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FDA Recalls

July 7, 2004 - December 22, 2004

• Recalls as of December 22, 2004

• Recalls as of December 15, 2004

• Recalls as of December 1, 2004

• Recalls as of November 24, 2004

• Recalls as of November 17, 2004

• Recalls as of November 10, 2004

• Recalls as of November 3, 2004

• Recalls as of October 27, 2004

• Recalls as of October 20, 2004

• Recalls as of October 13, 2004

• Recalls as of October 6, 2004

• Recalls as of September 29, 2004

• Recalls as of September 22, 2004

• Recalls as of September 15, 2004

• Recalls as of September 8, 2004

• Recalls as of August 25, 2004

• Recalls as of August 18, 2004

• Recalls as of August 11, 2004

• Recalls as of August 4, 2004

• Recalls as of July 28, 2004

• Recalls as of July 21, 2004

• Recalls as of July 14, 2004

• Recalls as of July 7, 2004

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 22, 2004:

CLASS I

MANUFACTURER: Unomedical, Inc., McAllen, TX, by Public Safety Alert on November 30, 2004, and letters and press release on December 2, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Hospitak, REF-903-GM, IPPB Circuit Exhalation Valve & Nebulizer Circuit Universal 4î Length with Adapter. Recall # Z-0279-05; b) Hospitak, REF-903-E, IPPB Ventilator Circuit. Recall # Z-0280-05; c) Hospitak, REF-1011, IPPB Ventilator Circuit. Recall # Z-0281-05; d) Hospitak, REF CD1N4Y-E, Mapleson D. Anesthesia Non-Rebreathing Circuit, 10î. Recall # Z-0282-05; e) Hospitak, REF CJ4N2Y-E, Jackson-Rees, Anesthesia Non-Rebreathing Circuit, 12î. Recall # Z-0283-05; f) Hospitak, REF CJ4N1VY-E, Jackson-Rees, Anesthesia Non-Rebreathing Circuit, 12î. Recall # Z-0284-05; g) Hospitak, REF 962-E, Adapter 22mm/15mm. Recall # Z-0285-05; h) Hospitak, REF 1450, Face Ten Mask w/Aerosol Tubing 60î, Oxygen Tubing 7î and Connector. Recall # Z-0286-5; i) Hospitak, REF 8026, Adapter 22mm/15mm. Recall # Z-0275-5; j) Viasys, REF BLD-14772, Pulmanex Adult Transport Ventilator Circuit with Exhalation Valve, Non-Heated, 72î. Recall # Z-0287-05; k) Viasys, REF BLD-14660, Pulmanex Adult Transport Circuit w/Exhalation Valve, Non-Heated, 60î. Recall # Z-0288-05; l) Viasys, REF BLD-1000, Pulmanex Adapter 22mm O.D. x 22mm O.D. x 15mm I.D. Recall # Z-0289-05; m) Viasys, REF BLD-8101, Pulmanex Carhill Valve Kit: Medium Adult. Recall # Z-0290-05; n) Viasys, REF BLD-8100, Pulmanex Carhill Valve Kit: Large Adult. Recall # Z-0291-05; o) Unomedical REF 962MM, Adapter 22mm/15mm. Recall #Z-0292-05; p) Drager Medical, REF 40314160, Bird-Bennet-Monaghan IPPB circuit, Latex Free. Recall # Z-0293-05.

REASON: Adapters have been found to be blocked or occluded ‚ potentially preventing exhalation or inhalation.

MANUFACTURER: Pulmonetic Systems, Inc., Minneapolis, MN, by telephone beginning on November 19, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Pulmonetic System Universal Cable Adaptor for use on LTV Series Ventilator, Model 800. Recall # Z-0274-05; b) Pulmonetic System Universal Cable Adaptor for use on LTV Series Ventilator, Model 950. Recall # Z-0294-05; c) Pulmonetic System Universal Cable Adaptor for use on LTV Series Ventilator, Model 900. Recall # Z-0295-05; d) Pulmonetic System Universal Cable Adaptor for use on LTV Series Ventilator, Model 1000. Recall # Z-0296-05.

REASON: The Universal Cable Adaptor, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.

CLASS II

MANUFACTURER: Smiths Medical ASD, Inc., Keene, NH, by letters dated September 9, and September 17, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Portex Hypodermic Needle-Pro 5 ml Syringe, 20g x 1 1û2î Needle Catalog Number: 4250. Recall # Z-0222-05; b) Portex Hypodermic Needle-Pro 5 ml Syringe, 20g x 1î Needle Catalog Number: 4251. Recall # Z-0223-05; c) Portex Hypodermic Needle-Pro 5 ml Syringe, 21g x 1 1û2î Needle Catalog Number: 4252. Recall # Z-0224-05; d) Hypodermic Needle-Pro 5 ml Syringe, 21g x 1î Needle Catatlog Number: 4253. Recall # Z-0225-05; e) Portex Hypodermic Needle-Pro 5 ml Syringe, 22g x 1 1û2î Needle Catalog Number: 4254. Recall # Z-0226-05; f) Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes Catalog Number: 4589P-1. Recall # Z-0227-05; g) Portex Tracheostomy Tube Decannulation Cap for use only with Fenestrated Tracheostomy Tubes Catalog Number: 519000, Recall # Z-0228-05; h) Portex Tracheostomy Tube Decannulation Cap for use only with Fenestrated Tracheostomy Tubes Catalog Number: 519000, Recall # Z-0228-05; i) Portex Lo-Profile Tracheostomy Tube Decannulation Cap Catalog Number: 582000, Recall # Z-0229-05; j) Portex Dual-Axis Swivel Adapter Catalog Number: 525151, Recall # Z-0230-05; k) Portex PEEP-KEEP Dual-Axis SwivelAdapter Catalog Number: 525351. Recall # Z-0231-05; l) Portex Single Swivel Adapter Catalog Number: 525451. Recall # Z-0232-05; m) Fiberoptic Bronchoscope Dual-Axis Swivel Adapter Catalog Number: 625191. Recall # Z-0233-05; n) Portex 3 Way Stopcock Catalog Number: T1102. Recall # Z-0234-05; o) Portex 3 Way Stopcock Catalog Number: T1103. Recall # Z-0235-05; p) Portex 3 Way Stopcock Catalog Number: T1202. Recall # Z-0236-05; q) Portex 3 Way Stopcock Catalog Number: T1203. Recall # Z-037-05; r) Portex 4 Way ìT-Handleî Stopcock Catalog Number: T1204. Recall # Z-0238-05; s) Portex 4-Way Stopcock Catalog Number: T1206. Recall # Z-0239-05; t) Portex ULTRA-FLO 4 - Way Stopcock Catalog Number: T1209.Recall # Z-0240-05; u) Portex ULTRA-FLO 4 ‚ Way Stopcock Catalog Number: T1210. Recall # Z-241-05; v) Portex High Pressure 1-Way Stopcock Catalog Number: T8200. Recall # Z-0242-05; w) Portex High Pressure 4 - Way Stopcock Catalog Number: T8202. Recall # Z-0243-05; x) Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1481. Recall # Z-0244-05; y) Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1483. Recall # Z-0245-05; z) Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1488. Recall # Z-0246-05; aa) Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1515.Recall # Z-0247-05; bb) Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1540. Recall # Z-0248-05; cc) Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1554. Recall # Z-0249-05; dd) Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1560. Recall # Z-0250-05; ee) Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1562. Recall # Z-0251-05; ff) Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1576. Recall # Z-0252-05; gg) Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1615. Recall # Z-0253-05; hh) Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1696. Recall # Z-0254-05; ii) Portex 1-Way Stopcock Catalog Number: T1201. Recall # Z-0255-05.

REASON: Sterility of the device is compromised due to packaging defects.

MANUFACTURER: Toshiba American Med Sys Inc., Tustin, CA, by letter on October 6, 2004. Firm initiated recall is ongoing.

PRODUCT: Magnetic Resonance Imaging Systems under the following names: Visart, Excelart, Excelart P2, Excelart P3, Excelart SPIN, Excelart VANTAGE. Recall # Z-0270-05

REASON: Software defect causes images to be rotated 180 degrees.

MANUFACTURER: B & K Medical Systems Inc., North Billerica, MA, by letter dated November 12, 2004. Firm initiated recall is ongoing.

PRODUCT: Linear Array Transducer Type: 8809. Recall # Z-0271-05.

REASON: Defect at probe tip may affect sterilization and electrical safety.

