing PRODUCT: Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM Service Pack 1 and EZU-FC5W. Recall # Z-1005-04. REASON: Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in misdiagnosis and delay in treatment. MANUFACTURER: Biosense Webster, Inc., Irwindale, CA, by letter on May 21, 2004. Firm initiated recall is ongoing. PRODUCT: Quickcable Autoclaveable Cable Electrode Cable. Recall # Z-1006-04. REASON: Mislabeling. MANUFACTURER: Spacelabs Medical, Issaquah, WA, by letters on May 7, 2004, and May 14, 2004. Firm initiated recall is ongoing. PRODUCT: a) Ultraview Universal Clinical Workstation Model 90385. Recall # Z-1007-04; b) Ultraview 1700 Monitor Model 90387. Recall # Z-1008-04. REASON: Potential for telemetry channels to drop off display. MANUFACTURER: Cobe Cardiovascular, Inc , Arvada, CO, by telephone on May 25, 2004 and by letter on June 3, 2004. Firm initiated recall is ongoing. PRODUCT: Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt. Catalog # 027770201. Recall # Z-1009-04. REASON: Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia. MANUFACTURER: Baxter Healthcare Renal Div, Mc Gaw Park, IL, by letters dated May 24, 2004. Firm initiated recall is ongoing. PRODUCT: a) HomeChoice and Yume Automated Peritoneal Dialysis Systems; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R. Recall # Z-1012-04; b) HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R. Recall # Z-1013-04. REASON: A software defect could result in a patient experiencing an overfill with software versions 8.5 and higher. The possibility of an overfill can occur when the Initial Drain Alarm Volume is set to OFF and a change to the volume is made at the Verify I-DRAIN:XXXXML prompt. MANUFACTURER: GE Medical Systems Information Technologies, Tampa, FL, by letter on January 27, 2004. Firm initiated recall is complete. PRODUCT: Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated protocol converter used to convert the serial data from a DINAMAP Monitor to that of the APEXPRO telemetry transmitter. Recall # Z-1015-04. REASON: The potential exists for external electrical noise to be processed as irregular pacing thereby masking potential asystole events. MANUFACTURER: Smiths Medical ASD, Inc, Keene, NH, by letter, dated May 21, 2004. Firm initiated recall is ongoing. PRODUCT: a) Portex Inner Cannula for Tracheostomy Tube Size 7.0 mm, REF Code 566070. Recall # Z-1016-04; b) Portex Inner Cannula for Tracheostomy Tube size 8.0 mm, REF Code 566080. Recall # Z-1017-04. REASON: Incompatible products may cause potential trachea trauma. MANUFACTURER: Wilson-Cook Medical Inc, Winston Salem, SC, by letters on May 26, 2004. Firm initiated recall is ongoing. PRODUCT: Nasal Jejunal Feeding Tube, Tube Diameter: 10 FR. Tube Length: 240CM., Disposable Single Use Only, Rx Only. Recall # Z-1003-04. REASON: The nasal transfer tube may be missing from the package of the affected lot. MANUFACTURER: Zimmer Inc. Warsaw, IN, by letters dated March 16, 2004. Firm initiated recall is ongoing. PRODUCT: M/DN Intramedullary Fixation Humeral Nail. Catalog no. 00-2254-195-09. Recall # Z-1004-04. REASON: One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation. MANUFACTURER: Encore Medical, LP, Austin, TX, by letters on May 10, 2004. Firm initiated recall is ongoing. PRODUCT: a) Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Catalog number 324-01-106. Recall # Z-1010-04; b) 3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Catalog number 333-02-106; Recall # Z-1011-04. REASON: Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 9, 2004: CLASS II MANUFACTURER: Medstone International Inc., Aliso Viejo, CA, by letter and service representative visit beginning on May 21, 2004. Firm initiated recall is ongoing. PRODUCT: STS-T Mobile X-Ray System. Recall # Z-0884-04. REASON: The identification and certification labels were inadequate or missing. MANUFACTURER: Changchun New Industries Optoelectronics Tech, Co., Ltd., Changchun, China, by letter beginning on May 16, 2004. Firm initiated recall is ongoing. PRODUCT: Laser System, model CNI GLP-III green laser pointer. Use for industrial, scientific and research purposes. Recall # Z-0956-04. REASON: The laser product was found to be noncompliant with the laser product report. MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on or about April 20, 2004. Firm initiated recall is ongoing. PRODUCT: Coulter AcT 5diff Autoloader (AL) Hematology Analyzer. Recall # Z-0987-04. REASON: Software anomaly causes sample results to be not credible, reported as ě0î or left blank. The next sample will also be incorrectly reported for the same parameter. MANUFACTURER: Cardiac Science, Inc., Irvine, CA, by letter dated May 10, 2004. Firm initiated recall is ongoing. PRODUCT: a) Power Heart AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9142. Recall # Z-0990-04; b) FirstSave AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9143. Recall # Z-0991-04. REASON: Some of the recalled defibrillator batteries contain an incorrect fuse, which could open resulting in a defibrillator, which will not work CLASS III MANUFACTURER: Baxter Healthcare Corp., Round Lake, IL, by letters dated April 30, 2004. Firm initiated recall is ongoing. PRODUCT: a) Compounding Brochure titled ěNutrition Compounding Simplifiedî, Lit #800415, print date January 2002; the brochure is applicable to the Automix Plus High Speed Compounder System, product 2M8075, the Automix High Speed Compounder System, product 2M8077, the Automix 3+3 Compounder System, product 2M8286, the Automix 3+3 Compounder with Accusource Monitoring System, product 2M8287, the Micromix Compounder System, 1.0 mL, product 2M8290, and the Micromix Compounder System, 0.3 mL, product 2M8290L; Recall # Z-0988-04; b) Micromix Compounder Implementation Guide; this guide is distributed by Professional Services as part of the training classes for new Micromix Compounder customers. Recall # Z-0989-04. REASON: The promotional material for the Automix/Accusource and Micromix compounders and Micromix Compounder Implementation Guide contain an incomplete accuracy statement regarding the delivery of each ingredient by the compounders. MANUFACTURER: R & D Systems, Inc., Minneapolis, MN, by letters dated April 15, 2004. Firm initiated recall is ongoing. PRODUCT: ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials; and Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High, in vials. Recall # Z-0992-04. REASON: Clots in hematology controls resulted in low red blood cell counts when used in blood analyzers because control values were outside the expected range due to the clotting which took place after manufacturing. MANUFACTURER: Fujifilm Medical System USA, Inc., Stamford, CT, by letter dated May 5, 2004. Firm initiated recall is ongoing. PRODUCT: Fuji Flash IIP and CR-IR346CL Consoles. Recall # Z-0993-04. REASON: Software: Incorrect measurement of objects within a CR image. MANUFACTURER: Howmedica Osteonics Corp., Mahwah, NJ, by letters on March 31, 2004. Firm initiated recall is ongoing. PRODUCT: T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035. Recall # Z-0994-04. REASON: Targeting device may become distorted upon repeated autoclaving. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 2, 2004: CLASS I MANUFACTURER: Arjo, Inc., Roselle, IL, by letters dated April 30, 2004. Firm initiated recall is ongoing. PRODUCT: Minstrel Patient Lift; a non-AC-powered patient lift; model numbers HMB001-US and HMB002-US (with scale). Recall # Z-0970-04. CLASS II MANUFACTURER: Eastman Kodak Co., Rochester, NY, by Field Representatives on February 20, 2004. Firm initiated recall is complete. PRODUCT: Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system 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-0728-04. REASON: Defective component in overhead tube support balancer may cause the suspended load to fall. MANUFACTURER: Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letters on April 15, 2004. Firm initiated recall is ongoing. PRODUCT: Xcelera System, image processing, radiological. Recall # Z-0973-04. REASON: Potential for the image data to be erased from the long term archive MANUFACTURER: Fischer Imaging Corp., Denver, CO, by letter on April 23, 2004. Firm initiated recall is ongoing. PRODUCT: VersaRad/Traumex General Radiographic System. Recall # Z-0974-04. REASON: Two of the four T-nuts that connect the transverse rail to the "U" arm and transverse rails could fall and cause serious injury. MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter and telephone on May 6, 2004. Firm initiated recall is ongoing. PRODUCT: Customized Automation Centrifuge, First and Second Generation. Recall # Z-0975-04. REASON: Centrifuge loss of containment with potential for injury or exposure to biohazard among lab workers. MANUFACTURER: Varian Medical Systems, Charlottesville, VA, by letters on May 4, 2004. Firm initiated recall is ongoing. PRODUCT: VariSource High Dose Rate Afterloader, Models 200, 200t, and ID series. Recall # Z-0976-04. REASON: Manufacturer of brachytherapy instrument issued a Customer Technical Bulletin to clarify instructions for use of the radiation treatment medical device by healthcare practitioners. Excessive turning of the hand wheel on VariSource 200, 200t and ID model after loaders when the active wire is parked can cause the active wire to become dislodged from the shielding. MANUFACTURER: Baxa Corp., Englewood, CO, by telephone, fax, and letter beginning April 30, 2004. Firm initiated recall is ongoing. PRODUCT: a) Exacta-Mix Valve Set, Primary Valve with Detachable Pump Tube. Recall # Z-0978-04; b) Exacta-Mix Valve Set, Secondary Valve Assembly. Recall # Z-0979-04; c) Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembly. Recall # Z-0980-04; d) Exacta-Mix Valve Set, Six Inlet, Tubing Kit. Recall # Z-0981-04; e) Exacta-Mix Valve Set, Primary Valve Assembly. Recall # Z-0982-04; f) Exacta-Mix Valve Set, Primary Valve Assembly. Pediatric. Recall # Z-0983-04; g) Exacta-Mix Valve Set, Primary Valve Assembly. Recall # Z-0984-04. REASON: A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery. CLASS III MANUFACTURER: Mentor Texas, Inc., Irving, TX, by letters on December 16, 2003 and February 6, 2004. Firm initiated recall is complete PRODUCT: Mentor Smooth Round Becker 50 Expander, dome part number 350-DOMPK. Recall # Z-0977-04. REASON: Device was distributed without the dome part accessory. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 26, 2004: CLASS II MANUFACTURER: Dynarex Corp., Orangeburg, NY, by letters on May 10, 2004. FDA initiated recall is ongoing. PRODUCT: 100 Sheer Plastic Spot Bandages, 7/8& quot; Dia. (22 mm). Reorder No. 3607. Sterile with non-stick pad. 100% Latex Free Bandage & Wrapper. 48 boxes of 100 bandages per case. Device Listing # E177598.510 (k) Exempt. Recall # Z-0951- REASON: Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex. MANUFACTURER: United States Surgical, North Haven, CT, by letter dated May 5, 2004. Firm initiated recall is ongoing. PRODUCT: a) Auto Suture TA 30 Reloadable Staplers, Single Patient Use Ref TA30V3S, V3 (2.5mm) DST Series. Recall # Z-0958-04; b) Auto SutureTA 30 Reloadable Stapler, Single Patient Use, 3.5mm DST Series Ref: TA3035S. Recall # Z-0959-04; c) Auto SutureTA 30 Reloadable Stapler, Single Patient Use, 4.8mm DST Series Ref: TA30348S. Recall # Z-0960-04; d) Auto SutureTA 45 Reloadable Stapler, Single Patient Use, 3.5mm DST Series Ref: TA4535S. Recall # Z-0961-04; e) Auto SutureTA 45 Reloadable Stapler, Single Patient Use, 4.8mm DST Series Ref: TA4548S. Recall # Z-0962-04. f) Auto SutureTA 60 Reloadable Stapler, Single Patient Use, 3.5mm DST Series Ref: TA6035S. Recall # Z-0963-04; g) Auto SutureTA 60 Reloadable Stapler, Single Patient Use, 4.8mm DST Series Ref: TA6048S. Recall # Z-0964-04; h) Auto SutureTA 90 Reloadable Stapler, Single Patient Use, 3.5mm DST Series Ref: TA9035S. Recall # Z-0965-04; i) Auto SutureTA 90 Reloadable Stapler, Single Patient Use, 4.8mm DST Series Ref: TA9048S. Recall # Z-0966-04. REASON: Stapler may clamp without the staples being fired into the tissue. MANUFACTURER: Datex-Ohmeda, Inc., Madison, WI, by letters dated April 26, 2004. Firm initiated recall is ongoing. PRODUCT: a) Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used with a Model 7900 Ventilator, on a Aestiva/5 Anesthesia Machine. Recall # Z-0967-04; b) Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventilator, on a Aestiva/5 Anesthesia Machine. Recall # Z-0968-04; c) Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7900 Ventilator, on a Aestiva/5 Anesthesia Machine, in a Magnetic Reasonance Suite. Recall # Z-0969-04. REASON: Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System. MANUFACTURER: Medtronic Physio Control Corp., Redmond, WA, by letter on May 5, 2004. Firm initiated recall is ongoing. PRODUCT: DC Power Adapter for use with the LIFEPAK 12 defibrillator/monitor. Part numbers: VLP12-09-000031 through VLP12-09-000047. Recall # Z-0971-04. REASON: The DC Power Adapter may fail to charge LIFEPAK NiCd 2.4 AH batteries used with the LIFEPAK 12 defibrillator/monitor. MANUFACTURER: Diagnostic Products Corp., Los Angeles, CA, by e-mail or telephone on May 3, 2001. PRODUCT: Immulite 1000 CEA. Catalog No. LKCE1. Recall # Z-0972-04. REASON: Instability. Controls tend to run high of their target range. CLASS III MANUFACTURER: Staar Surgical Co., Inc., Monrovia, CA, by company representatives visits beginning on April 21, 2004. PRODUCT: MicroSTAAR Injector, MSI-PF Packed ten per box. Recall # Z-0957-04. REASON: Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 19, 2004: CLASS II MANUFACTURER: Electronic Technical Services, Ltd., Albuquerque, NM, by letter, beginning on April 28, 2004. Firm initiated recall is ongoing. PRODUCT: Microwave Ovens (modified for visually-impaired users). Recall # Z-0835/0840-04. a) Brand name Magic Chef, Models DM81K, MC-1004; b) Sharp, Models R-508AK, R-409AK; c) Emerson brand "Talking" ovens (modified by Electronic Technical Services); d) Goldstar, Models MA1012W and MA1112W; e) General Electric, Models JES1036WF and JES638WF; F) E-Wave, Model EW6F6W. REASON: The modified household microwave oven products failed to comply with the Federal Performance Standard for Microwave Ovens. MANUFACTURER: Boston Scientific Corp., Natick, MA, by letters dated March 29, 2004. Firm initiated recall is ongoing. PRODUCT: Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/Ref: PRTB10A, Model No. M001PRTB10A. Recall # Z-0847-04. REASON: Catheters may not have adequate radiopacity for proper visualization under fluoroscopy. MANUFACTURER: Arjo, Inc, Roselle, IL, by visit and Customer Advisory Notice dated January 30, 2003. Firm initiated recall is complete. PRODUCT: Minstrel Patient Lift; a non-AC-powered patient lift; Model Numbers HMB001-US and HMB002-US (with scale). Recall # Z-0883-04. REASON: The tension pin was not installed in spreader bar pivot bolt to prevent the pivot bolt from migrating out of the spreader bar, allowing the spreader bar to detach from the lift. MANUFACTURER: Kinetic Concepts, Inc., San Antonio, TX, by letter on March 22, 2004. Firm initiated recall is ongoing. PRODUCT: a) KCI TriaDyne Proventa Critical Care Therapy System, Model number 308900. Recall # Z-0887-04; b) KCI Therapulse II Air Suspension Therapy Bed, Model Number 227080. Recall # Z-0888-04; c) Burke Bariatric Bed, Model number 7064. Recall # Z-0889-04; d) KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, Model number 201189. Recall # Z-0890-04. REASON: Battery outgassing of powered hospital beds. MANUFACTURER: Ventlab Corp, Mocksville, NC, by letter on March 26, 2004. Firm initiated recall is ongoing. PRODUCT: a) STAT-Check, Adult Manual Emergency Resuscitator with A.C.E./STAT-Check CO_ Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC 9000 Series. Recall # Z-0891-04; b) STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO_ Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC-8000 Series, Recall # Z-0892-04; c) A.C.E. STAT-Check CO_ Indicator, Single, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order# SC200, Recall # Z-0893-04; d) STAT-Check Infant Disposable Manual Resuscitators, with 40 cmH_O Pressure Limiting System & Pressure Port Adapter, Single Patient Use Non-Sterile, Re-Order SC7000 Series, Non Latex. Recall # Z-0894-04; e) STAT-Check Infant Disposable Manual Resuscitators with Built-in Pressure Monitor, with 40 cmH_O Pressure Limiting System & Pressure Port Adapter, Single Patient Use, Non-Sterile, Re-Order SC7100 Series, Non Latex. Recall # Z-0895-04. REASON: In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure. MANUFACTURER: General Electric Med Systems, Waukesha, WI, by Field modification instructions on March 24, 2004. Firm initiated recall is ongoing. PRODUCT: a) Advantx 1 LC1, Model 46-279781P1, Angiographic X-ray System. Recall # Z-0896-04; b) Advantx 1 LC1, Model 45258230, Angiographic X-ray System. Recall # Z-0897-04; c) Advantx 1 LC2, Model 45562281, Angiographic X-ray System. Recall # Z-0898-04; d) Advantx 1 LC2, Model 2105657, Angiographic X-ray System. Recall # Z-0899-04; e) Advantx 1 SC, Model 36006617, Angiographic X-ray System. Recall # Z-0900-04. REASON: Unintended movements of both the C-arc and the image intensifier have occurred due to shearing of the gear motor shaft as a result of the misalignment of the gearbox. MANUFACTURER: Baxter Healthcare Renal Div., McGaw Park, IL, by letters dated April 12, 2004. Firm initiated recall is ongoing. PRODUCT: a) Baxter Renal Software Suite (Renal Link and PD Link). Recall # Z-0901-04; b) Renalsoft software system. Recall # Z-0902-04. REASON: There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications. MANUFACTURER: Respironics California Inc., Carlsbad, CA, by technician visit on or about June 1, 2001. Firm initiated recall is complete. PRODUCT: Esprit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics. Recall # Z-0903-04 REASON: Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue. MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letters on March 29, 2004. Firm initiated recall is ongoing. PRODUCT: UniCel Dxl 800 Access Immunoassay System, P/N 973100. Recall # Z-0904-04. REASON: Software coding error may cause a fatal error message. MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letters on March 31, 2004. Firm initiated recall is ongoing. PRODUCT: Coulter LH750 Hematology Analyzer. Part Number 6605632. Recall # Z-0905-04. REASON: If a customer enters a dilution factor for Sample B prior to the results from Sample A being transferred to the workstation, the predilute multiplication