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FDA Recalls

January 7, 2004 - June 30, 2004

• Recalls as of June 30, 2004
• Recalls as of June 23, 2004
• Recalls as of June 16, 2004
• Recalls as of June 9, 2004
• Recalls as of June 2, 2004
• Recalls as of May 26, 2004
• Recalls as of May 19, 2004
• Recalls as of May 12, 2004
• Recalls as of May 5, 2004
• Recalls as of April 28, 2004
• Recalls as of April 21, 2004
• Recalls as of April 14, 2004
• Recalls as of April 7, 2004
• Recalls as of March 31, 2004
• Recalls as of March 24, 2004
• Recalls as of March 17, 2004
• Recalls as of March 10, 2004
• Recalls as of March 3, 2004
• Recalls as of February 25, 2004
• Recalls as of February 18, 2004
• Recalls as of February 11, 2004
• Recalls as of February 4, 2004
• Recalls as of January 28, 2004
• Recalls as of January 21, 2004
• Recalls as of January 14, 2004
• Recalls as of January 7, 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 CÆ 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 CÆ 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 ì0î 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 ìNutrition 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.
Recall # Z-0829-04; e) ABG Replacement Pump Assembly Catalog Number: 37092. Recall # Z-0830-04.

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;
j) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21 mm, Overall Length 54 cm, Coronary Sinus - Multi-Purpose Hook Tip Shape, CS-MPH, REF 7369. Recall # Z-0799-04; k) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21 mm, Overall Length 54 cm, Coronary Sinus - Hook Tip Shape, CS-H, REF 7438. Recall # Z-0800-04; l) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21 mm, Overall Length 54 cm, Coronary Sinus - Multi-Purpose Long Tip Shape, CS-MPL, REF 7507. Recall # Z-0801-04; m) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21 mm, Overall Lenght 54 cm, Coronary Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF 7576. Recall Z-0802-04; n) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21 mm, Overall Length 54 cm, Coronary Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF 7576. Recall # Z-0803-04; o) Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087", 2.21 mm, Overall Lenght 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592. Recall # Z-0804-04; p) Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087", 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592. Recall # Z-0805-04; q) Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087", 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Straight Right Tip Shape, CS-EH ST R, REF 7593. Recall # Z-0806-04.

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.
Recall # Z-0810-04.

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.
Recall # Z-0765-04.

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.
Recall # Z-0767-04;b) Zimmer brand Coonrad/Morrey total elbow interchangeable Ulnar assembly, small, right, 3 in. length, tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. No. 32-8105-53-02. Recall # Z-0768-04.

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.
Recall # Z-0769-04.

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.
Recall # Z-0772-04.

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
MANUFACTURER: Staar Surgical Co, Inc., Monrovia, CA, by visit beginning on February 23, 2004. Firm initiated recall is ongoing.

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,
Model # AVOO. Recall # Z-0775-04.

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.
Recall # Z-0153-04.

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;
e) NEONATE 3 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 # 5082-103-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9; Allegiance Healthcare "Tactics" label with Part # 30502-112S; and Arden label with Part # 5084-103-1. Recall # Z-0752-04; f) NEONATE 3 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 # 5082-103-2, 5082-102-2CL , and sold as part of a multi-pack (1 of each size) with Part #5082-241-10; Allegiance Healthcare "Tactics" label with Part # 30502-112 and 30502-212; and Arden label with Part # 5084-103-2, and 635-5084-103-2. Recall # Z-0753-04;g) NEONATE 4 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 # 5082-104-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9; Allegiance Healthcare "Tactics" label with Part # 30502-113S; and Arden label with Part # 5084-104-1. Z-0754-04;h) NEONATE 4 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 # 5082-104-2, 5082-104-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10; Allegiance Healthcare "Tactics" label with Part # 30502-113 and 30502-213; and Arden label with Part # 5084-104-2 and 636-5084-104-2. Recall # Z-0755-04;i) NEONATE 5 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 # 5082-105-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9; Allegiance Healthcare "Tactics" label with Part # 30502-114S; and Arden label with Part # 5084-105-1. Recall # Z-0756-04;j) NEONATE 5 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 # 5082-105-2, 5082-105-2CL, and sold as part of a multi- pack (1 of each size) with Part #5082-241-10; Allegiance Healthcare "Tactics" label with Part # 30502-114 and 30502-214; and Arden label with Part # 5084-105-2 and 637-5084-105-2. Recall # Z-0757-04.

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 an