MANUFACTURER: Toshiba American Med Sys Inc, Tustin, CA, by letter on August224, 2004. Firm initiated recall is ongoing.

PRODUCT: Magnetic Resonance Imaging Systems, under the following names: Visart Excelart P2 Excelart P3 Excelart SPIN. Recall # Z-0273-05.

REASON: Software defect causes patient identification number to be truncated.

MANUFACTURER: Baxter Healthcare Corp., Deerfield, IL, by letters on May 28, 2003. Firm initiated recall is ongoing.

PRODUCT: Baxter System 1000 Single Patient Hemodialysis Delivery System, Model SYS1000; all series 1000 instruments labeled as System 1000. AltraTouch 1000, Baxter Tina and Baxter Aurora; Recall # Z-0274-05.

REASON: The air detector may not detect air bubbles consistently at the selected limit.

MANUFACTURER: Chembio Diagnostic System Inc., Medford, NY, by letters on October 6, 2004, October20, 2004 and November 9, 2004. Firm initiated recall is ongoing.

PRODUCT: a) OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the Sure Check hCG Midstream Pregnancy test consists of a lateral flow membrane pad containing anti-’ hCG monoclonal antibody conjugated to colloidal gold contained in a plastic ìwandî with an absorbent wick at one end. Catalog numbers are solely used for ordering by the different distributors. This OTC product is shipped as either bulk packaged product or as private labeled material labeled as follows: SURE CHECKô ONE STEP Pregnancy Test --- 1 TEST; UPC 6 07158 00110 3; Catalog # PT110SURE/12. SURE CHECKô ONE STEP Pregnancy Test --- 2 TESTS; UPC 6 07158 00112 7; Catalog # PT112/24. exactô pregnancy test. UPC 0 60383 66207 3; Catalog # PT110-N4 (Neuco). exactô pregnancy test --- 2 tests; UPC 0 60383 68179; Catalog # PT112-N4 (Neuco). OUR BEST NOTRE MEILLEUR ONE STEP PREGNANCY TEST (TEST DE GROSSESSE EN UNE ETAPE) --- 1 TEST --- UPC 0 61925 57608; Catalog # PT110-N7 (Neuco). BODY BASICSô Pregnancy Test (Test de grossesse) --- 1 Test --- UPC 0 57627 71110 9; Catalog # PT110-N6/12 (Neuco) Option+ TEST DE GROSSESSE UNE ETAPE/ONE STEP PREGNANCY TEST - UPC 7 71290 05402 7; Catalog # PT110-N2 (Neuco). True-Testô Pregnancy Test Kit (Examen del Embarazo) One Step Testing 1 Test - UPC 0 61406 37505 5; Catalog # PT110-R1 (Ultras). Shaw's ONE-STEP Pregnancy Test -1 TEST Made in USA; UPC 0 45674 65589 7; Catalog # PT110-S1. Harris Teeter Pregnancy Test Kits One Step ‚ Easy to use Pregnancy Test Kit --- Two Home Test Kits -UPC 0 72036 72061 0; Catalog # PT112-R2 (Harris Teeter). Bulk packaged product is assigned Catalog # PT110, with varying quantities 510(k) K961965. Recall # Z-0276-05; b) OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti-’ hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check Midstream product in that the lateral flow membrane pad is placed in a cassette and the urine sample is added by pipette rather than by urinating on the absorbent wick. The device is packaged in a foil pouch with desiccant. This product is shipped as bulk packaged product of varying quantities (Catalog # PT127-OTC; Catalog # PT210 ordered by LABSCO). 510(k) K933529/A. Recall # Z-0277-05.

REASON: Poor sealing of pouches and degradation of products. Investigation revealed invalid results (no control lines) and some false negatives.

MANUFACTURER: Power Surgical Solutions, Fort Worth, TX, by letter on November 11, 2004. Firm initiated recall is ongoing.

PRODUCT: Medtronic Midas Rex Legend High Speed Pneumatic System. Recall # Z-0278-05.

REASON: Softer hose increases the propensity for outer exhaust hose to kink or become occluded as a result of clamping.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letter dated November 5, 2004. Firm initiated recall is ongoing.

PRODUCT: MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Recall # Z-0297-05.

REASON: Test results may be adversely affected by software shutting down the cooling blocks in systems with software versions 3.09.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by verbally on July 28, 2004. Firm initiated recall is complete.

PRODUCT: CryoValve, Pulmonary Valve and Conduit. Recall # Z-0298-05.

REASON: The tissue donation was deferred due to possible Hepaititis C suspected by the MD.

MANUFACTURER: Baxter Healthcare Renal Div., Mc Graw Park, IL, by letters dated December 2, 2004. Firm initiated recall is ongoing.

PRODUCT: Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Recall # Z-0299-05.

REASON: The instrument power cord may become disconnected from the instrument and pose a fire or electrical shock hazard.

MANUFACTURER: Baxter Healthcare Renal Div., Mc Graw Park, IL, by letter dated November 5, 2004. Firm initiated recall is ongoing.

PRODUCT: Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m (48inch); a sterile set consisting of a bag connector (spike connector) on-off clamp assembly, tubing and double scaling male Luer lock connector; product code R5C4325. Recall # Z-0301-05.

REASON: Disconnection of the tubing at the clamp level of the UV Flash Transfer Set.

MANUFACTURER: Boston Scientific Corp, Glens Falls, NY, by telephone on October 21, 2004 and October 22, 2004, and by letters dated November 17, 2004. Firm initiated recall is ongoing.

PRODUCT: a) NAMIC Custom Angiographic Kit, Left Heart Kit- Model #H749651947220. Catalog # 65194722. Recall # Z-0302-05; b) NAMIC Custom Angiographic Kit, Left Heart Kit. Model #H7496019054110. Catalog # 601905411. Recall # Z-0303-05.

REASON: The kits contains defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub.

MANUFACTURER: Smith & Nephew Inc., Memphis, TN, by letter and email on June 21, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Genesis Uni Articular Inserts. Recall # Z-0304-05; b) Tibial Base Plates. Recall # Z-0305-05.

REASON: The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.

MANUFACTURER: Coherent, Inc., Santa Clara, CA, by letters on March 30, 2004. Firm initiated recall is ongoing.

PRODUCT: Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. Recall # Z-0360-05.

REASON: Software problem that may cause unintended emission of laser radiation.

- 9 - CLASS III

MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter, dated April 17, 2003. Firm initiated recall is ongoing.

PRODUCT: Intinion 1.5 T MRI Scanner. Recall # Z-0272-05.

REASON: There is a potential for the patient to be exposed to cryogenic fluids (liquid air) dripping from the vent during a quench due to the location of the vent.

MANUFACTURER: The Straumann Company, Waltham, MA, by letter dated November 11, 2004. Firm initiated recall is ongoing.

PRODUCT: Straumann Dental Implant System, SP Profile Drill, Short, 04-2 mm, RN, L25.0 mm, Stainless steel Ref. Number: 044.084. Recall # Z-0300-05.

REASON: Outside label incorrectly identifies drill as Regular Neck (RN) instead of Wide Neck (WN).

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 15, 2004:

CLASS I

MANUFACTURER: Tosoh Bioscience, Inc., San Francisco, CA, by telephone on April 2, 2003. Software upgrade was performed by firm’s Field Service Engineers. Firm initiated recall is complete.

PRODUCT: TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.02, Catalog Numbers 019359, 019400; Model 019400, Smart Media. Recall # Z-0218-05

REASON: A software upgrade was released by the firm for its AIA-600 II analyzers, in that washing deficiencies caused by the analyzer were corrected.

CLASS II

MANUFACTURER: Ideal Optics, Inc, Atlanta, GA, by letter on October 13, and November 8, 2004. Firm initiated recall is ongoing.

PRODUCT: IDEAL SOFT® (polymacon) Hydrophic contact lens, 62% poly (2-hydroxyethlymethacrytate). 38% water immersed in 0.9% sodium chloride solution. One sterile. Recall # Z-0221-05.

REASON: Lenses may not be sterile.

MANUFACTURER: Horizon Medical Products, Inc., Manchester, GA, by letter on September 20, 2004. Firm initiated recall is ongoing.

PRODUCT: LifePort®, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255. Catalog #LPS 7255m. Recall # Z-0256-05.

REASON: The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer.

MANUFACTURER: Medrad Inc., Indianola, PA, by letters dated November 1, 2004. Firm initiated recall is ongoing.

PRODUCT: Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK. Recall # Z-0257-05.