factor will be applied erroneously to the Sample A's results once they are received at the workstation. MANUFACTURER: Allergan Medical Optics, Inc., Santa Ana, CA, by letter on March 31, 2004. Firm initiated recall is ongoing. PRODUCT: Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40. Recall # Z-0907-04. REASON: The lots are being recalled because the tray lid may not be adequately sealed under the red arrow in the upper right corner of the package tray. The blue wrapping within the tray may not be sterile and may pose a potential risk of infection to the patient if used in a sterile field. MANUFACTURER: Wilson-Cook Medical Inc., Winston Salem, NC, by visit or fax on April 21, 2004. Firm initiated recall is ongoing. PRODUCT: Biliary Stent Introducer Set. Reorder (catalog) number SIS-10. Recall # Z-0908-04. REASON: The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter. MANUFACTURER: ADAC Laboratories, Madison, WI, by telephone and letters dated March 3, 2004. Firm initiated recall is ongoing. PRODUCT: a) Pinnacle3 Radiation Therapy Planning System, Model Number 9200-9052A-ENG. Recall # Z-0911-04; b) Pinnacle3 Radiation Therapy Planning System, Model Number 9200-0613C-ENG. Recall # Z-0912-04; c) Pinnacle3 Radiation Therapy Planning System, Part Number 9104-2011A Rev. A. Recall # Z-0913-04; d) Pinnacle3 Radiation Therapy Planning System, Part Number 9104-0121C Rev. A. Recall # Z-0914-04; e) Philips ADAC Pinnacle3 Radiation Therapy Planning Software Packaage (Kit), Model Number 9200-0613B-ENG. Recall # Z-0915-04; f) Philips Pinnacle3 Radiation Therapy Planning Software CD, Part Number 9104-0121B, Rev. A. Recall # Z-0916-04. REASON: A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong location may occur when using a Elekta Leksell headframe. MANUFACTURER: MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL, by letters dated April 26, 2004. Firm initiated recall is ongoing. PRODUCT: Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Model AED 10, part numbers 970300 (defibrillator) and 970302 (defibrillator with soft shell carrying case). Recall # Z-0918-04. REASON: A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED10 defibrillator. MANUFACTURER: BioMerieux, Inc., Hazelwood, MO, by letters dated April 20, 2004. Firm initiated recall is ongoing. PRODUCT: VITEK GPS-107 Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. Recall # Z-0919-04. REASON: Some of the cards were stamped with an incorrect card code causing system to read and report the cards incorrectly. MANUFACTURER: Alcon Research, Ltd., Fort Worth, TX, by service representative visit in May 2004. Firm initiated recall is ongoing. PRODUCT: Opthalmic Laser, product number 8065-5000-1. Recall # Z-0923-04. REASON: Product may generate laser light flashback. MANUFACTURER: Medtronic Gastroenterology/Urology, Shoreview, MN, by letters dated April 28, 2004. Firm initiated recall is ongoing. PRODUCT: Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081. Recall # Z-0924-04. REASON: Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short. MANUFACTURER: ACMI Corp., Southborough, MA, by letter dated April 30, 2004. Firm initiated recall is ongoing. PRODUCT: a) ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM. Recall # Z-0925-04; b) ACMI REF E-3F Electrohydraulic Lithotripsy Probe, 3 FR x 120CM. Recall # Z-0926-04; c) ACMI REF E-5F Electrohydraulic Lithotripsy Probe, 5 FR x 60CM. Recall # Z-0927-04; d) ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM. Recall # Z-0928-04. REASON: Product sterility may be compromised due to the lack of package seal integrity. MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on June 11, 2003. Firm initiated recall is complete. PRODUCT: Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid). Recall # Z-0935-04. REASON: Product was found to produce higher recoveries by about 7-12% compared to other lots. MANUFACTURER: Biotronik, Inc., Lake Oswego, OR, by letters on April 29, 2004. Firm initiated recall is ongoing. PRODUCT: a) Tachos DR - Implantable Cardioverter Defibrillator. Model Number 335 572. Recall # Z-0941-04; b) Tachos DR - Atrial Tx, Model Number 122 499. Recall # Z-0942-04; c) Tachos Atx, Model Number 334 342. Recall # Z-0943-04; d) Deikos A+, Model Number 3340341. Recall # Z-0944-04. REASON: Potential for device to not deliver full amount of energy. MANUFACTURER: Surgical Specialties Puerto Rico, Inc., Rincon, PR, by e-mail and fax from March 3, 2004 to April 1, 2004. Firm initiated recall is ongoing. PRODUCT: a) Stylus Angled Knife - 52-2835 Clear Corneal Knife, double bevel, parallel sides, angled, full handle, 2.85 Recall # Z-0945-04; b) Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and 56-5161, Pilot Tip Knife, bevel up, angled, full handled, 5.2mm. Recall # Z-0946-04; c) Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm 52-2761, Slit Knife, bevel up, angled, full handled, 2.75mm 52-2861, Slit Knife, bevel up, angled, full handled, 2.85mm 52-2961, Slit Knife, bevel up, angled, full handled, 3.0mm 52-3261, Slit Knife, bevel up, angled, full handled, 3.2mm 52-3561, Slit Knife, bevel up, angled, full handled, 3.5mm 52-2662, Slit Knife, bevel up, angled, blade and tip, 3.2mm 52-3262, Slit Knife, bevel up, angled, blade and tip, 3.2mm. Recall Z-0947-04; d) Stylus Brand Angled Knife - 52-2931, Slit Knife, double bevel, angled, full handle, 3.0mm 52-3231, Slit Knife, double bevel, angled, full handle, 3.2mm. Recall # Z-0948-04; e) Stylus Brand Angled Knife - 54-1010, Sharptome Crescent Knife, bevel up, angled, full handled. 54-1031, Sharptome Crescent Knife, double bevel, angled, full handled. Recall # Z-0949-04; f) Stylus Brand Angled Knives - 52-2912, Slit Knife, parallel sides, bevel up, angled, full handle, 3.0mm 52- 3212, Slit Knife, parallel sides, bevel up, angled, full handle, 3.2mm. Recall # Z-0950-04. REASON: Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker. MANUFACTURER: Medical Device Technologies, Inc., Gainesville, FL, by letter on March 2, 2004. Firm initiated recall is ongoing. PRODUCT: BioPince Full Core Biopsy Instrument packed in a Tyvek/plastic blister pack, which is labeled, as previously stated and also in a cardboard shelf carton. Recall # Z-0952-04. REASON: The outer plastic blister packaging material may be cracked thereby compromising the device's sterility barrier. CLASS III MANUFACTURER: Wilson-Cook Medical, Inc., Winston Salem, NC, by visit and letter on April 21, 2004. Firm initiated recall is ongoing. PRODUCT: AcuSnare" Polypectomy Device. The SASM device prefix denotes Soft AcuSnare Mini, Reorder (Catalog) number: SASM -1. The ASM device prefix denotes Acu Snare Mini, Reorder (Catalog) number: ASM-1. Due to the nitinol core wire, the difference between these two products is stiffness of the snare head wire. Recall # Z-0906-04. REASON: The snares inside the box labeled SASM-1 may actually be ASM-1 devices. The individual pouches may be correctly labeled ASM. MANUFACTURER: Spinal Concepts, Inc, Austin, TX, by letter on April 1, 2002. Firm initiated recall is complete. PRODUCT: a) 955-3 BacFix Coldwelder. Recall # Z-0920-04; b) 955-4 BacFix Coldwelder II with angled tip. Recall # Z-0921-04; c) 955-5 BacFix Coldwelder II with straight tip. Recall # Z-0922-04. REASON: The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site. MANUFACTURER: Medtronic Xomed, Inc., Jacksonville, FL, by letter on January 29, 2004. Firm initiated recall is complete. PRODUCT: a) Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83070. Recall # Z-0953-04; b) The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths. Recall # Z-0954-04; c) The product is a device used in adenoid surgery and is labeled as Lusk Disposable Adenoid Curettes. Recall # Z-0955-04. REASON: a) The curve in the shaft of the bur was only 15 degrees not the labeled 40 degrees; b) The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label; c) The box label indicated that the product is size 2 whereas a size 4 was packed inside. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 12, 2004: CLASS I MANUFACTURER: Medtronic MiniMed, Northridge, CA, by letters from March 2-5, 2004. Firm initiated recall is ongoing. PRODUCT: Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT-359L6 and MMT-359L9. (Differences in models is variation in length, 6 versus 9 MM.). Recall # Z-0910-04. REASON: Possibility of interrupted insulin flow. MANUFACTURER: BioMerieux Inc, by letters dated April 20, 2004. Firm initiated recall is ongoing. PRODUCT: VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. Recall # Z-0917-04. REASON: Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly. CLASS II MANUFACTURER: Krieger Medical, Inc., Woburn, MA, by letter on April 28, 2004. Firm initiated recall is ongoing. PRODUCT: Kreiger Tables, X-Ray tables for use with C-Arm X-Ray systems. Recall # Z-0819/0825-04. REASON: An incorrect identification label and the failure of certification testing program resulted in tables not complying with the U.S. Federal performance standard. MANUFACTURER: Hudson Respiratory Care Inc, Temecula, CA, by visit beginning on February 20, 2004. Firm initiated recall is ongoing. PRODUCT: Concho IV Plus Heated Humidifier. Recall # Z-0929-04. REASON: Software malfunctions. MANUFACTURER: American Medical Systems, Minnetonka, MN, by letters, dated April 29, 2004. Firm initiated recall is ongoing. PRODUCT: a) AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450. Recall # Z-0930-04; b) AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 16 cm, Diameter: 11 mm, Product Number 72401451. Recall # Z-0931-04. REASON: The product is mislabeled as to length. MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by phone on March 10, 2004. FDA initiated recall is complete. PRODUCT: a) AMPLICOR HPV Master Mix Analyte Specific Reagent HPV MMX), Catalog number 03582841190. Recall # Z-0933-04; b) AMPLICOR HPV Microwell Plate Analyte Specific Reagent MWP); catalog 03579229190. Recall # Z-0934-04. REASON: Marketed without PMA or 510(k) approval. MANUFACTURER: Medtronic Physio Control Corp, Redmond, WA, by letters on April 6, 2004. Firm initiated recall is ongoing. PRODUCT: LIFEPAK 12 defibrillator/monitor. Recall # Z-0938-04. REASON: Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator MANUFACTURER: Fischer Imaging Corporation, Denver, CO, by letter on April 19, 2004. Firm initiated recall is ongoing. PRODUCT: SenoScan True View Digital Mammography System. Recall # Z-0939-04. REASON: X-ray tube may overheat after high usage because of mis-wired thermal switch circuit. CLASS III MANUFACTURER: Surgical Specialties Corp, Reading, PA, by email on August 26, 2003. Firm initiated recall is complete. PRODUCT: Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles (double armed). Recall # Z-0936-04. REASON: Sterilization method incorrect. MANUFACTURER: Toshiba American Med Sys Inc, Tustin, CA, by letters and visits beginning on May 6, 2004. Firm initiated recall is ongoing. PRODUCT: Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems. Recall # Z-0937-04. REASON: Software anomaly. The region of the body was scanned, was different than programmed. MANUFACTURER: Kamiya Biomedical Company, Seattle, WA, by letters on March 30, 2004. Firm initiated recall is ongoing. PRODUCT: K-Assay Lp(a) Control. Recall # Z-0940-04. REASON: Assay result not consistent with the assigned control value. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 5, 2004: CLASS II MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letters dated May 28, 2003. Firm initiated recall is ongoing. PRODUCT: Axiom Artis System. Recall # Z-0848-04. REASON: Patient images misidentified. MANUFACTURER: USA Instruments, Inc., Aurora, OH, by letter on March 19, 2004. Firm initiated recall is ongoing. PRODUCT: Prima IIITotal SENSE Torso Coil (Body Array Coil), a Magnetic Imaging Accessory. This device is a component of the Magnetom TRIO 3.OT MRI Systems. Recall # Z-0849-04. REASON: A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's skin. MANUFACTURER: General Electric Med Systems, Waukesha, WI, by Field modification instructions on March 30, 2004. Firm initiated recall is ongoing. PRODUCT: a) GE Single 15 inches TV Monitor Suspension with Rail, Model 46-240485P1, Catalog number B0256EH. Recall # Z-0850-04; b) GE Single 15 inch TV Monitor Suspension for XT Bridge, Model 46-240485P2, Catalog Number B2056HA. Recall # Z-0851-04; c) GE Single 20 inch TV Monitor Suspension with Rail, Model 46-240485P5, Catalog Number B2056EC. Recall # Z-0852-04; d) GE Single 20-inch TV Monitor Suspension for XT Bridge, Model 46-240485P6, Catalog Number B2056EG. Recall # Z-0853-04. REASON: The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall. MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on March 2, 2004. Firm initiated recall is ongoing. PRODUCT: a) CryoValve Aortic Valve. Donor # 71893, Model #AV00. Recall # Z-0854-04; b) CryoValve Conduit and Pulmonary Valve and Conduit. Donor #71899, Model #PV00. Recall # Z-0855-04. REASON: A retrospective review of donor files conducted by CryoLife revealed an expired solution had been used during processing of the associated tissues. MANUFACTURER: Deltec, Inc., Saint Paul, MN, by letter dated March 26, 2004. Firm initiated recall is ongoing. PRODUCT: a) Port-A-Cath II Low Profile Epidural Implantable Access System, with PolyFlow Polyurethane Catheter, 1.2mm O.D. x 0.5mm I.D., REF 21-1501-01. Recall # Z-0856-04; b) Port-A-Cath II Epidural Low Profile Polysulfone/ Titanium Access System, with PolyFlow Polyurethane Catheter, 1.2mm O.D. x 5mm I.D., REF 21-1501-22. Recall # Z-0857-04; c) 6 Fr Introducer Set, REF 21-2320-24. Recall # Z-0858-04; d) 9 Fr Introducer Set, REF 21-2340-24. Recall # Z-0859-04; e) 8.5 Fr Introducer Set, REF 21-2370-24. Recall # Z-0860-04; f) Port-A-Cath Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4003-24. Recall # Z-0861-04; g) Port-A-Cath Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4009-24. Recall # Z-0862-04; h) Port-A-Cath Low Profile Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4035-24. Recall # Z-0863-04; i) Port-A-Cath Low Profile Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4037-24. Recall # Z-0864-04; j) Port-A-Cath II Polysulfone/Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4051-24. Recall # Z-0865-04; k) Port-A-Cath II Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-055-24. Recall Z-0866-04; l) Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4071-24. Recall Z-0867-04; m) Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4073-24. Recall # Z-0868-04; n) Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4083-24. Recall # Z-0869-04; o) Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4085-24. Recall # Z-0870-04; p) ProPort Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4155-24. Recall # Z-0871-04; q) ProPort Plastic Venous Access System, Pre-assembled wit PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4165-24. Recall # Z-0872-04; r) ProPort Low Profile Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4171-24. Recall # Z-0873-04; s) ProPort Low Profile Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 French Introducer Set, REF 21-4183-24. Recall # Z-0874-04; t) Port-A-Cath P.A.S. Port T2 Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 French Introducer Set, REF 21-4573-24. Recall # Z-0875-04; u) Port-A-Cath II Fluoro-Free Low Profile Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., and with CATH-FINDER Sensor Wire, REF 21-4685-24. Recall #Z-0876-04; v) Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with Dual-lumen PolyFlow Polyurethane Catheter, 2.2mm O.D. x 1.0mm I.D., 7 French Introducer Set, REF 21-8066-24. Recall # Z-0877-04; w) Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with Dual-lumen PolyFlow Polyurethane Catheter, 3.2mm O.D. x 1.4mm I.D., 10 French Introducer Set, REF 21-8068-24. Recall # Z-0878-04. REASON: Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. MANUFACTURER: Baxter Healthcare Corporation, Round Lake, IL., by letters dated April 13, 2004. Firm initiated recall is ongoing. PRODUCT: a) Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151 and 2M8151K (United Kingdom); Made in Singapore; monochrome display screen. Recall # Z-0879-04; b) Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153K (United Kingdom); Made in Singapore; monochrome display screen. Recall # Z-0880-04; c) Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161; Made in Singapore; color display screen. Recall # Z-0881-04; d) Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163; Made in Singapore; color display screen. Recall # Z-0882-04. REASON: Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time. MANUFACTURER: Medtronic Physio Control Corp, Redmond, WA, by telephone on April 2, 2004. Firm initiated recall is ongoing. PRODUCT: LIFEPAK 500 automated external defibrillator. Part numbers 3005380-000 through 3005380-006 and 3005380-014. Recall # Z-0886-04. REASON: Potential for batteries to malfunction due to battery cell rupture. CLASS III MANUFACTURER: DWL Systems, Inc., Sterling, VA, by letter on January 5, 2004. Firm initiated recall is ongoing. PRODUCT: EZ-DOP, diagnostic ultrasound imaging system. Recall # Z-0885-04. REASON: A certain sequence of data entries on the keypad could cause the ultrasound medical device to display incorrect transmission power. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 28, 2004: CLASS I MANUFACTURER: Medtronic Inc., Cardiac Rhythm Management, Fridley, MN, by letter on April 5, 2004. Firm initiated recall is ongoing. PRODUCT: a) Medtronic Micro Jewel II Implantable Cardioverter Defibrillators, Model 7223Cx. Recall # Z-0811-04; b) Medtronic GEM DR Implantable Cardioverter Defibrillators, Model 7271. Recall # Z-0812-04. REASON: Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected charge circuit time-outs or charge circuit inactive conditions as the battery voltage nears the level for Elective Replacement of the devices. CLASS II MANUFACTURER: Coherent, Inc., Santa Clara, CA, by representative visit on or before April 2, 2004. Firm initiated recall is complete. PRODUCT: DUO Laser System, Class IV laser diode material processing machine. Recall # Z-0540-04. REASON: Unintended emission of laser radiation. MANUFACTURER: Nova Biomedical Corporation, Waltham, MA, by telephone and letter on March 31, 2004. Firm initiated recall is ongoing. PRODUCT: a) Stat Profile Critical Care Xpress (CCX) Analyzer. Catalog
Number: 35942. Recall # Z-0826-04; b) Stat Profile Critical Care Xpress
CCX+ Analyzer. Catalog Number: 37413. Recall # Z-0827-04; c) Stat Profile
Critical Care Xpress CCX (R) Analyzer. Catalog Number: 37562