REASON: Sterility can be compromised by a tear in the outer packaging.

MANUFACTURER: Alsius Corporation, Irvine, CA, by firm representative on November 10, 2004. Firm initiated recall is complete.

PRODUCT: Alsius CoolGard 3000 patient temperature regulation system. Recall # Z-0258-05.

REASON: Product alarms that there may be a power supply interruption.

MANUFACTURER: Gaymar Industries, Inc, Orchard Park, NY, by letter dated October 25, 2004. Firm initiated recall is ongoing.

PRODUCT: XPRT Therapy Mattress Systems: Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without coating (standard cover). Responsible firm on the label: Manufactured for STRYKER MEDICAL, 6300 South Sprinkle Road, Kalamazoo, MI USA 49001-9799, 1-800-327-0770. The unit consists of a sleep surface, an integrated valve box located in the head of the mattress, a pump box located under the foot of the mattress and a color touch screen controller that can be mounted to either side of the pump box at the foot end of the mattress. Recall # Z-0260-05.

REASON: Design control/validation deficiencies.

MANUFACTURER: Trinity Biotech USA, Jamestown, NY, by letters dated November 1, 2004. Firm initiated recall is ongoing.

PRODUCT: AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers and calcium chloride. Recall # Z-0261-05.

REASON: Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on October 25, 2004. Firm initiated recall is ongoing.

PRODUCT: SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465. Recall # Z-0262-05.

REASON: Beckman Coulter has confirmed that occasionally a cuvette may be skipped during the SYNCHRON Lipase Wash (LIWA) procedure. If this occurs, there is the potential for carryover into the SYNCHRON Lipase (LIPA) assay, resulting in a substantial positive bias affecting Lipase (LIPA) results.

MANUFACTURER: DPC Cirrus, Flanders, NJ, by e-mail and fax on October 22, 2004. Firm initiated recall is ongoing.

PRODUCT: Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system. Recall # Z-0263-05.

REASON: Erroneous handling of samples will cause problems after the system is placed in “Sample-pause”.

MANUFACTURER: 3M Company/Medical Division, South St. Paul, MN, by letter dated November 5, 2004. Firm initiated recall is ongoing.

PRODUCT: 3M nexcare First Aid HoldFast Roll Gauze, Catalog number HF-2R. 1 Roll, 2 in. x 4.1 yards (stretched). Immediate product packaging (formed plastic with paper cover) contains no labeling. Recall # Z-0264-05.

REASON: Mislabeled - Nexcare Holdfast Roll Gauze were not sterilized, the product is labeled with "Sterility Guaranteed Unless Package is Opened or Damaged".

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on November 8, 2004. Firm initiated recall is ongoing.

PRODUCT: Access Immunoassay Systems, Discrete photometric chemistry analyzer. Recall # Z-0265-05.

REASON: A rare condition of the Access 2 Immunoassay Systems software versions 2.0, 2.1 and 2.2 could present a risk of an erroneous confirmatory result under a specific set of circumstances. The Chlamydia Blocking results may be affected. The instrument will erroneously perform the blocking calculation on the affected test by using the mean of the diluted and neat results.

MANUFACTURER: Becton Dickinson and Company, Sparks, MD, by letter on October 29, 2004. Firm initiated recall is ongoing.

PRODUCT: BD™ Phoenix™ ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708, packaged in cartons of 25 panels. Recall # Z-0268-05.

REASON: The foil pouch containing an in vitro diagnostic test kit for bacteria identification in patient samples may be defective and cause incorrect patient results.

CLASS III

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter of November 8, 2004. Firm initiated recall is ongoing.

PRODUCT: CXP software for Cytomics FC500 Cytometer. Recall # Z-0266-05.

REASON: Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letters on November 5, 2004. Firm initiated recall is ongoing.

PRODUCT: DL2000 Data Manager Software, Version 6.4.108. Recall # Z-0267-05.

REASON: Possibility of reporting an incorrect result occurs due to a software anomaly.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 1, 2004:

CLASS I

MANUFACTURER: Access Cardio Systems, Concord, MA, by letters on November 3, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Access AED (without audio record) Model Number: 9100-0100-0. Recall # Z-0199-05; b) Access AED Package (without audio record) Model Number: 9100-0150-0. Recall # Z-0200-05; c) Access AED (with audio record) Model Number: 9100-0100-1. Recall # Z-0201-05; d) Access AED Package (with audio record) Model Number: 9100-0150-1. Recall # Z-0202-05; e) Access ALS (Advanced Life Support) Model Number: 9100-0100-2. Recall # Z-0203-05; f) Access ALS Package Model Number: 9100-0150-2. Recall # Z-0204-05; g) Access AED PAD (without ECG trace) ‚Public Access Defibrillator Model Number: 9100-0010-0. Recall # Z-0205-05; h) Access AED PAD Package (without ECG trace) Model Number: 9100-0015-0. Recall # Z-0206-06.

REASON: Automated External Defibrillator device may fail to deliver shock due to a faulty circuit board.

CLASS II

MANUFACTURER: Pride Mobility Products Corp., Exeter, PA, by letter on May 14, 2004. Firm initiated recall is ongoing.

PRODUCT: Electric Positioning Lift Chairs. Recall # Z-0212-05.

REASON: The heating pad on these Lift Chairs may tear at the entry point causing a short and/or overheating, which can damage the chair.

MANUFACTURER: Power Surgical Solutions, Fort Worth, TX, by letter on November 3, 2004. Firm initiated recall is ongoing.

PRODUCT: Medtronic Midas Rex Legend Lubricant/Diffuser Cartridge Catalog number PA100-A. Recall # Z-0213-05.

REASON: Reduced plastic thickness of lubricant/diffuser cartridge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke

MANUFACTURER: Premier Dental Products Co., Plymouth Meeting, PA, by letters between May 2002 and March 2004. Firm initiated recall is ongoing.

PRODUCT: a) Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Instrument Recall # Z-0215-05; b) Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument. Recall # Z-0216-05.

REASON: Cryogen can escape from canister through the seal ring.

CLASS III

MANUFACTURER: Zeus Scientific, Inc., Somerville, NJ, by telephone and letter on August 30, 2004. Firm initiated recall is complete.

PRODUCT: Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropriate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box. Recall # Z-0214-05.

REASON: During packaging, Lyme plates were packaged in this kit in error

MANUFACTURER: Abbott Health Products, Inc., Barceloneta, PR, by letters dated October 27, 2004. Firm initiated recall is ongoing.

PRODUCT: IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls of 9 mL each. These are prepared with recalcified human plasma and the preservative is Sodium Azide. The Negative Control is non-reactive for HbsAG, HIV-1, Anti-HCV, anti-HiV-1/HIV-2 and IgG antibody against HAV. The Positive Control is recalcified human plasma for anti-HAV diluted with Negative Control. Recall # Z-0217-05.

REASON: IMx HAVAB Controls lot 18220Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package Insert.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 24, 2004:

CLASS II

MANUFACTURER: Software problem that may cause unintended emission of laser radiation.

PRODUCT: Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. Recall # Z-0540-04.

REASON: Software problem that may cause unintended emission of laser radiation.

MANUFACTURER: Baxter Healthcare Renal Div., McGaw Park, IL, by letters on November 1, and 2, 2004. Firm initiated recall is ongoing.

PRODUCT: a) HomeChoice and Yume Automated Peritoneal Dialysis Systems; catalog numbers 5C4471, 5C4471R, T5C4441,T5C4441R. Recall # Z-0188-05; b) HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis Systems; catalog numbers 5C8310, 5C8310R, T5C8300, T5C8300R. Recall # Z-0189-05.

REASON: The on/off power switch is not grounded as a separate component in the device, and can loosen from its housing, which may result in an electrical shock to the user.

MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by visit or telephone beginning October 18, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Safety Paracentesis Procedure Tray. Recall # Z-0190-05; b) Custom Convenience Kit. Recall Z-0191-05.

REASON: Merit Safety Paracentesis Procedure Trays and Merit Custom Convenience Kits contain Monoject Magellan safety needles which have been recalled by Tyco Healthcare. These needles may detach from their hub during use.

MANUFACTURER: Draeger Medical Inc., Telford, PA, by letter on September 15, 2004. Firm initiated recall is ongoing.

PRODUCT: APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia Machines. Recall # Z-0192-05

REASON: Rotating knob of the rotary style APL valve can become separated from the assembly.

MANUFACTURER: Baxter Healthcare Corp., Round Lake, IL, by letter dated April 28, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Baxter Clearlink Intravenous (IV) Delivery System; the system consists of solution sets, extension sets and blood sets that have a luer activated valve for IV access, which allows the administration of medications/solutions with a needleless luer syringe. Recall # Z-0193-05; b) Baxter Clearlink System Luer Activated Universal VIal Adapter, product code 2N8395. Recall # Z-0194-05.

REASON: Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device.

MANUFACTURER: Medex, Inc., Dublin, OH, by letters on October 20 and 21, 2004. Firm initiated recall is ongoing.

PRODUCT: MX20170: Pediatric 40 In Sampling Kit w/10cc syringe, MX20443: LogiCal Single Pressure Kit, MX20470: Pressure Monitoring Kit, MX20477: LogiCal Double Kit, MX20730: Double LogiCal Kit, MX20760: Neonatal 18'' Add-On Kit, MX20822: TranStar Monitoring Set, MX4033: Kids Kit 18in (45.7cm) Add-on Blood Sampling Kit, MX4037: Kids Kit Add-On Blood Sampling Kit, MX700376: TranStar Triple Monitoring Kit, MX700377: Double TranStar Kit, MX7781R1: St Judes Secure Kit, MX8004CSTT: Novatrans Mtring Kit 60 (152.4cm) Single Line, MX8033T: Novatrans Kids Kit Neonatal Mtring, MX9502CSTT: TranStar 72in (183cm) Secure Double Kit, MX9504CSTT: TranStar 60in (152cm) Secure Monitoring Kit, MX9505CSTT: TranStar 84in (213) Secure Monitoring Kit, MX9506CSTT: TranStar 72in Secure Triple Kit, MX9533T: TranStar Kids Kit Neonatal Monitoring Kit, MX9534T: TranStar Kids Kit, MX9537T: TranStar Kids Kit, MX9602CSTA: LogiCal 72in (183cm) Secure Double Kit, MX9604CSTA: LogiCal 60in (152cm) Secure Monitoring Kit, MX9605CSTA: LogiCal 84in (213cm) Secure Monitoring Kit, MX9606CSTA: LogiCal 72in (183cm) Secure Monitoring Kit, MX9607CSTA: LogiCal Triple Secure Kit, MX9634A: LogiCal Kids Kit Neonatal Monitoring Kit, MX9637A: LogiCal Kids Kit Neonatal Monitoring Kit, SX02: Sterile Sample. Recall # Z-0198-05.

REASON: Sampling port bodies on the device are cracking which can allow the sampling site to become dislodged from the body.

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by service bulletin dated August 12, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763. Recall # Z-0208-05; b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. Recall # Z-0209-05.

REASON: The central control monitor screen may go blank during use because of a bad wiring connection in the wiring harness or a low voltage setting on the potentiometer.

MANUFACTURER: Smiths Medical MD, Inc., Saint Paul, MN, by telephone, on September 18, 2004. Firm initiated recall is ongoing

PRODUCT: Deltec Cozmo Insulin Pump. Recall # Z-0210-05.

REASON: The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin Pumps may function intermittently.

MANUFACTURER: Animas Corp., West Chester, PA, by letter dated September 28, 2004. Firm initiated recall is ongoing.

PRODUCT: IR1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C. Recall # Z-0211-05.

REASON: Suspend mode not functioning properly.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on September 23, 2004. Firm initiated recall is ongoing.

PRODUCT: a) POLYSTAR, Angiographic X-Ray System, Model 1148902. Recall # Z-0195-05; b) POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505. Recall # Z--0196-05.

REASON: Orbital gears may exhibit excess wear.

MANUFACTURER: Tosoh Corporation, Tokyo, Japan. Firm initiated recall is ongoing. Recalling Firm: Tosoh Biosience, Inc., South San Francisco, CA, by letters on October 30, 2004.

PRODUCT: Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 10 trays of 20 test cups, Catalog #: 020271, For IN VITRO Diagnostic Use. Recall # Z-0197-05.

REASON: The Product may produce high reading in patientís values, which may lead to inappropriate treatment.

MANUFACTURER: Medtronic Inc, Cardiac Rhythm Management, Fridley, MN, by letter on October 20, 2004. Firm initiated recall is ongoing.

PRODUCT: Medtronic CapSureFix Novus Lead Model 5076. Recall Z-0207-05.

REASON: A specific lot of leads are labeled incorrectly. The leads are 45 cm in length and labeled as 52 cm lead length.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 17, 2004:

CLASS II

MANUFACTURER: Gillette Research Institute, Needham, MA, by letters on October 27, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Oral-B CrossAction Power Toothbrush, Soft (Battery Operated) Handle Colors: Blue, Pink, Green and Purple NDC 0-69055-82662-1. Recall # Z-0180-05; b) Oral-B CrossAction Power Toothbrush, Medium (Battery Operated) Handle Colors: Blue, Pink, Green and Purple NDC 0-69055-82445-0. Recall # Z-0181-05; c) Oral-B CrossAction PowerMAX Rechargeable Toothbrush, Soft 4 Accent Colors: Blue, Pink, Green and Purple NDC 0-69055-83293-6. Recall # Z-0182-05; d) Oral-B CrossAction PowerMAX Rechargeable Toothbrush, Medium NDC 0-69055-83120-5. Recall # Z-0183-05; e) Oral-B CrossAction Power Brushhead Refills, Soft 2-Count Pack NDC 0-69055-82663-8. Recall # Z-0184-05; f) Oral-B CrossAction Power Brushhead Refills, Medium 2-Count Pack NDC 0-69055-82448-1. Recall # Z-0185-05.

REASON: Brushhead may unlatch from the power handle.

CLASS III

MANUFACTURER: Diopsys Inc., Metuchen, NJ, by letter on September 14, 2004. Firm initiated recall is ongoing.

PRODUCT: The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device. Each medical device unit is assembled and contains an 18 inch flat panel vision stimulator panel, a 17 inch flat panel operator monitor, a 2.25 inch thermal printer, a mobile point of care cart, medical grade battery back-up, speaker, a CPU with floppy and CD drives, a camera and an isolation transformer. Recall # Z-0186-05.

REASON: The firm has not established a medical device quality system, a quality plan, nor quality procedures.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 10, 2004:

CLASS II

MANUFACTURER: GE OEC Medical Systems, Salt Lake City, UT, by firm representative visit implementing Field Modification Instruction 15019 beginning on October 14, 2004. Firm initiated recall is ongoing.

PRODUCT: a) X-ray system GE OEC Series 7600. Recall # Z-1067-04; b) Compact Series 7600. Recall # Z-1068-04.

REASON: The x-ray product failed to comply with the Federal x-ray product performance standard, whereby unintended x-rays are emitted upon boot-up if the footswitch is engaged.

MANUFACTURER: Shimadzu Corp., Torrance, CA, by service representative visit beginning on October 22, 2004. Firm initiated recall is ongoing

PRODUCT: MUX-100H Mobile Radiography System. Recall # Z-1486-04

REASON: The spacer hardware does not maintain the proper minimum distance allowed

MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by telephone and letter on September 14, 2004. Firm initiated recall is ongoing.

PRODUCT: a) 8 ml Inject8 Coronary Control Syringe, sterile. Product Number CCS880. Recall # Z-0048-05; b) 10 ml Inject 10 Palm Pad, sterile, Product Number CCXB010/A. Recall # Z-0049-05; c) Convenience Kits containing Inject8 or Inject10 syringes. Recall # Z-0050-05.

REASON: Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.

MANUFACTURER: Advanced Sterilization Products, Irvine, CA, by letters on April 23, 2004 and May 7, 2004. Firm initiated recall is ongoing.

PRODUCT: CIDEX OPA Solution, ortho-Phthalaldehyde Solution. Recall # Z-0051-05.

REASON: Anaphylactic-like reactions were reported following repeated cystoscopy for bladder cancer patients where the scope had been reprocessed in CIDEX OPA Solution.

MANUFACTURER: Becton Dickinson and Company, Franklin Lakes, NJ, by a Technical Bulletin on September 17, September 23, 2004 and October 5, 2004. Firm initiated recall is ongoing.

PRODUCT: BD Vactuainer SST glass and plastic tubes. Recall # Z-0052-05.

REASON: There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and adrenal gland function. The immunoassay results are high when BD serum separator tubes are used in certain instruments platforms.

MANUFACTURER: BioMerieux, Durham, NC, by letter on August 20, 2004. Firm initiated recall is ongoing.