R=Refurbished. Recall # Z-0828-04; d) Stat Profile Critical Care Xpress
CCX+(R) Analyzer. Catalog Number: 37555 R=Refurbished. REASON: Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems. MANUFACTURER: Hu-Friedy Mfg., Co., Inc., Chicago, IL, by telephone on March 29, 2004, and by letter on April 2, and April 5, 2004. Firm initiated recall is ongoing. PRODUCT: a) Henry Schein (r) Product Code/Mfr. Part Code 101-0913 Explorer #2 D/E. Made in China. For professional use Only. Instruments must be cleaned and sterilized prior to use. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k) exempt, Class I device, Device Listing #B057701. Recall # Z-0832-04;b) Henry Schein (r) Product Code/Mfr. Part Code 100-3620 Explorer-Single End #23 SE. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k) exempt, Class I device, Device Listing #B057701. Recall # Z-0833-04; c) Henry Schein (r) Product Code/Mfr. Part Code 100-8008 Explorer-Double End #5. Made in China. For professional Use only. Instruments must be cleaned and sterilized prior to use. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k) exempt, Class I device, Device Listing #B057701. Recall # Z-0834-04; REASON: The tips of the instruments may have been improperly heat-treated and have the potential for unexpected tip fracture. MANUFACTURER: Gyrus Medical, Inc., Maple Grove, MN, by letter on December 5, 2003. Firm initiated recall is ongoing. PRODUCT: Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications. Recall # Z-0841-04. REASON: The generator may malfunction when used in close proximity to a monopolar generator. MANUFACTURER: Boston Scientific Corp., Glens Falls, NY, by letter dated April 2, 2004 flagged as an addendum to a letter dated March 18, 2004. Firm initiated recall is ongoing. PRODUCT: Boston Scientific MEDI-TECH***VASCULAR DILATOR***Order No./REF: 48-151 M001481510, 5 Fr. Product in clear plastic pouch. Recall # Z-0842-04. REASON: Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr. MANUFACTURER: Busse Hospital Disposables, Hauppauge, NY, by letters on April 13, 2004. Firm initiated recall is ongoing. PRODUCT: a) Suction Instrument with Tubing, Catalog No. 302. Instrument: Yankauer without Vent. *Tubing: 6" x 1/4" I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. Packaged and Sterilized in the U.S.A. *Tubing Made in Mexico. Classification Name: Unit, Suction Operatory. Class I device, 510(k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton. Recall # Z-0843-04; b) Suction Instrument with Tubing, Catalog No. 303. Instrument: Yankauer with Vent. *Tubing: 6" x 1/4" I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. *Tubing Made in Mexico. Classification Name: Unit, Suction Operatory. Class I device, 510 (k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Type(R) and plastic film. There are 20 units per shipping carton. Recall # Z-0844-04; c) Suction Instrument with Tubing, Catalog No. 305. Instrument: Yankauer without Vent. *Tubing: 10" x 1/4" I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. Classification Name: Unit, Suction Operatory. Class I device, 510 (k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Type(R) and plastic film. There are 20 units per shipping carton. Recall # Z-0845-04. REASON: Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a slower rate of suction. CLASS III MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on March 23, 2004. Firm initiated recall is ongoing. PRODUCT: ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT C8000 Processing Module. Recall # Z-0818-04. REASON: When using a LIS the software system will send up a test result of up to 20 characters although the field is set to display only 15 characters per the RS-232 Manual. MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on March 22, 2004. Firm initiated recall is ongoing. PRODUCT: AEROSET Analyzer System, Model 9D05-01. Recall # Z-0846-04. REASON: Change of level 3 error log messages to level 1 to prevent suspect assay results. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 21, 2004: CLASS II MANUFACTURER: Becton Dickinson Infusion Therapy, Sandy, UT, by telephone and letter on March 9, 2004. Firm initiated recall is ongoing. PRODUCT: a) BD L-Cath NN (24ga x 30cm), L-Cath Catheter System. Recall # Z-0783-04; b) BD L-Cath EX (20ga x 15cm), L-Cath Catheter System. Recall # Z-0784-04; c) BD L-Cath EX (28ga x 20cm), L-Cath Catheter System. Recall # Z-0785-04. REASON: Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion. MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on March 8, 2004. Firm initiated recall is ongoing. PRODUCT: a) Philips MX8000 IDT CT Scanner System, 10 & 16 slice images. Recall # Z-0786-04; b) Philips Brilliance CT Scanner System, 6, 10 & 16 slice images. Recall # Z-0787-04. REASON: The CT couch may move downward to its lower limit without command. MANUFACTURER: Spencer Technologies, Inc., Seattle, WA, by letter dated February 17, 2004. Firm initiated recall is ongoing. PRODUCT: Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial Doppler Ultrasound System (these systems are the same hardware and software - the change from TCD 100M to PMD 100 is a marketing change). Software version 1.3.0 Model numbers 10119, 10863, 10919, 10968, 11016, 11052, 11090, 11091, 11235, 11236. Recall # Z-0788-04. REASON: Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis. MANUFACTURER: Bemis Manufacturing Co., Sheboygan Falls, WI, by letters dated February 25, 2004. Firm initiated recall is ongoing. PRODUCT: Bemis Two-Gallon Sharps Container, Models #102 020, #102 030, and #102 040. (The only difference between the models is in color. Model 102 040 is yellow, Model 102 020 is beige and Model 102 030 is red.). Recall # Z-0789-04. REASON: The closure flap of the recalled sharps containers have two tabs that fit into slots on the cover for final closure and locking but some of the covers have one of the tabs that will not fit into the designated slot because the slot is occluded with plastic. MANUFACTURER: Guidant Corp-Cpi Division, Saint Paul, MN, by visit starting on March 11, 2003. Firm initiated the recall is ongoing. PRODUCT: a) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter
.087", 2.21 mm, Overall Length 54 cm, CS Wide Tip Shape, CS-W, REF 6705.
Recall # Z-0790-04; b) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 44 cm, Coronary Sinus -
Multi-Purpose Tip Shape, CS-MP, REF 6716. Recall # Z-0791-04; c) Guidant
EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21 mm, Overall
Length 49 cm, Coronary Sinus - Multi-Purpose Tip Shape, CS-MP, REF 6717.
Recall Z-0792-04; d) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 49 cm, Coronary Sinus -
Multi-Purpose Hook Tip Shape, CS-MPH, REF 6752. Recall # Z-0793-04. e)
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21 mm,
Overall Length 49 cm, Coronary Sinus - Hook Tip Shape, CS-H, REF 6754.
Recall Z-0794-04; f) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 49 cm, Coronary Sinus -
Multi-Purpose Long Tip Shape, CS-MPL, REF 6756. Recall Z-0795-04; g)
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21 mm,
Overall Length 49 cm, Coronary Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF
6758. Recall # Z-0796-04; h) Guidant Rapido 8 French Guiding Catheter,
Inner Diameter .087", 2.21 mm, Overall Length 54 cm, Coronary Sinus -
Extended Hook Tip Shape, CS-Extended H, REF 6778. Recall # Z-0797-04; i)
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21 mm,
Overall Length 54 cm, Coronary Sinus - Multi-Purpose Tip Shape, CS-MP, REF
7300. Recall # Z-0798-04; REASON: The terminal hub component in some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement. MANUFACTURER: Spinal Concepts, Inc., Austin, TX, by telephone on March 1, 2004 and by letter on March 5, 2004. Firm initiated recall is ongoing. PRODUCT: a) One-level Ant-Cer Plates (Assembly Level). 1706-1024, 1706-1026, 1706-1028, 1706-1030, 1706-1032, and product literature. Recall # Z-0807-04; b) 1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Recall #Z-0808-04. REASON: Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo. MANUFACTURER: Centerpulse Orthopedics, Inc., Austin, TX, by telephone and letters on September 30, 2003 and by letter on March 8, 2004. Firm initiated recall is ongoing. PRODUCT: RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes. Recall # Z-0809-04. REASON: Complaints of acetabular shell disassociating with the bone. MANUFACTURER: Hill-Rom Manufacturing, Inc, Charleston, SC, by letter on March 9, 2004. Firm initiated recall is ongoing. PRODUCT: Magnum II Bariatric Patient Care System. REASON: Bed may pose a health hazard due to: a) Inability to articulate the frame during transport; b) Exposed sharp edge of footplate; c) Shear point between seat section and lymph panel and d) Patient fall. MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by telephone on January 30, 2004. Firm initiated recall is complete. PRODUCT: CryoValve, Pulmonary Valve and Conduit. Model # PV00. Donor #69347. Recall # Z-0814-04. REASON: CryoLife was notified by the Tennessee Department of Health, that a recipient had contracted a Group A Streptococcus infection from orthopedic tissue originating from the same donor as CryoLife donor 69347. MANUFACTURER: Bacchus Vascular, Inc., Santa Clara, CA, by telephone and/or visit on November 24, 2003. Firm initiated recall is ongoing. PRODUCT: a) Bacchus brand Trellis(tm) Plus, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRR 006 140 10, BAC TRR 006 140 20. Recall # Z-0816-04; b) Bacchus brand Trellis(tm) Reserve, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRE 06 100 10, BAC TRE 06 100 20, BAC TRE 06 140 10, BAC TRE 06 140 20. Recall # Z-0817-04. REASON: The device has the potential for fractures at the distal end during use. CLASS III MANUFACTURER: Medex, Inc., Duluth, GA, by letter starting on February 2, 2004. Firm initiated recall is ongoing. PRODUCT: Medex 3000 Series Syringe Infusion Pumps. REASON: Inadequate warning label: It is possible for an Extracorporeal Membrane Oxygenation (ECMO) circuit to generate high negative pressures on the inlet side. MANUFACTURER: Medtronic Perfusion Systems, Brooklyn Park, MN, by letter on March 25, 2004. Firm initiated recall is ongoing. PRODUCT: Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R. Recall # Z-0815-04. REASON: An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 14, 2004: CLASS II MANUFACTURER: Becton Dickinson & Company, Franklin Lakes, NJ, by letters dated January 29, 2004. Firm initiated recall is ongoing. PRODUCT: a) BD Test Strips. The US market BD Test Strips are identified by Catalog Numbers 322027 (50 count BD Test Strips Durable medical Equipment consignees), 322053 (50 Count BD Test Strips Trade consignees), and 322060 (10 Count BD Test Strips packaged within BGM kits). The Canadian market BD Test Strips are identified by Catalog Numbers 322002 (50 count BD Test Strips), 322003 (100 count BD Test strips), and 322009 (10 count BD Teststrips). Health Hazard Evaluation: There is negligible medical risk to patients with diabetes using the BD blood glucose systems due to the increase of E-3 error messages. Recall # Z-0763-04; b) The BD Blood Glucose Monitoring Systems identified as the BD Latitude, and BD Logic. Becton Dickinson also distributes the Paradigm Link Blood glucose Monitor which is sold exclusively for Medtronic Mini Med. US Market BD Blood Glucose Monitoring System kit catalog Numbers: 322025 (BD Logic Blood Glucose Monitor Durable Medical Equipment consignees); 322050 (BD Latitude Diabetes Management System); 322051 (BD Logic Blood Glucose Monitor); 32205175 ( BD Logic Blood Glucose Monitor); 322200 (Paradigm Link Blood Glucose Monitor - clear); 322201 ( Paradigm Link Blood Glucose Monitor - smoke); 322202 (Paradigm Link Blood Glucose Monitor - blue); 322203 (Paradigm Link Blood Glucose Monitor - purple). Canadian market BD Blood Glucose Monitoring System kit catalog numbers: 322000 (BD Latitude Diabetes Management System); 322001 (BD Logic Blood Glucose Monitor). Recall # Z-0764-04. REASON: 39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing. MANUFACTURER: Steris Corp., Mentor, OH, by letter and in person beginning on March 18, 2004. Firm initiated recall is ongoing. PRODUCT: QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel
GI Endoscopes, in the Steris System 1 Sterile Processing System with the
C1160 Universal Flexible Processing Tray, Cat. No. QPT1680. REASON: A defective port adapter may affect the sterilization process of the attached endoscope. MANUFACTURER: Zimmer, Inc., Warsaw, IN, by e-mail on March 16, 2004. Firm initiated recall is ongoing. PRODUCT: a) Zimmer brand Coonrad/Morrey total elbow interchangeable
ulnar assembly, small, left, 3 in. length, tivanium TI-6AL-4V alloy/UHMWPE,
sterile, for use with bone cement. Cat. No. 32-8105-53-01. REASON: Right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants. MANUFACTURER: Abbott Laboratories Diagnostic, Div., South Pasadena, CA, by letters on March 18, 2004. Firm initiated recall is ongoing PRODUCT: Clinical Chemistry Uric Acid; LN 7D76-20. REASON: Unacceptable upward drift of results in control runs within 24 hour period. MANUFACTURER: Genzyme Diagnostics, San Diego, CA, by letters on March 2004. Firm initiated recall is ongoing. PRODUCT: Giardia/Cryptosporidium Rapid In-vitro diagnostic Test Kits. These are sold under two names as follows: Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac Giardia/Cryptosporidium Rapid Assay. Recall # Z-0770-04. REASON: False Positive results. MANUFACTURER: Codman & Shurtleff, Inc., Raynham, MA, by telephone on March 11, 2004. Firm initiated recall is complete. PRODUCT: Codman Holter Salmon Rickham Reservoir with Ventricular
Catheter, Catalog Number: 82-1671. REASON: Drainage tips absent from catheter tip. MANUFACTURER: Cryolife, Inc, Kennesaw, GA, by telephone on February 20, 2004 and by letter on April 2, 2004. Firm initiated recall is ongoing PRODUCT: Cryo Valve, Aortic Valve & Conduit. Donor #69588, Model #AVOO. Recall # Z-0776-04. REASON: Microorganisms were detected in donor tissue associated with this allograft, specifically Aeormonas hydrophila. MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated February 23, 2004. Firm initiated recall is complete. PRODUCT: Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156. Recall # Z-0777-04. REASON: The locking ring was not included and the shoulder implanted without the locking ring. MANUFACTURER: Binax, Inc, Portland, OR, by telephone, e-mail and letter on February 18, 2004. Firm initiated recall is complete. PRODUCT: a) NOW RSV Test. Item Number 430-430, Kit Number 430-00R. Recall # Z-0778-04;b) NOW Filariasis Rapid test for W. bancrofti antigen.(Export use only) Item Number 620-430, Kit Number 620-000. Recall # Z-0779-04;c) NOW Malaria (Export use only) Item Number 660-430, Kit Number 66005, Kit Number 660-000. Recall # Z-0780-04. REASON: Pouch integrity compromised. MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by e-mail on March 23, 2004. Firm initiated recall is ongoing. PRODUCT: Architect Ca 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests). Recall # Z-0781-04. REASON: The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents. MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by telephone on March 26, 2004 and by letter dated March 25, 2004. Firm initiated recall is ongoing. PRODUCT: AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit. Recall # Z-0782-04. REASON: An increase in complaints of higher than normal patient results, some from the healthy population range to above the diagnostic cutoff for an Acute Myocardial Infarction. CLASS III PRODUCT: MicroSTAAR Injector w/Foam Tip Plunger, Model MSI-PF. Recall # Z-0766-04. REASON: Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use. MANUFACTURER: Biomerieux, Inc., Durham, NC, by letter on September 29, 2003. Firm initiated recall is ongoing. PRODUCT: Coag-A-Mate( MTX and MTX II Instrument Operator Manual. Recall # Z-0771-04. REASON: Typographical error in the Operator Manual. In Chapter 11 of the MTX/MTX II Operator Manual, the numerical range for the Warning Flag is shown as 00-99. The correct numerical range is 0-99. The "list of error and warning" chart shows a numerical range representing the codes 00-9. The correct numerical range for the first ten error/warning codes are 0-9. MANUFACTURER: Dade Behring, Inc., Newark, NJ, by letters dated March 4, 2004. Firm initiated recall is ongoing. PRODUCT: Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials. Recall # Z-0773-04. REASON: Cloudy appearance or precipitate. MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on March 24, 2004. Firm initiated recall is ongoing. PRODUCT: a) Cryo Valve, Pulmonary Valve & Conduit. Donor # 69091, Model
# PVOO. Recall # Z-0774-04;b) Cryo Valve, Aortic Valve & Conduit. Donor #
69091, REASON: The donor of the tissue had a viral syndrome at the time of death. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 7, 2004: CLASS II MANUFACTURER: Weber Marking System, Inc., Arlington Heights, IL, by letter dated September 12, 2003. Firm initiated recall is ongoing. PRODUCT: Weber SolarJet S CO2 Vector Laser Coder System. REASON: The laser product failed to comply with the performance standards, including certification, identification, warning logotype label, aperture label and submission of a product report. MANUFACTURER: Carbomedics, Inc., Austin, TX, by letters in mid-May 2002. Firm initiated recall is complete. PRODUCT: Carbomedics VT-200 Valve Tester. Recall # Z-0738-04. REASON: Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use. MANUFACTURER: Asahi Medical Co., Ltd, Chiyoda Ku, JP, by visit starting on October 1, 2001. Firm initiated recall is complete PRODUCT: Asahi APS Series Dialyzers, Model Nos. APS-100S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S. The dialyzers are intended for single or initial use and under reprocessing and reuse conditions for up to 15 reuse cycles. Recall # Z-0739-04. REASON: Customer reprocessing methods for the reusable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis. MANUFACTURER: Welch Allyn, Inc, Skaneateles Falls, NY, by letters dated March 1, 2004. FDA initiated recall is ongoing. PRODUCT: a) NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a
disposable 1 piece cuff for single patient use only. Sold under the Welch
Allyn label with Part #5082-101-1, and sold as part of a multi-pack (1 of
each size) with Part #5082-241-9; Allegiance "Tactics" label with Part
#30502-110S; and Arden label with Part #5084-101-1. Recall # Z-0748-04;b)
NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1
piece cuff, for single patient use only. Sold under the Welch Allyn "Tycos"
label with Part #s 5082-101-2, 5082-101-2CL, and sold as part of a
multi-pack (1 of each size) with Part #5082-241-10; Allegiance "Tactics"
label with Part #s 30502-110 and 30502-210; and Arden label with Part #s
5084-101-2 and 633-5084-101-2. Recall # Z-0749-04;c) NEONATE 2 DISPOSABLE
BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single
patient use only. Sold under the Welch Allyn "Tycos" label with Part #
5082-102-1 and sold as part of a multi-pack (1 of each size) with Part
#5082-241-9; Allegiance Healthcare "Tactics" label with Part # 30502-111S;
and Arden label with Part # 5084-102-1. Recall # Z-0750-04;d) NEONATE 2
DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for
single patient use only. Sold under the Welch Allyn "Tycos" label with
Part #5082-102-2, 5082-102-2CL, 671-5082-102-2, and sold as part of a
multi-pack (1 of each size) with Part #5082-241-10; Allegiance Healthcare
"Tactics" label with Part # 30502-111 and 30502-211; and Arden label with
Part # 5084-102-2 and 634-5084-102-2. Recall # Z-0751-04; REASON: GMP deficiencies. MANUFACTURER: Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letters dated March 11, 2004. Firm initiated recall is ongoing. PRODUCT: Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R. Recall # Z-0758-04. REASON: Microbubbles of air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian. MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated March 15, 2004. Firm initiated recall is ongoing PRODUCT: Hill-Rom brand TotalCare bed system; model P1900 - remanufactured only. Recall # Z-0761-04. REASON: A warning label, advising users not to use oxygen tents with this equipment because of the potential for a fire, was not placed on these remanufactured beds. CLASS III MANUFACTURER: Boston Scientific Corporation, Natick, MA, by letter dated March 5, 2004. Firm initiated recall is ongoing. PRODUCT: a) VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-988. Recall # Z-0759-04;b) VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (5 Fr), a 21 Ga. Echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-994. Recall # Z-0760-04. REASON: Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 31, 2004 MANUFACTURER: BioMerieux, Inc., Hazelwood, MO, by letters dated January 28, 2004 and March 9, 2004. Firm initiated recall is ongoing. PRODUCT: VITEK GPS-107Gram Positive Susceptibility Card, Catalog # V4368, for in-vitro diagnostic use, 20 cards per package. Recall # Z-0721-04. REASON: Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly. CLASS II MANUFACTURER: BioMerieux, Inc, Hazelwood, MO, by letters dated January 15, 2004, and March 9, 2004. Firm initiated recall is ongoing. PRODUCT: VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. Recall # Z-0725-04. REASON: The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly. MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated March 8, 2004. Firm initiated recall is ongoing. PRODUCT: Hill Rom brand Advanta bed; model P1600. Recall # Z-0726-04. REASON: A potential pinch/shear point exists between the restraint strap hook located underneath the knee section and the foot rail mounting of the bed. MANUFACTURER: General Electric Medical Systems Information Technology, Milwaukee, WI, by letter on February 27, 2004. Firm initiated recall is ongoing. PRODUCT: PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx. Recall # Z-0727-04. REASON: Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly. MANUFACTURER: Boston Scientific Scimed, Maple Grove, MN, by letter dated February 13, 2004. Firm initiated recall is ongoing. PRODUCT: Impulse Single 5F 145 Multipack Catheters, Catalog Number H749163913011. Recall # Z-0729-04. REASON: Some of the catheters may have yellow foreign material in their pigtail tips. The foreign material in the device could cause a stroke or significant damage to organs other than the brain. MANUFACTURER: Gish Biomedical, Inc., Rancho Santa Margarita, CA, by letters on March 4, 2004. Firm initiated recall is ongoing. PRODUCT: Vision Hollow Fiber Oxygenator with GBS Coating. Recall # Z-0730-04. REASON: Customers reported leakage. MANUFACTURER: Boston Scientific Corporation, Natick, MA, by letters dated February 9, 2004. Firm initiated recall is ongoing. PRODUCT: a) Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Mini Titanium port, Implantable Port System, Model # M001452150, Catalog #45-215. Recall # Z-0731-04; b) Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD Titanium Port, Implantable Port System, Model # M001453620, Catalog #45-362. Recall # Z-0732-04; c) Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Low Profile PS port, Implantable Port System, Model # M001452380, Catalog #45-238. Recall # Z-0733-04; d) Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD PS port, Implantable Port System, Model # M001453660, Catalog #45-366. Recall # Z-0734-04. REASON: Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter. MANUFACTURER: Biomerieux, Inc, Durham, NC, by service representative beginning on February 26, 2004. Firm initiated recall is complete. PRODUCT: NucliSensâ Easy Q Incubator, Product Number 285204 (this number can be found at the back of the instrument. Recall # Z-0735-04. REASON: Instrument malfunction. Electrical short circuit may occur resulting in damage or a fire hazard. MANUFACTURER: Instrumentation Laboratory Co, Lexington, MA, by letter on March 9, 2004. Firm initiated recall is ongoing. PRODUCT: a) ACL Futura Instrument Analyzer. Recall # Z-0736-04; b) ACL Advance Instrument Analyzer. Recall # Z-0737-04. REASON: Software may cause instrument to omit step causing reagent carryover, which may effect patient test result. MANUFACTURER: Cryolife Inc, Kennesaw, GA, by telephone on February 18, 2004. Firm initiated recall is complete. PRODUCT: a) CryoValve, Aortic Valve and Conduit. Recall # Z-0746-04; b) CryoValve, Pulmonary Valve and Conduit. Recall # Z-0747-04. REASON: CryoLife received additional information after release of tissue indicating the donor had repeatedly reactive test results for antibody to HCV (EIA) in 1995. CLASS III MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter dated February 16, 2004. Firm initiated recall is ongoing. PRODUCT: TDx/TDxFLx Cortisol Reagent Pack, list 9116-65. Recall # Z-0723-04. REASON: The package inserts contain incorrect control values for the urinary free cortisol extraction procedure. MANUFACTURER: Diagnostic Products Corp, Los Angeles, CA, by letter on February 23, 2004. Firm initiated recall is ongoing. PRODUCT: IMMULITE 2000 Intact PTH kit. Recall # Z-0724-04. REASON: High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA. MANUFACTURER: Ciba Vision Corporation, Duluth, GA, by letter on March 11, 2004. Firm initiated recall is ongoing. PRODUCT: a) FreshLook ColorBlends®, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH -5.25, LOT ***, 2006-08. Product is packed in 6 packs. Recall # Z-0740-04; b) FreshLook® Colors, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH ***, LOT ***, 2006-11, 6-pack, 2 pack and single trial. Product is packed in 6 packs, 2 packs and single trial packs (Samples not for sale). Recall # Z-0741-04; c) FreshLook® Enhancers, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Sterile, SPH-0.75, LOT ***, 2008-06, WJ®, Product is packed in 6 packs. Recall # Z-0742-04. d) FreshLook® Toric, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Sterile, SPH -1.50, CYL-0.75, AXIS 020, LOT ***, 2006-04, Product is packed in 6 packs. Recall # Z-0743-04. REASON: The lens inside the package does not match the prescription information labeled on the primary package. MANUFACTURER: Siemans Medial Solutions USA, Inc, Plymouth Meeting, PA, by telephone from February 22/16, 2004. Firm initiated recall in ongoing. PRODUCT: Acuson Cypress Echocardiography System. Catalog number 8264604; Recall # Z-0744-04. REASON: Software problem - mode does not appear on screen. MANUFACTURER: Rad-Source Technologies, Inc., Boca Raton, FL, by e-mail on May 9, 2002. Firm initiated recall is complete. PRODUCT: RAD SOURCE RS 3000 Blood Irradiator Three Bag Option. Recall # Z-0745-04. REASON: The firm completed a cooling system retrofit to preclude overheating and failure. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 24, 2004 CLASS I MANUFACTURER: Moving Solutions, Inc., Downers Grove, IL, by letters on November 29, 2001, January 24, 2004 and March 11, 2004. FDA initiated recall is ongoing. PRODUCT: a) Faaborg patient lift/hoist, battery operated lifts. The PL series lifts have electric parallel base widening, with a weight capacity of 365 lbs. to 550 lbs. depending on the base model. The Users Guide refers to the lift as a "Faaborghoist". Recall # Z-0551-04; b) Faaborg patient lift/hoist, battery operated lifts. The VL series lifts have electric V-shape base widening, with a weight capacity of 365 lbs. to 550 lbs. depending on the base model. Recall # Z-0552-04; c) Faaborg patient lift/hoist, battery operated lifts. The Solution/Nordic series lifts have electric V-shape base widening, with a weight capacity of 210 lbs. to 365 lbs. depending on the base model. Recall # Z-0553-04 REASON: Excessive wear of the hanger bar bolt, that connects the lift arm to the sling spreader bar, may cause the bolt to snap allowing the patient to fall. CLASS II MANUFACTURER: Coherent, Inc., Santa Clara, CA., by service representative visit beginning on January 21, 2004. Firm initiated recall is ongoing. PRODUCT: Laser system, DUO System, Class IV laser diode material processing machine. Recall # Z-0360-04. REASON: Unintended emission of laser radiation. MANUFACTURER: Lodox Systems, South Lyon, Mi, by service technician visit beginning on March 16, 2004. Firm initiated recall is ongoing. PRODUCT: Statscan digital radiographic system for Diagnostic Radiography. Recall # Z-0389-04. REASON: The units are defective under 21 CFR 1010.2 in that the identification and certification labels were inadequate or missing. In addition there was inadequate testing and quality control procedures to establish certification. This can result in misleading the purchasers and manufacturers about requirements for certification of products introduced into commerce. The required tracking for components may not be followed and thus a loss of traceability. MANUFACTURER: Coherent Inc Laser Group, Santa Clara, CA, by letter and on-site visit on November 7, 2003. Firm initiated recall is ongoing. PRODUCT: Coherent brand Quattro Diode Laser Systems; A Quattro FAP System. Recall # Z-0357-04. REASON: Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated. MANUFACTURER: Ev3, Inc., Saint Paul, MN, by letter on January 30, 2004. Firm initiated recall is ongoing. PRODUCT: a) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm x 21mm 80 cm .018" REF PMB 8-7-21-80. Recall # Z-0597-04; b) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm x 18mm 80 cm .018" REF PMB 8-7-18-80. Recall # Z-0598-04; c) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm x 14mm 80 cm .018" REF PMB 8-7-14-80. Recall # Z-0599-04; d) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 21mm 80 cm .018" REF PMB 8-6-21-80. Recall # Z-0600-04; e) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 18mm 80 cm .018" REF PMB 8-6-18-80. Recall # Z-0601-04; f) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 14mm 80 cm .018" REF PMB 8-6-14-80. Recall # Z-0602-04; g) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm x 21mm 80 cm .018" REF PMB 8-5-21-80. Recall # Z-0603-04; h) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm x 18mm 80 cm .018" REF PMB 8-5-18-80. Recall # Z-0604-04; i) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm x 14mm 80 cm .018" REF PMB 8-5-14-80. Recall # Z-0605-04; j) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm x 21mm 80 cm .014" REF PMB 4-7-21-80. Recall # Z-0606-04; k) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm x 18mm 80 cm .014" REF PMB 4-7-18-80. Recall # Z-0607-04; l) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm x 14mm 80 cm .014" REF PMB 4-7-14-80. Recall # Z-0608-04; m) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 21mm 80 cm .014" REF PMB 4-6-21-80. Recall # Z-0609-04; n) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 18mm 80 cm .014" REF PMB 4-6-18-80. Recall # Z-0610-04; o) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 14mm 80 cm .014" REF PMB 4-6-14-80. Recall # Z-0611-04; p) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm x 21mm 80 cm .014" REF PMB 4-5-21-80. Recall # Z-0612-04; q) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm x 18mm 80 cm .014" REF PMB 4-5-18-80. Recall # Z-0613-04; r) ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm x 14mm 80 cm .014" REF PMB 4-5-14-80. Recall # Z-0614-04; s) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 7mm x 21mm 80 cm .018" REF PMP 8-7-21-80. Recall # Z-615-04; t) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 7mm x 18mm 80 cm .018" REF PMP 8-7-18-80. Recall # Z-616-04; u) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 7mm x 14mm 80 cm .018" REF PMP 8-7-14-80. Recall # Z-617-04; v) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 6mm x 21mm 80 cm .018" REF PMP 8-6-21-80. Recall # Z-618-04; w) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 6mm x 18mm 80 cm .018" REF PMP 8-6-18-80. Recall # Z-619-04; x) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 6mm x 14mm 80 cm .018" REF PMP 8-6-14-80. Recall # Z-620-04; y) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 5mm x 21mm 80 cm .018" REF PMP 8-5-21-80. Recall # Z-621-04; z) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 5mm x 18mm 80 cm .018" REF PMP 8-5-18-80. Recall # Z-622-04; aa) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 5mm x 14mm 80 cm .018" REF PMP 8-5-14-80. Recall # Z-623-04; bb) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 7mm x 21mm 80 cm .014" REF PMP 4-7-21-80. Recall # Z-624-04; cc) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 7mm x 18mm 80 cm .014" REF PMP 4-7-18-80. Recall # Z-625-04; dd) ParaMount Mini GPS Stent System, PeripheralSystem, Balloon Expandable Stent and Delivery System, 7mm x 14mm 80 cm .014" REF PMP 4-7-14-80. Recall # Z-626-04; ee) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 6mm x 21mm 80 cm .014 REF PMP 4-6-21-80. Recall # Z-627-04; ff) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 6mm x 18mm 80 cm .014" REF PMP 4-6-18-80. Recall # Z-628-04; gg) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 6mm x 14mm 80 cm .014" REF PMP 4-6-14-80. Recall # Z-629-04; hh) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 5mm x 21mm 80 cm .014" REF PMP 4-5-21-80. Recall # Z-630-04; ii) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 5mm x 18mm 80 cm .014" REF PMP 4-5-18-80. Recall # Z-631-04; jj) ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System, 5mm x 14mm 80 cm .014" REF PMP 4-5-14-80. Recall # Z-632-04. REASON: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time. MANUFACTURER: ATS Medical, Inc, Minneapolis, MN, by letters dated February 18, 2004. Firm initiated recall is ongoing. PRODUCT: ATS Open Pivot Mechanical Heart Valve. Recall # Z-0634-04. REASON: Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position. MANUFACTURER: Beckman Coulter Inc, Brea, CA, by modified operating instructions on February 13, 2004. Firm initiated recall is ongoing. PRODUCT: a) CXP software, Part No. 623560. Recall # Z-0635-04; b) Cytomics MXP Software, Part No. 623688. Recall # Z-036-04; c) Cytomics RXP Software, Part Numbers: 175488, 6418489, 175260, 175261, 175262, 175263, 175264, 175265. Recall # Z-0637-04. REASON: Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date. MANUFACTURER: Datascope Corporation, Montvale, NJ, by letters on December 30, 2003. Firm initiated recall is ongoing. PRODUCT: HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; HEK08/75CPUT; HEK14/75CPUT; HEK08/120CPUT; HEK10/75CPUT; HEK25/100CPUT; HEK12/75CPUT; HEK10/150CPUT. Recall # Z-0638-04. REASON: Water permeability of the patch is out of specification. MANUFACTURER: Arrow International, Inc., Reading, PA, by letter dated February 18, 2004. Firm initiated recall is ongoing. PRODUCT: Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue Flex Tip Arrowgard Blue Curved Catheter for high Volume Ifusions. Recall # Z-0639-04. REASON: Catheter slips out of the suture wing during use. MANUFACTURER: Ross Products Division Abbott Laboratories, Columbus, OH, by telephone, fax, and FedEx on March 1, 2004. Firm initiated recall is ongoing. PRODUCT: a) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 0.8 cm length, Item Numbers: 53126 and 55602. Recall # Z-0642-04; b) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 1.0 cm length, Item Numbers: 53128 and 55604. Recall # Z-0643-04; c) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 1.2 cm length, Item Numbers: 53130 and 55606. Recall # Z-0644-04; d) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 1.5 cm length, Item Numbers: 53132 and 55608. Recall # Z-0645-04; e) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 1.7 cm length, Item Numbers: 53134 and 55610. Recall # Z-0646-04; f) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 2.0 cm length, Item Numbers: 53136 and 55612. Recall # Z-0647-04; g) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 2.3 cm length, Item Numbers: 53138 and 55614. Recall # Z-0648-04; Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube h) Kit, 14 Fr., 2.5 cm length, Item Numbers: 53140 and 55616. Recall # Z-0649-04; i) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 2.7 cm length, Item Numbers: 53142 and 55618. Recall # Z-0650-04; j) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 3.0 cm length, Item Numbers: 53144 and 55620. Recall # Z-0651-04; k) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 3.5 cm length, Item Number: 55622. Recall # Z-0652-04; l) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 4.0 cm length, Item Number: 55624. Recall # Z-0653-04; m) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 4.5 cm length, Item Number: 55626. Recall # Z-0654-04; n) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 0.8 cm length, Item Numbers: 54146 and 55628. Recall # Z-0655-04; o) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 1.0 cm length, Item Numbers: 54148 and 55630. Recall # Z-0656-04; p) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 1.2 cm length, Item Numbers: 54150, 55275, 55632. Recall # Z-0657-04; q) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 