PRODUCT: a) MDA® Fibriquik™. Recall # Z-0053-05; b) Fibriquik™. Recall # Z-0054-05.

REASON: Complaints were received from the field regarding prolonged clot times, high control values and erratic results.

MANUFACTURER: Fujifilm Medical System USA, Inc., Stamford, CT, by letter dated September 30, 2004. Firm initiated recall is ongoing.

PRODUCT: Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344. Recall # Z-0055-05.

REASON: Model GP344 may detach from the mounting block and fall during use.

MANUFACTURER: Thomas Medical Products Inc., Malvern, PA, by letter on October 15, 2004. Firm initiated recall is ongoing.

PRODUCT: a) SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units. Recall # Z-0056-05; b) SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1009. The product is shipped in cartons containing 5 units. Recall # Z-0057-05; c) SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1011. The product is shipped in cartons containing 5 units. Recall # Z-0058-05.

REASON: Sheaths may fracture if exposed to excess fluorescent light.

MANUFACTURER: K C Pharmaceuticals, Inc., Pomona, CA, by letters on October 4, 2004. Firm initiated recall is ongoing.

PRODUCT: Sterile Multi-Purpose Solution, NO RUB, for soft hydrophilic contact lenses. 12 fl oz. bottles. Sold under the following brand names: Family Dollar HomeBest HEB Meijer Food Lion health PRIDE Stop and Shop Super G sunmark Brite-Life Wegmans Our Family Healthy Generations GoodSense Winn Dixie Finast Western Family K C Pharmaceuticals. Recall # Z-0060-05.

REASON: Routine testing indicates product does not meet the expiration date in all cases.

MANUFACTURER: Infusion Dynamics, A Div. Of Zoll Med Corpinfusion Dynamics, Plymouth Meeting, PA, by letter dated September 20, 2004. Firm initiated recall is ongoing.

PRODUCT: Infusion Dynamics Power Infuser pump. Model number M100B-3A. Recall # Z-0062-05.

REASON: Front Panel may be cracked on some units. If cracked fluid can enter the infuser and short the start/stop button. Shorting would cause the infuser to stay in the open position.

MANUFACTURER: Philips Medical Systems, Andover, MA, by letter on September 13, 2004. Firm initiated recall is ongoing

PRODUCT: Pagewriter Touch Cardiograph Software. Recall # Z-0063-05.

REASON: Software can generate printed ECG's that associate incorrect patient data with the waveform.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on September 28, 2004. Firm initiated recall is ongoing.

PRODUCT: a) SOMATOM CT System Emotion Duo, X-Ray, Tomography, Computed System, Model number 38 13 933. Recall # Z-0156-05; b) SOMATOM CT System Emotion 6, Computed Tomography X-Ray System,Model Number: 38 15 490. Recall # Z-0157-05; c) SOMATOM CT System Sensation 16, Computed Tomography X-Ray, Model Number 73 93 114. Recall # Z-0158-05; d) SOMATOM CT System Sensation 16 (+ Straton), Computed Tomography System, Model Number 73 93 114. Recall # Z-0159-05; e) SOMATOM CT System Sensation Cardiac, Computed Tomography X-Ray, Model Number 75 43 106. Recall # Z-0160-05; f) SOMATOM CT System Sensation Cardiac (+ Straton), Computed Tomography X-Ray System, Model Numbers 75 43 106. Recall # Z-0161-05; g) SOMATOM CT System Sensation 10, Computed Tomography X-Ray System, Model Number 75 43 015. Recall # Z-0162-05; h) LEONARDO MM-WS, Computed Tomography X-Ray, Model Number 71 29 534. Recall # Z-0163-05.

REASON: Calcium Scoring feature on the devices is not closing properly after patient's exams.

MANUFACTURER: 1-800 Contacts Inc., Draper, UT, by letter on October 13, 2004. Firm initiated recall is ongoing.

PRODUCT: Counterfeit contact lenses labeled as: "CooperVision Proclear compatibles (omafilcon A)". Labeling on outer box reads in part: "CooperVision proclear compatibles (omafilcon A) ***Norfolk, VA *** MADE IN USA ** Tinted soft contact lenses *** in a buffered 0.9% saline solution***". Recall # Z-0164-05.

REASON: Identified lots of Proclear Compatible contact lenses are counterfeit and may not be sterile.

MANUFACTURER: CryoLife, Inc., Kennesaw, GA, by letter on/about May 6, 2004. Firm initiated recall is ongoing.

PRODUCT: a) CryoValve, Pulmonary Valve & Conduit. Recall # Z-0165-05; b) CryoValve, Aortic Valve & Conduit. Recall # Z-0166-05; c) Alt Pulmonary Valve & Conduit. Recall # Z-0167-05; d) CryoValve, Aortic Valve. Recall # Z-0168-05; e) CryoValve, Pulmonary Valve & Conduit - SG. Recall # Z-0169-05; f) CryoValve, Aortic Valve & Conduit w/o AML. Recall # Z-0170-05; g) CryoValve, Pulmonary Valve. Recall # Z-0171-05; h) CryoValve, Aortic Valve & Conduit SG. Recall # Z-0172-05; i) Alt. Aortic Valve & Conduit. Recall # Z-0173-05

REASON: CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.

MANUFACTURER: Stryker Instruments, Div. Of Stryker Corp., Kalamazoo, MI, by letter dated November 9, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Stryker brand Neptune waste management system, Neptune Rover, 20 amp plug; model 0700-001-000. Recall # Z-0174-05. b) Stryker brand Neptune waste management system, Neptune Rover, 15 amp plug; model 0700-003-000. Recall # Z-0175-05.

REASON: The grounding pin may break inside of the electrical plug, resulting in a shock hazard.

MANUFACTURER: ela Medical Llc, Plymouth, MMN, by letter, on October 21, 2004. Firm initiated recall is ongoing.

PRODUCT: Alto and Alto 2 implantable cardioverter defibrillator. Recall # Z-0176-05.

REASON: These models can experience sudden no output, and early end of life characteristics due to metal migration in their controlling hybrids, causing high current drain leading to premature battery depletion.

MANUFACTURER: Medical Industries America, Inc., Adel, ID, by telephone on September 7, 2004 and October 1, 2004 and by letters between September 24-28, 2004. Firm initiated recall is ongoing.

PRODUCT: Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): Model 7000 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; Model 7030 - Consisting of the Aeroneb Go, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7070 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7000-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, European mask elbow, mouthpiece, carry bag, and user manual; Model 7030-1 - Consisting of the Aeroneb Go, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual; Model 7070-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual. 7000LINCARE - Consisting of the Aeroneb Go, battery controller with a Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; 7070LINCARE - Consisting of the Aeroneb Go, battery controller with the Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual. Recall # Z-0177-05.

REASON: The nebulizer can either fail or provide a low flow (partial dose) of medication.

MANUFACTURER: Philips Ultrasound, Inc., Bothell, WA, by letter on September 6, 2004. Firm initiated recall is ongoing.

PRODUCT: HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system). Recall # Z-0178-05.

REASON: Potential for device to cause burning of the skin.

MANUFACTURER: Cardinal Health, Medical Products & services, McGaw Park, IL, by letter dated October 27, 2004. Firm initiated recall is ongoing.

PRODUCT: V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a sterile, single use kidney stone retriever device; Product code GU6397. Recall # Z-0179-05.

REASON: The dispenser box was mislabeled with the wrong length and the wrong wire gauge.

CLASS III

MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated July 28, 2004. Firm initiated recall is ongoing. - 8 -

PRODUCT: VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma. Recall # Z-1473-04.

REASON: The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.

MANUFACTURER: Perkin Elmer LAS Inc., Norton, OH, by letter dated September 14, 2004. Firm initiated recall is ongoing.

PRODUCT: RESOLVE Hemoglobin Test Kits. Kit codes: FR-9120 -- 120 tests per kit; FR-9400 -- 360 tests per kit; and FR-9360 --3600 tests per kit. Recall # Z-0047-05.

REASON: The product insert for the test kits is incorrect with regard to the acceptable storage temperature for the Agarose IEF gel component. The kit and IEF gel labels indicate the correct storage temperature of 2-8 degrees C. The product insert incorrectly indicates that the product may be stored

MANUFACTURER: Arrow International, Inc., Reading, PA, by letter dated September 27, 2004. Firm initiated recall is ongoing.