1.5 cm length, Item Numbers: 54152 and 55634. Recall # Z-0658-04; r) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 1.7 cm length, Item Numbers: 54154, 55636. Recall # Z-0659-04; s) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 2.0 cm length, Item Numbers: 54156 and 55638. Recall # Z-0660-04; t) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 2.3 cm length, Item Numbers: 54158 and 55640. Recall # Z-0661-04; u) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 2.5 cm length, Item Numbers: 54160 and 55642. Recall # Z-0662-04; v) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 2.7 cm length, Item Number: 55644. Recall # Z-0663-04; w) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 3.0 cm length, Item Number: 55646. Recall # Z-0664-04; x) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 3.5 cm length, Item Numbers: 54166 and 55648. Recall # Z-0665-04; y) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 4.0 cm length, Item Number: 55650. Recall # Z-0666-04; z) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 16 Fr., 4.5 cm length, Item Number: 55652. Recall # Z-0667-04; aa)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 0.8 cm length, Item Number: 55654. Recall # Z-0668-04; bb)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 1.0 cm length, Item Numbers: 54240 and 55656. Recall # Z-0669-04; cc)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 1.2 cm length, Item Numbers: 54242 and 55658. Recall # Z-0670-04; dd)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 1.5 cm length, Item Numbers: 54244 and 55660. Recall # Z-0671-04; ee)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 1.7 cm length, Item Numbers: 54246 and 55662. Recall # Z-0672-04; ff)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 2.0 cm length, Item Numbers: 54248 and 55664. Recall # Z-0673-04; gg)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 2.3 cm length, Item Numbers: 54250 and 55666. Recall # Z-0674-04; hh)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 2.5 cm length, Item Numbers: 54252 and 55668. Recall # Z-0675-04; ii)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 2.7 cm length, Item Number: 55670. Recall # Z-0676-04; jj)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 3.0 cm length, Item Numbers: 54256 and 55672. Recall # Z-0677-04; kk)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 3.5 cm length, Item Numbers: 54258 and 55674. Recall # Z-0678-04; Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube ll)Kit, 18 Fr., 4.0 cm length, Item Numbers: 54260 and 55676. Recall # Z-0679-04; mm)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 4.5 cm length, Item Numbers: 54262 and 55678. Recall # Z-0680-04; nn)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 0.8 cm length, Item Numbers: 54186 and 55680. Recall # Z-0681-04; oo)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 1.0 cm length, Item Number: 55682. Recall # Z-0682-04; pp)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 1.2 cm length, Item Numbers: 54190 and 55684. Recall # Z-0683-04; qq)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 1.5 cm length, Item Numbers: 54192 and 55684. Recall # Z-0684-04; rr)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 1.7 cm length, Item Numbers: 54194 and 55688. Recall # Z-0685-04; ss)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 2.0 cm length, Item Numbers: 54196 and 55690. Recall # Z-0686-04; tt)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 2.3 cm length, Item Number: 55692. Recall # Z-0687-04; uu)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 2.5 cm length, Item Numbers: 54200 and 55694. Recall # Z-0688-04; vv)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 2.7 cm length, Item Numbers: 54202 and 55696. Recall # Z-0689-04; ww)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 3.0 cm length, Item Numbers: 54204 and 55698. Recall # Z-0690-04; xx)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 3.5 cm length, Item Numbers: 54206 and 55700. Recall # Z=0691-04; yy)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 4.0 cm length, Item Numbers: 54208 and 55702. Recall # Z-0692-04; zz)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 4.5 cm length, Item Numbers: 54210 and 55704. Recall # Z-0693-04; aaa)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 1.5 cm length, Item Number: 55706. Recall # Z-0694-04; bbb)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 1.7 cm length, Item Numbers: 54214 and 55708.Recall # Z-0695-04; ccc)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.0 cm length, Item Number: 55711. Recall # Z-0696-04; ddd)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.3 cm length, Item Numbers: 54218 and 55713. Recall # Z-0697-04; eee)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.5 cm length, Item Numbers: 54220 and 55715. Recall # Z-0698-04; fff)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.7 cm length, Item Numbers: 54222 and 55717. Recall # Z-0699-04; ggg)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 3.0 cm length, Item Numbers: 54224 and 55719. Recall # Z-0700-04; hhh)Ross Hide-A-Port Low Profile Balloon Gastrostomy TubeKit, 24 Fr., 3.5 cm length, Item Numbers: 54226 and 55721. Recall # Z-0701-04; iii)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 4.0 cm length, Item Number: 55723. Recall # Z-0702-04; jjj)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 4.5 cm length, Item Numbers: 54230 and 55725. Recall # Z-0703-04. REASON: The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. MANUFACTURER: Smith And Nephew, Inc. Endoscopy Division, Andover, MA, by letter dated February 19, 2004. Firm initiated recall is ongoing. PRODUCT: a) Endocoupler, C-Mount 30 mm Focal Length Catalog Number: 7204823, 7204823S. Part No: 7204823. Recall # Z-0704-04. b) Endocoupler C-Mount 35 mmFocal Length Catalog Number: 6900398. Recall # Z-0705-04; c) Endocoupler 18 M M F.L, Autoclavable Catalog Number: 7207905, 7207905S. Recall # Z-0706-04; d) Endocoupler , C-Mount 35 mm Focal Length Catalog Number: 7204614, 7204614M, 7204614S. Recall # Z-0707-04; e) Endocpir, Zoom for Dyonics 3-Chip Camera Catalog Number: 7205461. Recall # Z-0708-04. REASON: Endocouplers assembled with screws that cannot be effectively sterilized . MANUFACTURER: Action Products Inc, Hagerstown, MD, by letter on January 19, 2003. Firm initiated recall is ongoing. PRODUCT: Xact(tm) Drop Seat Base, a plastic seat support in Xact(tm) Integrated and Xact Individual w/Drop seat Base Wheelchair cushions. Recall # Z-0709-04. REASON: Wheelchair seat may not properly support the user due to cracks in the plastic seat base. MANUFACTURER: Empath Medical, Inc., Plymouth, MN, by telephone and fax on February 26, 2004. Firm initiated recall is ongoing. PRODUCT: AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel-4 cm length, catalog No. 06506803. Recall # Z-0711-04. REASON: The product is labeled as sterile product but had not been sterilized. MANUFACTURER: Del Medical Systems Group, Franklin Park, IL, by letter dated February 13, 2004 and February 19, 2004. Firm initiated recall is ongoing. PRODUCT: DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray tube suspension system designed to facilitate a wide range of procedures. Recall # Z-0712-04. REASON: There is a potentially defective worm gear in the tension adjusting mechanism of the balancer used in the Digital Ceiling Mounted Tube Support System for overhead x-ray units. MANUFACTURER: Apex Surgical, LLC, Lakeville, MA, by letter on January 17, 2003. Firm initiated recall is complete. PRODUCT: a) Apex Pilot Shaft, 10mm, catalog number: 690110. Recall # Z-0713-04; b) Apex Pilot Shaft, 11.5mm, catalog number: 69011. Recall # Z-0714-04; c) Apex Pilot Shaft, 13mm, catalog number: 690113. Recall # Z-0715-04; d) Apex Pilot Shaft, 14.4mm, catalog number: 690114. Recall # Z-0716-04; e) Apex Pilot Shaft, 16mm, catalog number: 690116. Recall # Z-0717-04; f) Apex Pilot Shaft, 17.5mm, catalog number: 690117. Recall # Z-0718-04. REASON: Pilot shaft may break during reaming or broaching of the femur. MANUFACTURER: Stryker Howmedica Osteonics, Mahwah, NJ, by letters on February 10, 2004. Firm initiated recall is ongoing. PRODUCT: Restoration Hip system Cylindrical Distal Extension. Catalog numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions. Recall # Z-0719-04. REASON: The Cylindrical Distal Extensions were incorrectly coded and packaged. MANUFACTURER: 3M Company/Medical Division, St Paul, MN, by Product Recall Notice on February 27, 2004. Firm initiated recall is ongoing. PRODUCT: 3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, in boxes of 50 per box. Recall # Z-0720-04. REASON: The 3M Attest 1292 Rapid Readout Biological Indicators for steam sterilization may contain ampoules, which may result in a false negative readout as 3 hours. CLASS III MANUFACTURER: Medtronic Gastroenterology / Urology, Shoreview, MN, by letters dated February 6, 2004. Firm initiated recall is ongoing. PRODUCT: Medtronic Bravo pH Monitoring System Receiver. Recall # Z-0633-04. REASON: The product's rear panel label could smear during use causing the serial number to be unreadable. This has the remote possibility of resulting in patient data from diagnostic tests being mixed-up or attributed to the wrong patient. MANUFACTURER: Vysis, Downers Grove, IL, by telephone beginning on February 18, 2004. FDA initiated recall is ongoing. PRODUCT: ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Recurrence Kit; an invitro diagnostic; fixed, cultured normal human male lymphoblast cell line (negative target) and fixed culture human bladder carcinoma cell line specimens (positive), applied to glass microscope slides, catalog #30-805070, 3 slides per kit. Recall # Z-0640-04. REASON: Some of the control slides did not have adequate cells deposited upon their surface. MANUFACTURER: Gebauer Co., Cleveland, OH, by letter on February 23, 2004. Firm initiated recall is ongoing. PRODUCT: Salvart Oral Moisturizer, 2.5 fl oz. aerosol cans. OTC, Item number 0386-0009-75. Recall # Z-0641-04. REASON: The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 17, 2004 CLASS II MANUFACTURER: Stryker Howmedica Osteonics, Mahwah, NJ, by letters and accountability forms on December 30, 2003. Firm initiated recall is ongoing. PRODUCT: Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. LR3ST RESTORATION REV HIP SYS SURGICAL TECHNIQUE; 6262-7-000-0 RESTORATION REV HIP SYS TEMPLATE SET FOR STRAIGHT STEMS ONLY; LTEM71 1-9 RESTORATION REV HIP SYS 265MM BOWED STEM TEMPLATES; LTEM72 1-9 RESTORATION REV HIP SYS 305MM BOWED STEM TEMPLATES. Recall # Z-0571-04. REASON: Restoration T3 Revision Hip System distal stem has demonstrated fractures MANUFACTURER: Shelhigh, Inc., Union, NJ, by letter on December 19, 2003. Firm initiated recall is ongoing. PRODUCT: EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol. Recall # Z-0588-04. REASON: The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile. MANUFACTURER: Burton Medical Products Corp., Chatsworth, CA, by letter on January 30, 2004. Firm initiated recall is ongoing. PRODUCT: All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Recall # Z-0589-04. REASON: Pivot joint on these ceiling mount lights may fail and lights may fall onto patients. MANUFACTURER: Stereotaxis, Inc., Saint Louis, MO, by letter dated January 27, 2004. Firm initiated recall is complete. PRODUCT: a) Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001096-1. Recall # Z-0590-04; b) Cronus Endovascular Guidewire, Length 210 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-3. Recall # Z-0591-04; c) Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-4. Recall # Z-0592-04. d) Floppy Cronus Endovascular Guidewire, Length 180 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-3. Recall # Z-0593-04; e) Floppy Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001- Recall # Z-0594-04; f) Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1. Recall # Z-0595-04. REASON: The magnet at the end of the guidewire could break off. MANUFACTURER: AmeriSource Bergen, Chesterbrook, PA, by letter on January 28, 2004. Firm initiated recall is ongoing. PRODUCT: MediSense Precision QID Blood Glucose Test Strips. The product is sold in box of 50 and 100. The NDC number for the 50 count box is 57599-7400-4. The NDC number for the 100 count box is 57599-7401-5. Recall # Z-0596-04. REASON: Potential counterfeit product/box. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 10, 2004: CLASS II MANUFACTURER: General Electric Med Systems, Waukesha, WI, by letters dated February 6, 2004. Firm initiated recall is ongoing. PRODUCT: a) General Electric Seneographe 2000D Digital Mammography X-Ray System. Recall # Z-0282-04; b) General Electric Seneographe DMR Mammography X-Ray System (all versions). Recall # Z-0283-04; c) General Electric Seneographe 700T Mammography X-Ray System. Recall # Z-0284-04; d) General Electric Seneographe 800T Mammography X-Ray System. Recall # Z-0285-04; e) General Electric Seneographe 500 Mammography X-Ray Systems (all versions). Recall # Z-0286-04; f) General Electric Seneographe 600 Mammography X-Ray Systems (all versions). Recall # Z-0287-04. REASON: The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current. MANUFACTURER: Datex-Ohmeda, Inc., Madison, WI, by letters dated February 3, 2004. Firm initiated recall is ongoing. PRODUCT: Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly a product name change, with a slight color variation to the shade of white being used externally on the machine. There were no design or feature and function modifications when the name change occurred.) Recall # Z-0545-04. REASON: Anesthetic agents could be delivered at concentrations above the concentration set on the S/5 and AS/3 Anesthesia Delivery Units (ADU) having serial numbers within a specified range. MANUFACTURER: Weck, Research Triangle Park, NC, by letter, email, and fax beginning January 23, 2004. Firm initiated recall is ongoing. PRODUCT: Hem-o-Lok"SMX Ligating Clip, REF 544220, Non-absorbable Polymer Ligation Clips, Sterile EO, Single use, Disposable. Recall # Z-0547-04. REASON: Malformation of the Hem-o-lok SMK clip. MANUFACTURER: CryoLife Inc., Kennesaw, GA, by letter on December 10, 2003. Firm initiated recall is complete. PRODUCT: CryoValve Pulmonary Valve and Conduit. Donor #29640, Model #PV00 (Pulmonary Valve). Recall # Z-0548-04. REASON: As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered. MANUFACTURER: Becton Dickinson & Company, Franklin Lakes, NJ, by direct contact on December 22, 2003. Firm initiated recall is complete. PRODUCT: VACUTAINER Brand Push Button Blood Collection Sets. Recall # Z-0549-04. REASON: A hole was noticed in the blister pack that is used to package the device and provides the sterility barrier. Sterility could be compromised. MANUFACTURER: Abbott Laboratories Diagnostic Div, South Pasadena, CA, by letters on November 24, 2003. Firm initiated recall is ongoing. PRODUCT: Clinical Chemistry Urea Nitrogen. Recall # Z-0550-04. REASON: Low results due to contaminant. MANUFACTURER: Scion Cardio-Vascular, Inc., Miami, FL, by letter on May 23, 2003. Firm initiated recall is complete - 3 - PRODUCT: SCIPRO Flexible Stone Dislodger and Retrieval Set. Catalog #SP3000146ST. Recall # Z-0554-04. REASON: Possible difficulty for the user in opening the stone retrieval basket. MANUFACTURER: Instrumentation Industries, Inc., Bethel Park, PA, by telephone and letters dated September 17, 2003. Firm initiated recall is complete. PRODUCT: a) BE 183 Series Manual Jet Ventilator. Part #BE 183-SU. Recall # Z-0555-04; b) BE 183 Series Manual Jet Ventilator with Regulator and Gauge. Part #BE 183-SU. Recall # Z-0556-04. REASON: Possible external debris in the on/off plunger. MANUFACTURER: Scion Cardio-Vascular, Inc., Miami, FL, by letter on June 30, 2003. Firm initiated recall is complete. PRODUCT: SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other foreign objects during urological or gastroenterological procedures. Recall # Z-0557-04. REASON: The firm received field complaints that is was difficult to open the stone retrieval basket during use. MANUFACTURER: U&I America, Murray, UT, by letter on January 14, 2003. Firm initiated recall is complete. PRODUCT: a) 2.5mm Hex Driver. Recall # Z-0558-04; b) 4mm Hex Driver. Recall # Z-0559-04. REASON: Reports of hex driver tips breaking off or becoming worn or stripped. MANUFACTURER: Stryker Howmedica Osteonics, Mahwah, NJ, by letters dated January 9, 2004 and January 12, 2004. Firm initiated recall is complete. PRODUCT: Crossfire Acetabular II Insert. Catalog No. 2041C-2642. Recall # Z-0560-04. REASON: This device is not approved for sale in the U.S. MANUFACTURER: Cordis Corporation, Miami Lakes, FL, by letters on September 26, 2003. Firm initiated recall is complete. PRODUCT: a) The device is in a tyvek pouch and is labeled in part: Aviator Peripheral Dilatation Catheter REF Cat. No. Lot No., Use By Method of Sterilization ETO Min. Guiding Catheter ID Nominal Pressure Rated Burst Pressure. Recall # Z-0566-04; b) The device is labeled as Sterile and is packaged in a Tyvek pouch with the following labeling: PALMAZ Genesis TRANSHEPATIC BILIARY STENT on Aviator RX Delivery System REF Cat. No. Cordis ENDOVASCULAR Lot No., Recall # Z-0567-04. REASON: A packaging defect may compromise the device's sterility barrier. MANUFACTURER: Cardiocommand, Inc., Tampa, FL, by letter on October 31, 2003 and January 15, 2004. Firm initiated recall is ongoing. PRODUCT: AMS TAPSYSTEM Model 2A Esophageal Pulse generator (used in the Operating Room at Hospitals). Recall # Z-0568-04. REASON: The device may exhibit spurious heart rate increase during esophageal atrial pacing during simultaneous adjacent use of electrosurgical coagulation devices. MANUFACTURER: Smiths Medical ASD, Inc, Keene, NH, by telephone on December 12, 2003, and sales representative visits from December 12, 2003 through December 15, 2003. Firm initiated recall is ongoing. PRODUCT: PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080. Recall # Z-0569-04. REASON: Lid tray incorrectly labeled as Tube I.D.7.0mm instead of correct size 8.0mm. MANUFACTURER: Alpha-Omega Services, Inc., Bellflower, CA, by fax and telephone on September 4, 2003. Firm initiated recall is complete PRODUCT: Template Needle, Series 17, 20 cm, with Threaded Female hub and Bent Stylet, Closed-End, Disposable. Packaged in single, 10, 15, 20 per package. Recall # Z-0570-04. REASON: Template needle may fracture leaving tip in-patient. MANUFACTURER: Millipore Corp., Bedford, MA, by letter