PRODUCT: Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+ard Blue Plus Catheters. The plus indicates that the line extension clamps are attached to the catheters. Recall # Z-0059-05.

REASON: Labeling error. Kits contains the correct components for AK-42802-SK but may have a package label indicating that it is product number AK-22802-SK.

MANUFACTURER: Toshiba American Med Systems, Inc., Tustin, CA, by letter on September 29, 2004. Firm initiated recall is ongoing.

PRODUCT: Excelart™ VANTAGE P2 & P3, Magnetic Resonance Imaging System. Recall # Z-0061-05.

REASON: Scanned images are acquired at a position that is shifted relative to the intended position in the slice direction due to a software anomaly.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 3, 2004:

CLASS II *****CORRECTION***** The Enforcement Report of October 27, 2004 which reported the Becton Dickinson recall of DifcoBBL Gram Crystal Violet, Recall # Z-0025-05 has been corrected to delete reference to Gram Stain Kits and Reagents, as no kits were involved in the recall.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter, on July 9, 2004. Firm initiated recall is ongoing.

PRODUCT: a) AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974. Recall # Z-0032-05. b) AXIOM Sensis Programmable diagnostic comp uter, Model number 66 34 633. Recall # Z-0033-05; c) AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641. Recall # Z-0034-05; d) AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658. Recall # Z-0035-05; e) AXIOM Sensis Programmable diagnostic computer, Model number 66 48 161. Recall # Z-0036-05.

REASON: Possible error calculating valve area with the AXIOM Sensis.

MANUFACTURER: 3 M Company/Medical Division, South St Paul, MN, by letter dated September 30, 2004. Firm initiated recall is ongoing.

PRODUCT: NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V. Recall # Z-0037-05.

REASON: Improper wire placement from the patient plate to the ESU connector plug results in an intermittent displacement connection.

MANUFACTURER: Kinetic Concepts, Inc., San Antonio, TX, by letter and telephone on September 21, 2004. Firm initiated recall is ongoing.

PRODUCT: V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Recall # Z-0038-05.

REASON: The seal on the pouch may open during shipping and sterility may be compromised.

MANUFACTURER: Medrad Inc., Indianola, PA, by telephone on October 8, 2004. Firm initiated recall is ongoing.

PRODUCT: Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT. Recall # Z-0039-05.

REASON: Sterility can be compromised by a component tearing the outer packaging.

MANUFACTURER: Zimmer Spine, Inc., Minneapolis, MN, by letter, and telephone on August 24, 2004. Firm initiated recall is ongoing.

PRODUCT: ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays. Recall # Z-0040-05.

REASON: To date, there has been one complaint reported. During a Trinica surgical case, the surgeon was provided a standard disposable, Trinica Drill Bit (part number 07.00166.001) for use with the Trinica All Through One Drill Guide Instrumentation, instead of the ALL Through One Drill Bit. This enabled the physician to drill a few millimeters further than expected.

MANUFACTURER: Linvatec Corp, Largo, FL, by telephone, email, and letter on August 26, 2004. Firm initiated recall is ongoing.

PRODUCT: Ultra Power Burs, Sterile, Single-Use. Recall # Z-0041-05.

REASON: The pouch containing the sterile product is not completely sealed on all products. Therefore, the sterility of the device is questionable.

MANUFACTURER: Dade Behring, Inc., Newark, DE, by letter dated August 27, 2004. Firm initiated recall is ongoing.

PRODUCT: DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies. Recall # Z-0042-05.

REASON: APTT determinations when using affected rotors may lead to incorrectly shortened times.

MANUFACTURER: BioMerieux, Durham, NC, by letter on June 11, 2004 and July 9, 2004. Firm initiated recall is ongoing.

PRODUCT: The MDA system with MDA Antithrombin III MDA Heparin. Recall # Z-0043-05.

REASON: The firm received complaints regarding an observed bias in percent activity between capped and uncapped specimens.

MANUFACTURER: Advanced Bionics, Sylmar, CA, by telephone and letter on September 27, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R (For Export Only) AB-5100H AB-5100H-01A. Recall # Z-0044-05; b) Advanced Bionics implantable cochlear stimulator CLARION CII Models AB-5100H-11A AB-5100h-12A. Recall # Z-0045-05; c) Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01 CI-1400-02. Recall # Z-0046-05.

REASON: All unimplanted CLARION and HiResolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.

MANUFACTURER: Weck, Research Triangle Park, NC, by letter and email on August 18, 2004. Firm initiated recall is ongoing.

PRODUCT: Hem-o-lok® Endo5™ Ligation Applier. Recall # Z-0031-05.

REASON: The jaws may break during clip loading or clip application.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 27, 2004:

CLASS II

MANUFACTURER: General Electric Med. Systems LLC, Waukesha, WI, by letter dated August 5, 2004. Firm initiated recall is ongoing.

PRODUCT: Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam. Recall # Z-0012-05.

REASON: GE Healthcare received reports of intermittent low ejection fraction (EF) results for MUGA (multi-gated acquisitions) studies on Millennium VG systems. This issue can occasionally lead to distortions in the volume curve in some MUGA studies, and result in calculated EF values lower (never higher) than actual values. A low EF value could lead to a physician decision to stop needed treatment.

MANUFACTURER: Stryker Instruments, Instruments Div., Kalamazoo, MI, by letter and telephone on July 14, 2004. Firm initiated recall is complete.

PRODUCT: a) Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000. Recall # Z-0020-05. b) Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000. Recall # Z-0021-05.

REASON: The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affect the patient tracker system.

MANUFACTURER: Independence Technology LLC, Warren, NJ, by telephone beginning on August 30, 2004, and by letters on August 31, and September 1, 2004. Firm initiated recall is ongoing.

PRODUCT: iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair). Catalog No.'s IT000101-IT000148 (inclusive). Recall # Z-0022-05.

REASON: Rocks and debris can enter into the wheel cluster housing through a damaged wheel cap causing wheel malfunction.

MANUFACTURER: Stryker Medical, Kalamazoo, MI, by visit beginning on August 10, 2004. Firm initiated recall is complete.

PRODUCT: Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092. Recall # Z-0023-05.

REASON: Locking pins may be installed backward, and cot may drop from highest to lowest position when the users are not prepared for the drop.

MANUFACTURER: Becton Dickinson and Co, Sparks, MD, by fax, letter, and e-mail on September 29, 2004. Firm initiated recall is ongoing.

PRODUCT: Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent contained in Becton Dickinson's BD Gram Stain Kits and Reagents, catalog #212539. Recall # Z-0025-05.

REASON: Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on July 15, 2004. Firm initiated recall is ongoing.

PRODUCT: CryoValve, Pulmonary Valve & Conduit. Recall # Z-0026-05.

REASON: A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus.

MANUFACTURER: Ciba Vision Corporation, Duluth, GA, by letter on October 1, 2004. Firm initiated recall is ongoing.

PRODUCT: SOLO-care® Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, Made in Canada, Assembled in Canada, The product is distributed in units of single or twin packs containing 2 to 12 ounces of product. Recall # Z-0028-05.

REASON: Stability tests at 24 months revealed failing results for disinfection efficacy.

MANUFACTURER: Implant Innovations, Inc., Palm Beach Gardens, FL, by e-mail, letter and telephone. Firm initiated recall is ongoing.

PRODUCT: EP Healing Abutment -- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant. Product Code: THA54. Recall # Z-0029-05.

REASON: The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.

MANUFACTURER: General Electric Medical Systems Information Technology, Milwaukee, WI, by letter on October 11, 2004. Firm initiated recall is ongoing

PRODUCT: GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, and 4.0.6. Recall # Z-0030-05.

REASON: The following two conditions may occur with the printing of full disclosure strips and reports, printing of the alarm history events stored on a GE Unity Network Patient Data Server (PDS), and printing of caliper reports in the GE CIC Pro central station monitoring product, 1) a delay or cessation in updating portions of the display screen: or, 2) System reset/restart.

CLASS III

MANUFACTURER: Remel, Inc., Lenexa, KS, by telephone on September 27, 2004. Firm initiated recall is complete.

PRODUCT: Remel Chocolate Agar, catalog # 01301, containing 15 plates/pkg, for in-vitro diagnostic use. Recall # Z-0024-05.

REASON: The product does not perform as intended with some quality control organisms (Haemophilus influenzae).

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 20, 2004:

CLASS II

MANUFACTURER: Zymed Laboratories Inc., South San Francisco, CA, by telephone, visits and fax on April 6, 2004. Firm initiated recall is complete.