on January 26, 2004. Firm initiated recall is ongoing. PRODUCT: a) Millex-GS Syringe Filter Unit 0.22 um, Sterile Catalog Number: SLGSM33SS. Recall # Z-0573-04; b) Millex-HA Syringe Driven Filter Unit, 0.45 um, sterile Catalog Number: SLHAM33SS. Recall # Z-0574-04; c) Millex-AA Syringe Driven Filter 0.8 um, Sterile Catalog Number: SLAAM33SS. Recall # Z-0575-04; d) Millex GS- Syringe Filter 0.22um, Sterile Catalog Number: SLGS033SS. Recall # Z-0576-04. e) Millex HA Syringe Filter 0.45um, Sterile Catalog Number: SLHA033SS. Recall # Z-0577-04. REASON: Lack of assurance of sterility. MANUFACTURER: Rusch Inc., Duluth, GA, by letter and telephone on February 3, 2004. Firm initiated recall is ongoing. PRODUCT: a) 4-Way Tee with 2 one-way valves, Ref 395945 Lot***, SINGLE USE ONLY, Qty 1 ea. Carton labeling was similar to individual unit labeling, except for, ***Qty 50 ea. Recall # Z-0578-04; b) RFMD T-Piece With 2 one-way valves & tubing, Ref 395940, Lot***, SINGLE USE ONLY, Qty 1 ea. Carton labeling was similar to individual unit labeling, except for, ***Qty 50 ea. Recall # Z-0579-04; c) One Way Valve/Male to Female Flow, 22 mm I.D./22 mm O.D., Ref 396799, Lot ***, SINGLE USE ONLY, Latex Free, Quantity 50 Each. Recall # Z-0580-04; d) One Way Valve/Female to Male Flow, 22 mm I.D./22 mm O.D., Ref 396798, Lot ***, SINGLE USE ONLY, Latex Free, Quantity 50 Each. Recall Z-0581-04. REASON: Valve cap may become loose and enter the air circuitry. MANUFACTURER: Varian Medical Systems, Charlottesville, VA, by letters on February 2, 2004. Firm initiated recall is ongoing. PRODUCT: EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader. Recall # Z-0582-04. REASON: Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy. MANUFACTURER: Baxter Healthcare Renal Div., McGaw Park, IL, by letters dated February 20, 2004. Firm initiated recall is ongoing. PRODUCT: a) Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000. Recall # Z-0583-04; b) Baxter Arena Hemodialysis Delivery System. Recall # Z-0584-04. REASON: These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire. MANUFACTURER: Becton Dickinson Infusion Therapy, Sandy, UT, by telephone and letter on February 3, 2004. Firm initiated recall is ongoing. PRODUCT: a) BD First PICC Introsyte-N, 1.9Fr. x 50cm Single Lumen Procedure Kit. Catalog Number 384224. Recall Z-0586-04; b) BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile. Catalog Number 380402. Recall # Z-0587-04. REASON: Splittable catheter introducer may not fully split or may separate non-uniformly. CLASS III MANUFACTURER: Toshiba American Med Sys., Inc., Tustin, CA, by letters on January 28, 2004. Firm initiated recall is ongoing. PRODUCT: Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models. Recall # Z-0546-04. REASON: Software anomally causes image slices to be in incorrect order. MANUFACTURER: Pioneer Surgical Technology, Marquette, MI, by letter dated January 20, 2004. Firm initiated recall is ongoing. PRODUCT: Stayfuse brand intramedullary bone screw; MID 3.8x6 mm. Zimmer part number 00-2227-003-001. Recall # Z-0561-04. REASON: Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant. MANUFACTURER: C. R. Bard, Inc., Urological Division, Covington, GA, by letter on February 10, 2004. Firm initiated recall is ongoing. PRODUCT: Bardia® Complete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Inflate with 10ml sterile water, Contents: 5cc Silicone Elastomer-Coated Foley Catheter, Waterproof underpad, Synthetic Vinyl Gloves (2), Lubricant, 10cc Syringe (prefilled with sterile water to inflate Foley catheter), Povidone-Iodine swabs (3), CSR Wrap, Plastic Tray. Catalog Number: 800518. Recall # Z-0562-04. - 8 - REASON: The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling. MANUFACTURER: Boston Scientific Corporation, Natick, MA, by letter on January 28, 2004. Firm initiated recall is ongoing. PRODUCT: Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm, Catalog Number: 6965. Recall # Z-0563-05. REASON: Incorrect label states stent covered with "Permalume Covering", product is uncovered. MANUFACTURER: Cordis Corporation, Miami Lakes, FL, by Firm representatives visits the week of August 25, 2003, and by letters on August 29, 2003. Firm initiated recall is complete. PRODUCT: a) Cordis Endomyocardial Biopsy Forceps 7F 104 cm Standard, Product Number 504300L. Recall # Z-0564-04; Cordis Biopsy Forceps 7F 104 cm Standard, b) Product Number 504300L. Recall # Z-0564-04 REASON: Some devices may have incorrect inner label which shows Product # 504302L with a length of 50cm, while the outer label is correctly labeled as Product # 504300L with the length of 104mm. MANUFACTURER: Smiths Medical ASD, Inc., Keene, NH., by letter dated January 26, 2004. Firm initiated recall is ongoing. PRODUCT: Portex Tracheal Tube Guide 15 Fr, non-sterile, Catalog Number: 153013. Recall # Z-0572-04. REASON: Tracheal tube guide mislabeled as a 15 Fr instead of a 10 Fr. MANUFACTURER: Phoenix Biomedical, Norristown, PA, by letters on January 6, 2004. Firm initiated recall is complete. PRODUCT: Cruciform Slit Valve. Recall # Z-0585-04. REASON: Mislabeled: Product actually Single Valve. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 3, 2004: CLASS II MANUFACTURER: Weber Marking Systems, Arlington Heights, IL, by letter, on October 31, 2003. Firm initiated recall is complete. PRODUCT: CO2 Laser coding/marking machine. Solar Jet:e-SolarMark Laser. Recall # Z-0153-04. REASON: Labels missing. MANUFACTURER: Coherent, Inc, Santa Clara, CA, by technician visit to install software, by February 29, 2004. Firm initiated recall is complete. PRODUCT: Quattro FAP System, Class IV multi-wavelength laser diode
material processing machine. REASON: Performance requirement-safety interlocks malfunction due to improper information included in the software operating the laser MANUFACTURER: Magnivision, Inc., Miramar, FL, by e-mail dated April 16, 2003, and by telephone on May 2, 2003. Firm initiated recall is complete. PRODUCT: Magnivision UltraLights reading glasses which have the dioptic power on the label and "Magnivision and American Greetings Co. Recall # Z-0541-04. REASON: Possibility of eye injury from large tags on promotional sale product when customer tries them on in store MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by FedEx letter on December 17, 2003. Firm initiated recall is ongoing. PRODUCT: 18 Gauge thin wall needle as part of a Central Venous Catheter Kit. Recall # Z-0543-04. REASON: 18 gauge needles in Central Venous Catheter kits may be partially occluded. MANUFACTURER: DeRoyal Surgical Tray, New Tazewell, TN, by letter on January 19, 2004. Firm initiated recall is ongoing. PRODUCT: Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1, 46-703-1, 46-704-1; Type of Packaging: Tubes, dispenser box. Recall # Z-0544-04. REASON: Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed. CLASS III MANUFACTURER: Hardy Media Inc., Dba Hardy Diag., Santa Maria, CA, by telephone and letter on December 31, 2003. Firm initiated recall is ongoing. PRODUCT: Nitrate Reagent A, Cat No. Z71; Nitrate Reagent B, Cat. No. A72. Recall # Z-0542-04. REASON: Mislabeled. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 25, 2004: CLASS II MANUFACTURER: Welch Allyn Protocol, Inc., Beaverton, OR, by letter dated December 31, 2003. Firm initiated recall is ongoing. PRODUCT: Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00. Recall # Z-0538-04. REASON: Potential failure to audibly alarm due to speaker hardware component failure. MANUFACTURER: Staar Surgical Co., Inc., Monrovia, CA, by letters on February 9, 2004. FDA initiated recall is ongoing. PRODUCT: Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF. Recall # Z-0539-04. REASON: Risk of hyperopic refractive changes. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 18, 2004: CLASS II MANUFACTURER: Nihon Kohden America Inc., Foothill Ranch, CA, by letter, on December 5, 2003. Firm initiated recall is complete. PRODUCT: AG-920RA Multi-gas unit analyzer. Recall # Z-0506-04. REASON: Manufacturing error results in screw affecting electromagnetic interferences. MANUFACTURER: Cryolife Inc., Kennesaw, GA, by telephone on November 11, 2003, and by letter sent December 10, 2003. Firm initiated recall is ongoing. PRODUCT: CryoValve, Pulmonary Valve & Conduit. Recall # Z-0516-04. REASON: The firm received additional information from the procurement agency indicating that Yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis. MANUFACTURER: Laerdal Medical Corporation, Wappingers Falls, NY, by letters on January 14, 2004. Firm initiated recall is ongoing. PRODUCT: a) LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold as Part Nos: 870050-Adult Basic w/o Mask in Carton; 870051-Adult Complete in Carton; 870052-Adult Standard with Adult Mask 4-5+ in Carton; 870053-Adult Complete in Compact Case; 870055-Adult Complete in Display Case; 875500-b Adult Update Kit. Recall # Z-0517-04; b) LAERDAL Silicone Resuscitator (LSR), Pediatric Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 860050-Pediatric Basic w/o Mask in Carton; 860051- Pediatric Complete in Carton; 860052-Standard Child w/Child Mask 3-4 in Carton; 860053-Pediatric Complete in Compact Case; 860055-Pediatric Complete in Display Case; 860056-Standard Term-Baby w/Infant Mask 0-1 in Carton; 865500-Pediatric Upgrade Kit. Recall # Z-0518-04; c) LAERDAL Silicone Resuscitator (LSR), Preterm Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 850050-Preterm Basic w/o Mask in Carton; 850051-Preterm Complete in Carton; 850053-Preterm Complete in Compact Case; 850055-Preterm Complete in Display Case; 855500-Preterm Update Kit. Recall # Z-0519-04; d) Intake/Reservoir Valve (Part No. 875400), used in all sizes of Laerdal Silicone Resuscitators. Recall # Z-0520-04. REASON: Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative. MANUFACTURER: Medtronic, Inc., Danvers, MA, by telephone and email on January 14, 2004. Firm initiated recall is ongoing. PRODUCT: Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029. Recall # Z-523-04. REASON: Catheter distal tip may separate. MANUFACTURER: Stryker Medical, Kalamazoo, MI, by letters dated January 21, 2003. Firm initiated recall is ongoing. PRODUCT: a) Stryker brand Adel Maternity bed, model 4700, with night light. Recall # Z-0524-04; b) Stryker brand Firstcare Ultra Maternity bed, model 5010, with night light. Recall # Z-0525-04; c) Stryker brand Firstcare Ultra Maternity bed and Stryker brand Adel Maternity bed, 220 volt, model 5012, with night light. Recall # Z-0526-04. REASON: A potential shock hazard exists if the night-light is damaged. MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on January 16, 2004. Firm initiated recall is ongoing. PRODUCT: a) Synergraft CryoValve, Aortic Valve & Conduit SG. Donor #60525, Model #SGAV00. Recall # Z-0528-04; b) CryoValve, Pulmonary Valve & Conduit. Donor #69666, Model #PV00. Recall #Z-0529-04; c) CryoValve, Aortic Valve & Conduit. Donor #69666, Model #AV00. Recall # Z-0530-04. REASON: Microorganisms were detected in associated tissue. MANUFACTURER: Esaote Biomedica S.P.A., Indianapolis, IN, by letter dated December 23, 2003. Firm initiated recall is ongoing. PRODUCT: a) Esaote brand Archimed 4220 ECG System; part 9704220000. Recall # Z-0532-04; b) Esaote brand Formula for Archimed ECG System; part 9704220000. Recall # Z-0533-04; c) Esaote brand ArchiWin Colour ECG System; part 9704325000. Recall # Z-0534-04; d) Esaote brand Formul@ ECG System; part 9704220000. Recall #Z-0535-04. REASON: If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient. MANUFACTURER: Richard Wolf Medical Instruments Corp., Vernon Hills, IL, by telephone on February 2, 2004. Firm initiated recall is ongoing. PRODUCT: Pump Tube, Suction Pump Drain Tube; An accessory to the suction pump designed for use with the Richard Wolf Ultrasound Lithotriptor used to disintegrate kidney stones, urinary bladder stones and ureter stones. Recall # Z-0537-04. REASON: If the drain tube is assembled incorrectly, the suction pump will not operate as intended. CLASS III MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by visit beginning December 18, 2003. Firm initiated recall is ongoing. PRODUCT: a) Magnetom Trio System. Nuclear Magnetic Resonance Imaging Diagnostic Device. Recall # Z-0521-04. b) Magnetom Allegra System. Nuclear Magnetic Resonance Imaging Diagnostic Device. Recall # Z-0522-04. REASON: Tissue roll can become magnetic. MANUFACTURER: GVI Technology Partners, Twinsburg, OH, by letter on January 16, 2004. Firm initiated recall is ongoing. PRODUCT: CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version BIA. Recall # Z-0527-04. REASON: Due to limitations in the operating software, the acquired scan may not be processed properly. MANUFACTURER: Medtronic MiniMed, Northridge, CA, by Product Performance Update labeling in new shipments, starting on January 28, 2004. Firm initiated recall is ongoing. PRODUCT: Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software. Recall #Z-0531-04. REASON: A minor software anomaly results in an error in the calculation of the average glucose range that appears on one of the reports available in the model 7311 software. MANUFACTURER: Wilson-Cook Medical Inc., Winston Salem, NC, by letter on January 19, 2004. Firm initiated recall is ongoing. PRODUCT: Four Shooter Saeed Multi-Band Ligator. Reorder/Catalog number MBL-4XL. Recall # Z-0536-04. REASON: Product label lacks the symbols specifying the meaning of the manufacturing and expiration date. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 11, 2004: CLASS II MANUFACTURER: Stockwell Scientific, Inc., Scottsdale, AZ, by letter on December 30, 2003. FDA initiated recall is ongoing PRODUCT: 50 mL sterile plastic centrifuge tubes. Recall # Z-0512-04. REASON: Tubes are brittle and break during centrifuging specimens. MANUFACTURER: Diamedix Corporation, Miami, FL, by letter on December 9, 2003. Firm initiated recall is ongoing. PRODUCT: Product is packaged in a box and is labeled: Syphilis TREP-CHEX No. 720-100-10, 960 test, For in Vitro Diagnostic Use. Recall # Z-0513-04. REASON: The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results. CLASS III MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter dated 12/5/03. PRODUCT: a) TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Recall # Z-0507-04; b) TDx/TDxFLx REA Ethanol, list 9545-60; Recall # Z-0508-04; c) TDx/TDxFLx Salicylate, list 9533-60; Recall # Z-0509-04; d) TDx/TDxFLx Methadone, list 9676-60; Recall # Z-0510-04; e) Adx Methadone, list 9676-55; Recall # Z-0511-04 REASON: The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table. MANUFACTURER: Perkin Elmer Life and Analytical Sciences, Inc., Norton, OH, by letter on January 9, 2004. FDA initiated recall is ongoing. PRODUCT: a) Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000. Recall # Z-514-04; b) Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000. Recall # Z-515-04. REASON: The device is not stable throughout its labeled expiration date. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 4, 2004: CLASS II MANUFACTURER: General Electric Medical System, Waukesha, WI, by letter beginning on January 14, 2004. Firm initiated recall is ongoing. PRODUCT: Mammography X-Ray Systems. Recall # Z-0282/0287-04. REASON: The Mammography System's user information was missing the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current. MANUFACTURER: Drager Medical, Inc., Telford, PA, by letter dated January 9, 2003. Firm initiated recall is ongoing. PRODUCT: a) Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp. Recall # Z-0358-04; b) Drager Sola 700 Surgical Lamp and Steris Harmony LL 700 Surgical Lamp. Recall # Z-0359-04. REASON: The adjustment screw may break due to material fatigue. MANUFACTURER: Beckman Coulter Inc., Brea, CA, by letter on December 22, 2003. Firm initiated recall is ongoing. PRODUCT: ICON 25 h CG test kit. Recall # Z-0374-04 REASON: Test can exhibit false negative results. MANUFACTURER: Advanced Sterilization Products, Irvine, CA, by emails sent December 12, 2003 to December 19, 2003. Firm initiated recall is ongoing. PRODUCT: Cidex Plus Test Strips. Recall # Z-0375-04. REASON: Product may not accurately detect minimum effective concentration (MEC). MANUFACTURER: Baxter Healthcare Corp., Round Lake, IL, by letters dated December 17, 2003. Firm initiated recall is ongoing. PRODUCT: Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832. Recall # Z-0376-04. REASON: Premature motor failure. MANUFACTURER: Baxter Healthcare Corp., Round Lake, IL, by telephone December 16, 2003. Firm initiated recall is complete. PRODUCT: Micromix BCR Compounder, product code 2M8297; a pharmacy automation device with a barcode reader used in preparation of parenteral solutions. Recall # Z-0377-04. REASON: The compounder may omit an ingredient during the compounding process. MANUFACTURER: Staar Surgical Co, Inc., Monrovia, CA, by recall notice on January 6, 2004. FDA initiated recall is ongoing. PRODUCT: MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens). Recall # Z-0378-04. REASON: Increased numbers of lens tears during placement of lens into eye. MANUFACTURER: CVS, Woonsocket, RI, by letter and e-mail on November 19, 2003. Firm initiated recall is ongoing. PRODUCT: CVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses (hydrophilic) replaced in 30 days or less. Contains hydrogen peroxide as the disinfecting agent. 12 Fl. Oz (355 ML). (OTC) Item Number: 191648. Recall # Z-0379-04. REASON: Product label fails to provide adequate warning for use. MANUFACTURER: Kendall Healthcare Products Co., Mansfield, MA, by letters on January 8, 2004. Firm initiated recall is ongoing. PRODUCT: a) Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile 6 ply-4.5 in x 4.1 yd Product Number: 3331. Recall # Z-0380-04; b) Kendall Kerlix Large Roll, 4.5 in X 4.1 yd, Sterile Product Number: 6730. Recall # Z-0381-04; c) Kendall Curity Disposable Laparotomy Sponges, 12 in x 12 in, Sterile Product Number: 6034. Recall # Z-0382-04. REASON: Sterility compromised due to lack of package seal integrity. MANUFACTURER: Implant Innovations, Inc., by e-mail and fax on December 2, 2003. Firm initiated recall is ongoing. PRODUCT: a) Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labeled as follows: 3i Implant DC500 LOT 5.0mm Implant. Disposable Countersink Pilot Drill STERILE. Recall # Z-0383-04; b) Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labeled as follows: DDK315 LOT Disposable Drill Kit with DT315 STERILE. Recall # Z-0384-04; c) Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labeled as follows: DT220 2.3mm (D)x 20.0 mm (L) STERILE. Recall # Z-0385-04; d) Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labeled as follows: DT 310 LOT 3.0 mm (D) X 10.0 mm (L) STERILE. Recall # Z-0386-04; Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labeled as follows: DT423 LOT 4.25 mm (D) X 13.0 mm (L) Disposable Twist Drill STERILE. Recall # Z-0387-07. REASON: The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots. MANUFACTURER: Greiner VACUETTE North America, Monroe, NC, by letter or fax on December 16, 2003. Firm initiated recall is ongoing. PRODUCT: Holdex(r) + Butterfly, Blood Collection Set, Single use only. Sterile. Recall # Z-0388-04. REASON: Product may have a defective connection. CLASS III MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, via e-mail on December 16, 2003 and January 5, 2004 and by letters dated December 16, 2003 and December 31, 2003. Firm initiated recall is ongoing. PRODUCT: a) ARCHITECT(r) Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8 mL vials, Low Control L 2.5 ng/mL and Medium Control M 7.0 ng/mL; Recall # 0361-04; b) ARCHITECT Folate High Controls, List 6C12-11; the kit contains 8 - 1 mL vials of High Control H 15.0 ng/mL. Recall # 0362-04; c) ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL bottle of ARCHITECT Folate Manual Diluent containing TRIS buffer with protein stabilizer. Recall # 0363-04; d) ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles containing TRIS buffer with protein stabilizer, contained in ARCHITECT Folate Reagent Kit (Lists 6C12-20, 6C12-25, 6C12-30). Recall # 0364-04; e) AxSYM Folate Specimen Diluent, list 3C81-50, 10 mL bottles containing TRIS buffer with protein stabilizer. Recall # 0365-04; f) AxSYM Folate RBC Protein Diluent Pack, list 3C81-65; one 13 mL bottle contains human albumin. Recall # 0366-04; g) AxSYM Folate Medium Control Pack, list 3C81-11, the pack contains 8 - 1 mL vials of Medium Control M 7.0 ng/mL. Recall # 0367-04; h) Folate Low and High Controls, list 9C13-10; the pack contains 8 - 2 mL bottles( 4 for each level), Low Control L 2.5 ng/mL and High Control H 15.0 ng/mL. Recall # 0368-04; i) IMx Folate Medium Control, list 2220-11; the pack contains 8 - 1 mL bottles of IMx Folate Medium Control M 7.0 ng/mL. Recall # 0369-04; j) IMx Folate Mode 1 Calibrator Pack, list 2220-40, the pack contains 3 - 2 mL bottles of IMx Folate Mode 1 Calibrator 3.0 ng/mL. Recall # 0370-04; k) IMx Specimen Diluent Pack, list 2220-50; 1 - 10 mL bottle containing TRIS buffer with human albumin. Recall # 0371-04; l) IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate Reagent Pack, 100 tests, list 2220-20, and 100 Ion Capture reaction cells. Recall # 0372-04. REASON: There is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results. MANUFACTURER: Becton Dickinson & Co., Sparks, MD, by fax, e-mail, and letters on December 15, 2003. Firm initiated recall is ongoing. PRODUCT: Directigen (tm) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog # 256030. Recall # Z-0373-04. REASON: Diagnostic test kit may exhibit false positive results. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 28, 2004: CLASS II MANUFACTURER: Access CardioSystems, Concord, MA, by telephone and email on December 18, 2003 and December 19, 2003, and by letters dated December 19, 2003. Firm initiated recall is ongoing. PRODUCT: Access AED and Access ALS Automated External Defibrillators Model No. 9100-0100. Recall # Z-0356-04. REASON: Difibrillator may fail to operate due to a faulty component on the circuit board. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 21, 2004: CLASS II MANUFACTURER: Ethicon Endo-Surgery, Cincinnati, OH, by letter on November 25, 2003. Firm initiated recall is ongoing. PRODUCT: a) Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Standard, Product #ATB35. Recall # Z-0212-04; b) Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Vascular/Thin, Product #ATW35. Recall # Z-0213-04; c) FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD065. Recall # Z-0214-04; d) FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD063. Recall # Z-0215-04; e) FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #FBW24. Recall # Z-0216-04; f) FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD064. Recall # Z-0217-04; g) FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KBW16. Recall # Z-0218-04; h) FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KNB21. Recall # Z-0219-04; i) FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL22. Recall # Z-0220-04; j) General Laparoscopic Tray, Product #TGL33. Recall # Z-0221-04; k) General Laparoscopic Tray, Product #TGL53. Recall # Z-0222-04; l) FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL56. Recall # Z-0223-04; m) FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FN065. Recall # Z-0224-04; n) FlexTray Procedure Delivery System Endopath Gastric Tray, Product #KGB11. Recall # Z-0225-04; o) FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL45. Recall # Z-0226-04. REASON: A defective articulation band may result in improper staple formation with possible hematosis. MANUFACTURER: Alcon Laboratories, Inc., Fort Worth, TX, by letters, on November 18, 2003. Firm initiated recall is ongoing. PRODUCT: ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide. Recall # Z-0229-04. REASON: The patient bracelet that is given to patients post surgery after administering either ISPAN Perfluoropropane or ISPAN Sulfur Hexafluordie referred to the term, "stickoxid", which is the general term for nitrogen oxide and may be interpreted as either nitrogen monoxide (NO) or dinitrogen monoxide. The firm is recalling the old (blue) bracelets and replacing them with new (gray) bracelets that now reference the specific term dinitrogen monoxide N20 (laughing gas). MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letters dated November 12, 2003. FDA initiated recall is ongoing. PRODUCT: IMx Tacrolimus II Assay, list 3C10-20. Recall # Z-0230-04. REASON: Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances. MANUFACTURER: Medtronic Surgical Navigation Tech, Inc., Louisville, CO, by letter on November 1, 2003. Firm initiated recall is complete. PRODUCT: Fix pins associated with Stealth Station Treatment Guidance Platform. Recall # Z-0231-04. REASON: Surgical devices intended for single use were not labeled for single use. MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by facsimile on September 25, 2003. Firm initiated recall is ongoing. PRODUCT: Calculator/Data Processing Module for Clinical Use. Recall # Z-0235-04. REASON: Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks. MANUFACTURER: 3m Health Care, Saint Paul, MN, by letters dated October 24, 2003 and field correction. Firm initiated recall is ongoing. PRODUCT: a) 3M Attest 1264 Biological Indicators, in boxes of 100 per box. Recall # Z-0236-04; b) 3M Attest 1264P Biological Indicators, in boxes of 25 per box. Recall # Z-0237-04. REASON: The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant, which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to negative after 24 hours of incubation. MANUFACTURER: Misys Healthcare System, Tucson, AZ, by fax on July 21, 2003. Firm initiated recall is ongoing. PRODUCT: Misys Laboratory System. Recall # Z-0238-04. REASON: Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients. MANUFACTURER: Abbott Laboratories Diagnostic Div, South Pasadena, CA, by letter dated November 24, 2003. Firm initiated recall is ongoing PRODUCT: AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30. Recall # Z-0240-04. REASON: False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN. MANUFACTURER: Fisher & Paykel Healthcare, Inc., Laguna Hills, CA, by letter on December 5, 2003. Firm initiated recall is ongoing. PRODUCT: Phototherapy Lamp, Model 9001W501JE. Recall # Z-0241-04. REASON: Component placement presents risk of electrocution to patients. MANUFACTURER: Edwards Lifesciences AG, Haina, San Cristobal, DO, by letter on November 20, 2003. Firm initiated recall is ongoing. PRODUCT: VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood. Recall # Z-0242-04. REASON: Seal integrity, sterility not assured. MANUFACTURER: Cardinal Health, McGaw Park, IL, by letter dated November 3, 2003 and November 11, 2003. Firm initiated recall is ongoing. PRODUCT: Prolene Polyproplyene Mesh, 3" x 6", Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Recall # Z-0243-04. REASON: Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII. MANUFACTURER: Welch Allyn, Inc., Skaneateles Falls, NY, by letters dated October 27, 2003. Firm initiated recall is ongoing. PRODUCT: a) NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn "Tycos" and Allegiance "Tactics" labels. The "4" represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: Welch Allyn Tycos #5082-104-1 (10 pack/1 tube); Welch Allyn Tycos #5082-241-9 (5 pack/1 tube, multi-size pack); Allegiance Tactics #30502-113S (case of 40/1tube); Welch Allyn Tycos/Allegiance #5082-241-15 (5 pack/1 tube, multi-size pack); Recall # Z-0244-04. b) NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn "Tycos" and Allegiance "Tactics" labels. The "4" represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: Welch Allyn Tycos #5082-104-2 (10 pack/2 tubes); Welch Allyn Tycos #5082-104-2CL (10 pack/2 tubes, with clamp); Welch Allyn Tycos #5082-241-10 (5 pack/2 tubes, multi-size pack); Allegiance Tactics #30502-113 (case of 40/2 tubes); Allegiance Tactics #30502-213 (case of 40/2 tubes, with clamp); Welch Allyn Tycos/Allegiance #5082-241-16. Recall # Z-0245-04. REASON: Incorrect location of inflatable portion of cuff that may result in cuff falling off patient's arm, error code when used with patient monitor, or an inaccurate reading. MANUFACTURER: Q-Med Corporation, Ft Lauderdale, FL, by letter and telephone on October 30, 2003. Firm initiated recall is ongoing. PRODUCT: Product is a surgical device packaged in a box which is labeled as Sterile with the following identification: "PMII PROLENE Mesh Polypropylene Nonabsorbable Synthetic surgical Mesh ETHICON" Additional infomation including comparisons between authentic Ethicon product and counterfeit are available at the following website: Recall # Z-0246-04. REASON: This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark. MANUFACTURER: Smith And Nephew, Inc., Endoscopy Division, Andover, MA, by letter on October 15, 2003. Firm initiated recall is ongoing. PRODUCT: a) Smith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates unit previously serviced). Recall # Z-0247-04; b) Smith & Nephew Endocoupler C-Mount 35 mm Focal Length Reference : 7204614 and 7204614S (S indicates unit previously serviced). Recall # Z-0248-04. REASON: Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process. MANUFACTURER: McKesson General Medical Corporation, Richmond, VA, by e-mail on October 29, 2003 and recall notification on October 30, 2003. Firm initiated recall is ongoing. PRODUCT: PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3"x 6", each mesh in a sealed pouch package, 6 packages per papercard carton. Recall # Z-0249-04. REASON: Counterfeit product is an unapproved medical device with associated potential health hazard. MANUFACTURER: General Electric Medical Systems Information Technology, Milwaukee, WI, by letter dated November 10, 2003. Firm initiated recall is ongoing. PRODUCT: Solar 9500 Information Monitor. Recall # Z-0250-04. REASON: Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first. MANUFACTURER: Owens & Minor Distribution, Inc., Glen Allen, VA, by e-mail on October 31, 2003 and by letter on November 3, 2003. Firm initiated recall is ongoing. PRODUCT: PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3"x6", each mesh in a sealed pouch package, 6 packages per papercard carton. ***STERILE: Sterility of contents guaranteed unless package has been opened or damaged*** Recall # Z-0251-04. REASON: Counterfeit product is an unapproved medical device with associated potential health hazard. MANUFACTURER: Vital Concepts, Inc., Grand Rapids, MI, by letters dated November 7, 2003. Firm initiated recall is ongoing. PRODUCT: a) Irrigation aspiration system with double spike tubing and 33 cm probe, latex free, catalog # 55060. Sterile, single use. HYDRO-PRO brand and Quanta Technologies L.L.C. brand. Recall # Z-0258-04; b) Irrigation aspiration system for Nexhat Dorsey type pumps with 33 cm probe and tubing, latex free, catalog # 55050. HYDRO-PRO brand. Recall # Z-0259-04; c) Reorder # Lapkit 3. Contents: 1- 55060 suction/irrigation valve 2- 30012 insufflations tubing set 3- 5010 anti fog solution with sponge. Sterile. single use. Quanta Technologies L.L.C. brand. Recall # Z-0260-04; d) Auto Suture IRRIVAC MAX Suction irrigation system with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United States Surgical brand. Recall # Z-0261-04. REASON: The probe may separate from the cannula. MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on November 17, 2003. Firm initiated recall is ongoing. PRODUCT: a) The ARCHITECT i2000, Clinical Chemistry Analyzer. Recall # Z-0262-04; b) The ARCHITECT c8000, Clinical Chemistry Analyzer, Recall # Z-0263-04. REASON: Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234). MANUFACTURER: Bausch & Lomb, Inc., Rochester, NY, by a recall notification dated November 13, 2003. Firm initiated recall is ongoing. PRODUCT: CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes. Recall # Z- 0264-04. REASON: The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction. MANUFACTURER: Cardinal Health, McGaw Park, IL, by salesman visit on November 15, 2003 and by letter dated November 18, 2003. Firm initiated recall is ongoing. PRODUCT: Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ. Recall # Z-0266-04. REASON: The Namic Angiography Kit attached to the outside top of the Custom Sterile Pack is not sterile. MANUFACTURER: Stryker Medical, Kalamazoo, MI, by letters dated December 1, 2003. FDA initiated recall is ongoing. PRODUCT: Stryker brand Model 1550 Synergy Extended Stay Stretcher. Recall # Z-0267-04. REASON: The user may be pinched by the siderail when raising or lowering the siderail. MANUFACTURER: Philips Medical Systems Sales & Service Region No American, Bothell, WA. Firm initiated recall is ongoing. PRODUCT: Bucky Diagnostic FS Part number 9890-010-83651. Recall # Z-0268-04. REASON: Support chain attachment on the Bucky carriage may fail and cause the counter weights or X-ray tube to fall. MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by e-mail on November 23, 2003 and by letters dated November 24, 2003. FDA initiated recall is ongoing. PRODUCT: IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (100 tests - reagents alone). Recall # Z-0293-04. REASON: Chemotherapeutic concentrations of methotrexate in patient samples may carryover to subsequent samples, which would result in falsely elevated folate values, when performing IMx Folate testing. MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by telephone and letter on November 26, 2003. Firm initiated recall is ongoing. PRODUCT: Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Recall # Z-0298-04. REASON: Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results. MANUFACTURER: Bio-Med Devices, Inc., Guilford, CT, by telephone on November 7, 2003. Firm initiated recall is complete. PRODUCT: MVP-10 Pediatric/ Neonatal Volume Ventilator. Recall # Z-0300-04. REASON: Two way relief valve may fail to activate at the low negative pressure of -3cm H2O. MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letters dated December 19, 2003. Firm initiated recall is ongoing. PRODUCT: a) Hill-Rom Newborn bassinet; model P247. Recall # Z-0302-04; b) Hill-Rom Newborn bassinet; model P248. Recall # Z-0303-04. REASON: The caster/wheel may come off of the bassinet, causing the bassinet to tip. MANUFACTURER: Stryker Medical, Kalamazoo, MI, by letter dated December 30, 2003. Firm initiated recall is ongoing. PRODUCT: Stryker brand Synergy extended stay stretcher; model 1050. Recall # Z-0304-04. REASON: Users may be pinched in the side-rail assembly when raising or lowering the side-rail. MANUFACTURER: General Electric Med Systems, Waukesha, WI, by letter on December 8, 2003. Firm initiated recall is ongoing. PRODUCT: Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630. Recall # Z-0306-04. REASON: Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall. MANUFACTURER: I-Flow Corporation, Lake Forest, CA, by telephone on August 19, 2002 and by letter on August 27, 2002. Firm initiated recall is complete. PRODUCT: Eclipse Infusion Pump, 250 ml X 250 ml per hour) Part 5001247. Recall Z-0312-04. REASON: Slower than expected infusion of medications, such as antibiotics. MANUFACTURER: I-Flow Corporation, Lake Forest, CA, by letter on August 23, 2002. Firm initiated recall is complete. PRODUCT: Easypump LT 100-200 Elastomeric Infusion Pump (100 ml x 0.5 ml/hr) Part number: 5001120. Recall # Z-0313-04. REASON: Some pumps run at 2 ml/hr instead of 0.5 ml/hr. MANUFACTURER: C. R. Bard, Inc., Urological Division, Covington, GA, by letter on December 22, 2003. Firm initiated recall is ongoing. PRODUCT: a) Bard(r) Dimension(tm) Stone Basket, Rx only, Sterile. Recall # Z-0314-04; b) Bard(r) Platinum Class(tm) II Flat Wire Stone Basket, Ureteral Stone Dislodger, Rx only, Sterile. Recall # Z-0315-04. REASON: Product packaging may contain holes compromising sterility. MANUFACTURER: Biomerieux, Inc., Durham, NC, by letters dated October 28, 2003. Firm initiated recall is ongoing. PRODUCT: VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml LYT C2 (human) (negative control bottle), and 1 x 1.5 ml LYT S1 (human) (standard bottle). Recall # Z-0316-04. REASON: Kit may contain incorrect components. MANUFACTURER: Abbott Health Products, Inc., Barceloneta, PR, by letter dated November 17, 2003. Firm initiated recall is ongoing. PRODUCT: a) AxSYM Tricyclic Antidepressants Reagent. Recall # Z-0323-04; b) ADx Tricyclic Antidepressants Reagent. Recall # Z-0324-04; c) TDx/TDxFLx Tricyclic Antidepressants Reagent. Recall # Z-0325-04. REASON: Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay. MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letter on or about December 15, 2003. FDA initiated recall is ongoing. PRODUCT: a) Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R. Recall # Z-0326-04; b) Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R. Recall # Z-0327-04; Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591. Recall # Z-0328-04. REASON: If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume. MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letter