PRODUCT: a) Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient. Recall # Z-0014-05; b) Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types of cancer when used to test a patient. Recall # Z-0015-05.

REASON: Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on September 24, 2004. Firm initiated recall is ongoing.

PRODUCT: Aeroset Analyzer Systems Operation Manual. Recall # Z-0016-05.

REASON: Changes to the printer default settings made by users/operators cause printed data to be truncated and misidentified.

MANUFACTURER: Fresenius Medical Care North America, Lexington, MA, by telephone starting September 20, 2004, and by letter on September 27, 2004. Firm initiated recall is ongoing.

PRODUCT: Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8", Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034. Recall # Z-0017-05.

REASON: Peritoneal Dialysis Transfer Set may have occluded pathway.

MANUFACTURER: Datascope Corp., Mahwah, NJ, by letter on September 24, 2004. Firm initiated recall is ongoing.

PRODUCT: Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). Recall # Z-0018-05.

REASON: Software anomaly where the variable heart rates may be displayed inaccurately or intermittent "dashes" may be displayed when the patient's heart rate is derived from ECG.

MANUFACTURER: Health Directions, Inc., Morrisville, PA, by letter dated April 8, 2004. Firm initiated recall is complete.

PRODUCT: HealthPax (HP-1). Cranial Electrotherapy Stimulator GZJ. Recall # Z-0019-05.

REASON: Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 13, 2004:

CLASS II

MANUFACTURER: DeRoyal Wound Care, Rose Hill, VA, by telephone and letter on July 8, 2004 and July 13, 2004. Firm initiated recall is complete.

PRODUCT: Aquasorb Æ Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***. Recall # Z-0001-05.

REASON: Wound dressing failed to meet sterility specifications.

MANUFACTURER: ABX Diagnostics, Inc., Irvine, CA, by letter on August 13, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Automated Differential Cell Counter. Recall # Z-0002-05; b) Automated Differential Cell Counter. Recall # Z-0003-05.

REASON: Device can generate overestimated platelet results

MANUFACTURER: Ameriwater Inc., Dayton, OH, by letter on September 3, 2004. Firm initiated recall is ongoing.

PRODUCT: Ameriwater Portable RO+, model numbers MR01 and MR02. The device is reverse osmosis system for dialysis. Recall # Z-0004-05.

REASON: The device has a potential risk of failure caused by faulty wiring within the electrical component. The wires can overheat and eventually break in two.

MANUFACTURER: Abbott Health Products, Inc., Barceloneta, PR, by letters dated August 24, 2004. Firm initiated recall is ongoing.

PRODUCT: AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21. Recall # Z-0006-05.

REASON: Assay may give elevated patients results.

MANUFACTURER: Ev3, Plymouth, MN, by letter dated September 01, 2004. Firm initiated recall is ongoing.

PRODUCT: Protege GPS Biliary Stent System (6Fr 9mm x 30mm). Recall # Z-0008-05.

REASON: A customer complaint received indicated that a ProtÈgÈ stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The ProtÈgÈ GPS Stent System is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. The pouch seal ensures sterility of the external surface of the inner tray. The inner tray seal containing the device was not affected.

MANUFACTURER: Applied Medical Resources, Corp., Rancho Santa Margarita, CA, by letter on September 16, 2004. Firm initiated recall is ongoing

PRODUCT: Applied Blunt Tip Trocar Models C0717 and C0718. Recall # Z-0009-05

REASON: Inadequate trocar tip assembly that might yield parts to patients

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated July 7, 2004. Firm initiated recall is complete.

PRODUCT: Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205. Recall # Z-0013-05.

REASON: Mislabeled as to size; 1.55 mm pins are labeled as 2mm.

CLASS III

MANUFACTURER: CooperSurgical, Inc., Trumbull, CT, by telephone on August 18, 2004. Firm initiated recall is ongoing.

PRODUCT: Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047. Recall # Z-0005-05.

REASON: Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047. Recall # Z-0005-05.

MANUFACTURER: Dade Behring, Inc., Newark, DE, by letter dated July 21, 2004. Firm initiated recall is ongoing.

PRODUCT: BC Thrombin Reagent. Thrombin Time Test. Recall # Z-0007-05.

REASON: The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients receiving heparin.

MANUFACTURER: Medtronic MiniMed, Northridge, CA, by letter on September 14, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Medtronic MiniMed Paradigm Model 712. Recall # Z-0010-05; b) Medtronic MiniMed Paradigm Model 512. Recall # Z-0011-05.

REASON: Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 6, 2004:

CLASS II

MANUFACTURER: Alveolus, Inc., Charlotte, NC, by telephone on April 22, 2004. Firm initiated recall is ongoing.

PRODUCT: Alveolus Tracheobronchial Stent Technology System (TB-STS). Recall # Z-1487-04.

REASON: The tracheal stent may collapse resulting in blockage of the air passage because the stents were not properly coated with the polyurethane material to the very end of the stent.

MANUFACTURER: Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letter on August 20, 2004. Firm initiated recall is ongoing.

PRODUCT: NT Intera Magnetic Resonance Image System. Recall # Z-1488-04.

REASON: Potential for patient burn.

MANUFACTURER: Medtronic, Inc., Minneapolis, MN, by letter dated September 23, 2004. Firm initiated recall is ongoing

PRODUCT: Medtronic FLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036. Recall # Z-1489-04.

REASON: Spiral tip from DLP VAD cannula may be loose and potentially detach during use.

MANUFACTURER: Deroyal Surgical-Rose Hill, Rose Hill, VA, by letter on September 9, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Impervious Stockinette, Large, 12” X 48” or 12” X 54”, Ref #9806-54, #9816-54, and #9978-12; X-Large, 16” X 48”, Ref #9978-16. Recall # Z-1490-04 b) Stockinette, Single Ply Econo Weave, 8 X 72", Ref #9999-72. Recall # Z-1491-04 c) Stockinette, Single Ply, Standard Weave, 8 X 72” and 10 X 48”, Ref #9508-72, #9510-48, #9510-48, #9510-60. Recall # Z- 1492-04 d) Stockinette, Double Ply, Standard Weave, 6 X 60", 6 X 72", 8 X 48", 8 X 60", 8 X 72", 10 X 48". Recall # Z-1493-04 e) Stockinette, Double Ply, Econo Weave, 6 X 54", 6 X 60", 6 X 72", 8 X 48", 8 X 72", Ref #9984-54, #9984-54, #9985-60, #9986-72, #9987-48, #9988-60, #9988-72. Recall # Z-1494-04 f) Stockinette, Double Ply, Econo Weave, EZ Roll, 6 X 60”, 8 X 60”, Ref#9991-60, #9993-60. Recall # Z-1495-04.

REASON: Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.

MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter on August 27, 2004. Firm initiated recall is ongoing

PRODUCT: Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests; Recall # Z-1498-04.

REASON: There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots.

MANUFACTURER: PerkinElmer LAS Inc., Norton, OH, by letter on September 8, 2004. Firm initiated recall is ongoing.

PRODUCT: Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000. Recall # Z-1499-04.

REASON: The test kits are producing lower values than expected which may result in an increased number of false positive results increasing the risk of missing a baby with galactosemia.

MANUFACTURER: Omrix Biopharmaceuticals, Ltd., Plasma Fract. Inst., Magen David Adom Blood Services Ctr., Ramat Gan, Israel, by letter on July 25, 2004. Firm initiated recall is ongoing.

PRODUCT: Crosseal, fibrin sealant (human), One Applicator, Two Vial cups, Sterile, Disposable, Single Use, Rx Only. Recall # Z-1497-04.

REASON: 5 mL Crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 29, 2004:

CLASS I

MANUFACTURER: Medtronic Inc, Neurological & Spinal Division, Columbia Heights, MN, by letters on August 24, 2004. Firm initiated recall is ongoing.

PRODUCT: 8870 software application card Version AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N'Vision Clinician Program. Recall # Z-1334-04.

REASON: Users may mistakenly enter a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. This issue is limited to programming the SynchroMed and SynchroMed EL pumps.

MANUFACTURER: Pulmonetic Systems, Inc, Minneapolis, MN, by letter on September 7, 2004. Firm initiated recall is ongoing.

PRODUCT: The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for use by personnel under the direction of a physician. The ventilator is suitable for use in institutional, home and transport settings. Recall # Z-1485-04.