dated December 29, 2003. Firm initiated recall is ongoing. PRODUCT: a) Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R. Recall # Z-0329-04; b) Roche brand OMNI 2 Analyzer; catalog numbers GD0335 and GD0335R. Recall # Z-0330-04; c) Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591.Recall # Z-0331-04; d) Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R . Recall # Z-0332-04; e) Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R. Recall # Z-0333-04; f) Roche brand OMNI 6 Analyzer; catalog numbers GD0415, GD0415R and GD041591. Recall # Z-0334-04; g) Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R. Recall # Z-0335-04; h) Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R.Recall # Z-0336-04; i) Roche brand OMNI 9 Analyzer; catalog numbers GD0475, GD0475R and GD047591. Recall # Z-0337-04. REASON: The firm is withdrawing claims that pleural, pericardial, ascetic and cerebrospinal fluids are appropriate sample types for use on these instruments. MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated December 26, 2003. Firm initiated recall is ongoing. PRODUCT: Hill-Rom brand Century+ bed; model P1400. Recall # Z-0338-04. REASON: If fluid is spilled on the siderail or the bed control areas, the bed may change positions without user input. MANUFACTURER: Plus Orthopedics, San Diego, CA, by telephone, on September 19, 2003. Firm initiated recall is ongoing. PRODUCT: Hip Stem, Sterile Pkg. The implant consists of 2 metal components, which fit together to form a femoral stem. Recall # Z-0339-04. REASON: Design Change. MANUFACTURER: Baxter Healthcare Corp., Round Lake, IL, by letters dated December 5, 2003 and December 8, 2003. Firm initiated recall is ongoing. PRODUCT: a) Baxter HomeChoice Automated PD Set with Lineo Connector, 4-prong, product codes R5C4479Q (English) and N5C4479Q (dual English/French label); 30 units per case. Recall # Z-0340-04; b) Baxter Lineo Opticap Disconnect Cap, product codes R5C4599Q (English) and N5C4599Q (dual English/French label); 30 units per case. Recall # Z-0341-04. REASON: Reports of loosening of the connections and disconnection of the device. MANUFACTURER: Invacare Corporation, Elyria, OH, by letter and telephone on December 15, 2003. Firm initiated recall is ongoing. PRODUCT: a) Invacare 2G Tarsys Seating System, Model 2GT. Recall # Z-0342-04; b) Invacare 2G Tarsys Seating System, Model 2GR. Recall # Z-0343-04; c) Invacare 2G Tarsys Seating System, Model 2GTR. Recall #Z-0344-04. REASON: The weld joints on the seat back may fail and cause possible injury to the patient. MANUFACTURER: Urologix, Inc., Minneapolis, MN, by letter on December 10, 2003. Firm initiated recall is ongoing. PRODUCT: Prostatron is a computer-controlled device designed to deliver microwave energy to the prostrate for the treatment of BPH (Benign Prostatic Hyperplasia). The Prostatron utilizes a transurethral microwave antenna, with simultaneous urethral cooling, to heat the prostate. This heating process is regulated through feedback from a series of temperature sensors. Recall # Z-0345-04. REASON: During treatment the Temperature Sensing System may change the rectal temperature reading by up to 2 degrees celcius and may briefly delay updates to the rectal temperature reading. MANUFACTURER: Bio Rad Laboratories, Inc., Redmond, WA, by letter on November 6, 2003. Firm initiated recall is ongoing. PRODUCT: Platelia Aspergillus EIA. Recall # Z-0348-04. REASON: Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan. MANUFACTURER: Toray Marketing & Sales (America), Inc., Houston, TX, by telephone and letter on January 2, 2004 and January 5, 2004. Firm initiated recall is ongoing. PRODUCT: a) Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H. Recall # Z-0349-04; b) Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6a. Recall # Z-0350-04; c) Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU. Recall # Z-0351-04; d) Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8. Recall #Z-0352-04. REASON: Potential loose header (end cap) on hollow fiber dialyzers. MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter dated December 15, 2003. Firm initiated recall is ongoing. PRODUCT: ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0. Recall # Z-0353-04. REASON: The calibrator lots may yield Free T4 values that are depressed. MANUFACTURER: Welch Allyn, Inc., San Diego, CA, by letters dated December 29, 2003. Firm initiated recall is ongoing. PRODUCT: Sure Temp Plus Model 690/692 Oral Temperature Probes. Recall # Z-0354-04. REASON: Mechanical setting errors that result in calibration errors. MANUFACTURER: Abbott Laboratories Diagnostic Div, South Pasadena, CA, by letters dated December 22, 2003. Firm initiated recall is ongoing. PRODUCT: Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30. Recall # Z-0355-04. REASON: Complaints that instructions for use were not clear. CLASS III MANUFACTURER: Boehringer Laboratories, Inc., Norristown, PA, by field representative visit on November 7, 2003. Firm initiated recall is ongoing. PRODUCT: Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. Model 7924. The product is shipped in cartons containing 6 units. Recall # Z-0227-04. REASON: Inadequate bond where the tube attaches to the inlet of the bulb. MANUFACTURER: Drug Free Enterprises, Inc., Agoura Hills, CA, by letters in April 2003. FDA initiated recall is complete. PRODUCT: DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET. Recall # Z-0239-04. REASON: Lacks professional use labeling and firm name and address. MANUFACTURER: Arrow International, Inc., Mount Holly, NJ, by letter on November 4, 2003. Firm initiated recall is ongoing. PRODUCT: a) Arrow A Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable Vascular Access System (Product # AP-06520) Product # AP-06520 kit contains 1 implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), straight non-coring needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case). Recall # Z-0254-04; b) Arrow A Port with Attachable Silicone Rubber Catheters Implantable Vascular Access System (Product # AP-01510). Product # AP-01510 kit contains 1 implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm) straight non-coring needle, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case). Recall # Z-0255-04; c) Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable (Product # AP-06042) [NB: titanium port]. Product # AP-06042 kit contains 1 low profile implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), injection needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case). Recall # Z-0256-04; d) Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable Vascular Access System (Product # AP-06022) [NB: plastic port] Product # AP-06022 kit contains 1 low profile implantable plastic port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), straight non-coring needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 - 18 - trays/case). Recall # Z-0257-04. REASON: The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided. MANUFACTURER: Medtronic MiniMed, Northridge, CA, by visit or FedEx software on CD-rom beginning on November 19, 2003. Firm initiated recall is ongoing. PRODUCT: Medtronic MiniMed. Model 7311 Solutions Pumps and Meters Software. Recall # Z-0265-04. REASON: Accessory software fails to report certain reports following download of data from 712 pump. MANUFACTURER: Polymedco, Inc., Cortlandt Manor, NY, by telephone on December 3, 2003 and by letter on December 5, 2003. Firm initiated recall is ongoing. PRODUCT: a) POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum. Recall # Z-0295-04; POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum. Recall # Z-0296-04. REASON: Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications. MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letters dated December 2, 2003. FDA initiated recall is ongoing. PRODUCT: Abbott Commander Flexible Pipetting Center (FPC) Operations Manual, list 6A97-27; Recall # Z-0297-04. REASON: The Operations Manual has the wrong Farenheit temperature range listed (102-122) instead of (104-122) for the preparation of the Terg-A-Zyme solution used to clean pipettes of the Abbott Commander Flexible Pipetting Center. MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letter and e-mail on December 3, 2003. Firm initiated recall is ongoing. PRODUCT: Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Recall # Z-0299-04. REASON: Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results. MANUFACTURER: Wilson-Cook Medical Inc, Winston Salem, NC, by letter on December 17, 2003. Firm initiated recall is ongoing. PRODUCT: Howell D.A.S.H. II Access System, Wire Guided Sphincterotome. Recall # Z-0301-04. REASON: Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label. MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter on November 19, 2003. Firm initiated recall is ongoing. PRODUCT: Pentalumen TD Thermodilution Catheter, Sterile. Recall # Z-0305-04. REASON: Thermodilution catheters have a potential for ruptured lumens within the catheter. MANUFACTURER: Heartport Inc, Somerville, NJ, by telephone on or about October 2, 2003. Firm initiated recall is ongoing. PRODUCT: a) EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. EndoReturn arterial cannula, 21 Fr. Product code ER21 (07043). The cannulas are also packaged in kits that have no specific lot number. The EndoReturn arterial cannula is packaged in the EndoCPB (Cardiopulmonary Bypass) System with Cardioplegia Catheter, Product codes ECPB211, 212, 213, 214, 231, 232. Also, the EndoCPB system without Cardioplegia Catheter, Product codes ECPB211, 212, 231, 232.Recall # Z-0307-04; b) EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. EndoReturn arterial cannula, 23 Fr. Product code ER23 (07044). Recall # Z-0308-04; c) DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. DirectFlow arterial cannula, 24Fr, Product Code DFK24 (06723). The cannulas are also packaged in kits that have no specific lot numbers associated. The kits are identified as the ENDODIRECT System, Product codes ED241, 242, 243, 244. Recall # Z-0309-04; d) SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoClamp-ST II aortic catheter. SoftClamp II arterial cannula, 24Fr. SCK (06724). Cannulas are also packaged in kits with no specific lot numbers associated. The kits is identified as SoftClamp System, Product Code SC-24. Recall # Z-0310-04; e) Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042). Recall # Z-0311-04. REASON: Damaged hemostasis valves that prevent or present difficulty when inserting catheters. MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter dated November 25, 2003. FDA initiated recall is ongoing. PRODUCT: a) AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 test kits. Recall # Z- 0318-04; b) Mx CA 125 Mode 1 Calibrator, list 7A89-40; Z-0319-04; c) CA 125 Calibrators, list 9C22-01; Z-0320-04; d) AxSYM CA 125 Master Calibrators, list 3B41-30. Recall # Z-0321-04; e) CA 125 Controls, list 9C22-10; Recall # Z-0322-04. REASON: The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the storage conditions, 69-6349/R2, refers to an outdated control package insert, 39-1642/R3, instead of the current control package insert 34-1047/R4. MANUFACTURER: Cardinal Health, Groveport, OH, by telephone and letter, on December 11, 2003. Firm initiated recall is complete. PRODUCT: Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only. Recall # Z-0346-04. REASON: The product was not held at the labeled storage temperatures, which could affect the product potency and/or physical properties, were distributed. MANUFACTURER: Wilson-Cook Medical Inc, Winston Salem, NC, by letter on December 19, 2003. Firm initiated recall is ongoing. PRODUCT: Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separately, Disposable - Single Use Only, Quality System ISO 9001 Certified, Rx Only, Recall # Z-0347-04. REASON: Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 14, 2004: CLASS II ****CORRECTION**** In the October 8, 2003 Enforcement Report, Recall # Z-1196-3, Disetronic H-TRON V100 Insulin Pump and Z-1197-3, Disetronic H-TRONplus Insulin Pump, and Z-1198-3, Disetronic D-TRONplus Insulin Pump, the recall actions were initiated by Roche Diagnostics Corp. not by FDA. Under RECALLING FIRM/MANUFACTURE the corrections are: Recalling Firm: Roche Diagnostics, Corp, Indianapolis, IN, Manufacturer: Disetronic Medical Systems AG. Firm initiated recall is ongoing. MANUFACTURER: Health Care Manufacturing, Inc., Springfield, MO, by telephone approximately May 15, 2003. FDA initiated recall is ongoing. PRODUCT: HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE. Recall # Z-0729-03. REASON: Required labeling (certification and manufacturer's label) was missing from the Operator Control Panels. MANUFACTURER: Power Medical Interventions, New Hope, PA, by recall notices on November 20, 2003. Firm initiated recall is ongoing. PRODUCT: a) SurgAssist System Circular Stapler DLU 29mm. Recall # Z-0252-04; b) SurgAssist System Circular Stapler DLU 33mm. Recall # Z-0253-04. REASON: Improper staple formation or anvil jam. MANUFACTURER: Datex-Ohmeda, Inc., Issaquah, WA, by letter dated October 31, 2003 was sent on October 29-31, 2003. Firm initiated recall is ongoing. PRODUCT: Spacelabs flat panel monitor, Model 91415-A. Recall # Z-0269-04. REASON: Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail. MANUFACTURER: Philips Medical Systems Sales & Service Region No. American, Bothell, WA, by letter on November 20, 2003. Firm initiated recall is ongoing. PRODUCT: a) Digital Diagnost VE. Recall # Z-0270-04; b) Philips Digital Diagnost VT. Recall # Z-0271-04. REASON: The support chain attachment on the detector carriage may fail and cause the counter weights or detector to fall. MANUFACTURER: Remel, Inc., Lenexa, KS, by letters dated October 29, 2003. Firm initiated recall is complete. PRODUCT: Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. Recall # Z-0273-04. REASON: Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area. MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on October 29, 2003. Firm initiated recall is ongoing. PRODUCT: The AXSYM System, Clinical Chemistry Analyzer. Recall # Z-0274-04. REASON: Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System MANUFACTURER: Hypoguard USA, Inc., Edina, MN, by letters dated November 26, 2003. Firm initiated recall is ongoing. PRODUCT: a) Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles. Recall # Z-0275-04; b) Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood Glucose Meter and 10 Hypoguard Advance Blood Glucose Strips. Recall # Z-0276-04 REASON: When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings. MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter dated November 17, 2003. FDA initiated recall is ongoing. PRODUCT: a) Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4. Recall # Z-0277-04; b) Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers 34-1074/R3 and 69-5120/R2. Recall # Z-0278-04; c) Package Insert for TDx/TDxFLx and TDxFLx Phenobarbital II Reagents, REF 9500, item number 69-5162/R4. Recall # Z-0279-04; d) Package Insert for TDx/TDxFLx and TDxFLx Vancomycin Reagents, REF 9523, item number 69-5726/R4. Recall # Z-0280-04. REASON: The package inserts contain incorrect values for the alternate unit (µmol/L) Control Ranges. MANUFACTURER: Novosci Corp., The Woodlands, TX, by telephone or email and letter on November 24, 2003. Firm initiated recall is ongoing. PRODUCT: Pediatric Air Aspirator Needle. Recall # Z-0281-04. REASON: The firm packaged Modified Air Aspirator Needles into Pediatric Air Aspirator Needle boxes. MANUFACTURER: Ohmeda Medical, A Division of Datex-Ohmeda, Inc., Laurel, MD, by letter and e-mail dated October 17, 2003. Firm initiated recall is ongoing. PRODUCT: Radiant Heater Door Vent for Ohmeda Medical's Giraffe (tm) OmniBed neonate bed. Recall # Z-0288-04. REASON: Heater vent door on neonatal incubator may malfunction. MANUFACTURER: Minolta Corp., Ramsey, NJ, by telephone on November 14, 2003. Firm initiated recall is ongoing. PRODUCT: a) Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 to 100), Pulse rate +/- 2%, Sp02 alarm, no, Probe type, finger, multi-site, Patient range adult to neonatal, memory function Approx. 24 hrs, printer/recorder optional accessory, output RS232 w/optional interface module, power supply 2 AAA batteries, Battery life approx. 48 hours, size: 42x68x20mm, weight 42g. Recall # Z-0289-04; b) Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message, error message, low Sp02 message, event mark. Measuring range Sp02 0 to 100, pulse rate 20 to 250, measuring accuracy Sp02 +/-2% (70 to 100), pulse rate +/- 2, Sp02 alarm, audible and visible, probe type finger, multi-site, paitent range adult to neonatal, memory function approx. 24 hrs, printer/recorder optional accessory, output RS232 w/optional interface module, power supply 2 AAA batteries, Battery life approx. 48 hrs, size 42x68x20mm, weight 42g. Recall # Z-0290-04. REASON: Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts. MANUFACTURER: Candela Laser Corp, Wayland, MA, by letter dated November 25, 2003. Firm initiated recall is ongoing. PRODUCT: Candela Smoothbeam Laser System Model Numbers: 9914-00-08209914-06-0820 9914-07-0820 9914-08-0820 9914-10-0820 Units are the same except for color. Recall # Z-0291-04. REASON: Laser may pulse and not dispense cryogen resulting in patient injury. MANUFACTURER: Guidant Cardiac Surgery, Santa Clara, CA, by letters on November 19, 2003. Firm initiated recall is ongoing. PRODUCT: Guidant Brand VasoView(r) 5 Harvesting Cannula System, Model Number: VH-1000. Recall # Z-0292-04. REASON: VasoView(r) 5 scissors are stiff and/or the scissor toggle has the potential to break during use. CLASS III MANUFACTURER: Edwards Lifesciences Corp., of Puerto Rico, Anasco, PR, by Sales Representatives contact on October 8, 2003. Firm initiated recall is ongoing. PRODUCT: Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only. Recall # Z-0272-04. REASON: Lot is being recalled because some of the kits contain an incorrect guidewire. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 7, 2004: CLASS II MANUFACTURER: Lorad, Danbury, Connecticut, by CPA letter December 23, 2003. Firm initiated recall is ongoing. PRODUCT: Lorad M-IV and Lorad M-IV Platinum mammography systems. Mammographic X-Ray systems to conduct mammography. Model Number: M-IV and M-IV Platinum. Recall # Z-0148/0149-04. REASON: System failed to meet the mAs accuracy specifications at low mAs values.
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