REASON: LTV Series of Ventilators (Models 1000, 950, 900 and 800). The ventilator has not consistently switched to internal battery operation when the external DC power source has become inadequate to supply stable power, resulting in loss of ventilation to the patient.

*****CORRECTION***** In the September 22, 2004 Enforcement Report 04-38, Recall # Z-1458/71-04, the CODE information has been amended from "All lots" to "Lot numbers ending in the letters "S" or "T".

CLASS II

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on June 16, 2004. Firm initiated recall is ongoing.

PRODUCT: a) ACOM.M angiographic x-ray system. Model number 4371741. Recall # Z-1477-04; b) ACOM.M angiographic x-ray system. Model number 5215707. Recall # Z-1478-04.

REASON: Possible problem reviewing images on the ACOM.M.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letters dated August 24, 2004. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom brand VersaCare Bed; Model P3200. Recall # Z-1482-04

REASON: Pivot bolts on the sleep deck may become loose and fall out, allowing the head section to shift or to drop to one side, and a grounding warning label is missing.

MANUFACTURER: Datascope Corp., Mahwah, NJ, by letter on July 28, 2004. Firm initiated recall is ongoing.

PRODUCT: Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). Recall # Z-1483-04.

REASON: The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.

MANUFACTURER: CryoLife, Inc., Kennesaw, GA, by telephone on April 12, 2004. Firm initiated recall is complete.

PRODUCT: CryoValve, Conduit and Pulmonary Valve and Conduit. Donor #66949. Model #SGPV00. Recall # Z-1484-04.

REASON: CryoLife received information regarding a positive culture for Group A Streptococcus infection in a recipient of tissue procured from the attached donor.

CLASS III

MANUFACTURER: Advanced Sterilization Products, Irvine, CA, by e-mail letter on September 4, 2003. Product alert was issued on all test strips sold in US dated September 24 and October 3, 2003. Foreign affiliates sent letters dated September 4, 5, 11, 19, & 24, 2003. Firm initiated recall is complete.

PRODUCT: a) Gluteraldehyde Concentration Indicators "Browne GA Indicator for CIDEX PLUS Products. Recall # Z-1479-04; b) Gluteraldehyde Concentration Indicators "Browne GA Indicator for CIDEX Products. Recall # Z-1480-04; c) Orthophthaladehyde Concentration Indicator Browne CIDEX OPA Indicator. Recall # Z-1481-04.

REASON: Performance failure complaints, moisture ingress into the bottles was causing failure or variability in results.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 22, 2004:

CLASS II

MANUFACTURER: Nipro Diabetes Systems, Inc, Miramar, FL, by letter and/or telephone on May 7, 2004. Firm initiated recall is complete.

PRODUCT: Amigo Insulin Infusion Pump. Model #s 990001, 990002, 990003, 990004, 990005, and 990006. Recall # Z-1335-04.

REASON: A FDA inspection of the firm revealed deficiencies in the company’s quality system. Problems exhibited may include motor failure or unintended operation.

MANUFACTURER: B. Braun Medical, Inc., Allentown, PA, by letter dated July 8, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Standard and Custom Spinal Trays with 5% Lidocaine Hydrochloride 2 ml ampul. Recall # Z-1439-04; b) Standard and Custom Spinal Trays with 7.5% Dextrose Injection USP 2 ml ampul. Recall # Z-1440-04.

REASON: Drug ampuls in kits contain particulates.

MANUFACTURER: Datascope Corp., Mahwah, NJ, by a Field Correction action initiated in June, 2003 and completed by the service reps in April 2004. Firm initiated recall is complete.

PRODUCT: Anestar Anesthesia Delivery System. Recall # Z-1441-04.

REASON: Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by a Customer Safety Advisory on May 17, 2004. Firm initiated recall is ongoing.

PRODUCT: Axiom Sensis Report Workstation. Recall # Z-1446-04.

REASON: Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.

MANUFACTURER: Zimmer Inc., Warsaw, IN, by letter dated August 3, 2004 and a dear doctor letter dated August 25, 2004. Firm initiated recall is complete.

PRODUCT: a) Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 2, sterile, for cemented use only; Cat. No. 5880-02-02. Recall # Z-1447-04; b) Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat No. 5880-03-02. Recall # Z-1448-04.

REASON: The polyethylene tibial bushing was omitted from the taper of the tibial plates.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on August 12, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Axiom Artis BA or BC Biplane System, Angiographic x-ray system. Model number 59 04 649. Recall # Z-1449-04; b) Axiom Artis BA or BC Biplane System, Angiographic x-ray system. Model number 59 04 656. Recall # Z-1450-04.

REASON: Opacification Function of device may incorrectly merge images.

MANUFACTURER: Dana Diabecare USA LLC, New Orleans, LA, by email, letters and telephone on May 26, 2004. Firm initiated recall is ongoing.

PRODUCT: DANA Diabecare II insulin pumps. Recall # Z-1451-04.

REASON: There is a switch malfunction that may cause the unit not to respond when command key is depressed.

MANUFACTURER: Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letter dated July 19, 2004. Firm initiated recall is ongoing.

PRODUCT: a) BV25 Mobile X-Ray System. Recall # Z-1453-04; b) BV25 Gold Mobile X-Ray System. Recall # Z-1454-04; c) BV26 Mobile X-Ray System. Recall # Z-1455-04; d) BV29 Mobile X-Ray System. Recall # Z-1456-04; e) BV212 Mobile X-Ray System. Recall # Z-1457-04;

REASON: Potential for c-arm to move due to loose screws.

MANUFACTURER: Premier Dental Products Co., Plymouth Meeting, PA, by letters dated August 5, 2004 and August 11, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Jackson Original Stainless Steel Tracheostomy Tubes, several item numbers and sizes. Recall # Z-1458-04; b) Jackson Original Short Stainless Steel Tracheostomy Tubes, several item numbers and sizes. Recall # Z-1459-04; c) Jackson Improved Stainless Steel Tracheostomy Tubes, several item numbers and sizes. Recall # Z-1460-04; d) Jackson Improved Short Stainless Steel Tracheostomy Tubes, several item numbers and sizes. Recall # Z-1461-04; e) Jackson Improved Short Stainless Steel Tracheostomy Tubes, several item numbers and sizes. Recall # Z-1462-04; f) Jackson Improved Short Stainless Steel with Adapter Tracheostomy Tubes, several item numbers and sizes. Recall # Z-1463-04; g) Jackson Improved Extra Long Stainless Steel Tracheostomy Tubes, several item numbers and sizes. Recall # Z-1464-04; h) Air Lon Nylon, Tracheostomy Tubes, item numbers and sizes. Recall # Z-1465-04; i) Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, Tracheostomy Tubes, several item numbers and sizes. Recall # Z-1466-04; j) Laryngectomy Tubes, Martin Stainless Steel, item number 1036128 size 8 and item number 1036130 size10. Recall # Z-1467-04; k) Jackson Original Stainless Steel Laryngectomy Tubes, several item numbers and sizes. Recall # Z-1468-04; l) Laryngectomy Tubes, Jackson Improved Stainless Steel, several item numbers and sizes. Recall # Z-1469-04; m) Air Lon Nylon Laryngectomy Tubes, item number1050170 size 8 and item number 1050172 size 10. Recall # Z-1470-04; n) Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon Laryngectomy Tubes, item number 1050200 size 8 and item number 1050202 size 10. Recall # Z-1471-04.

REASON: Foreign objects (polishing stones) in the tubes.

MANUFACTURER: Zoll Medical Corp., Chelmsford, MA, by letter on August 2, 2004. Firm initiated recall is ongoing.

PRODUCT: Zoll M Series Automated Defibrillator (AED). Recall # Z-1472-04.

REASON: Visual Screen display and audible prompt may not advise to “Press Shock”.

MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letters dated September 1, 2004. Firm initiated recall is ongoing.

PRODUCT: XSYSTEMS Dilution Buffer, list number 9519-02, for In Vitro diagnostic use, Bovine gamma globulin in Phosphate buffer, with Siduyn Azude as a oreservatuvem 950 mL bottle, 4 bottles per carton. Recall # Z-1474-04.

REASON: The XSYSTEMS Dilution Buffer when used with TDx/TDxFLx Benzodiazepines assay can cause shifts in control values and patient results.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated June 7, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Siregraph CF X-Ray System. Fluoroscopic image intensified. Model number 4466033. Recall # Z-1475-04; b) Siregraph CF X-Ray System. Fluoroscopic image intensified. Model number 4466041. Recall # Z-1476-04.

REASON: Unintended X-ray tube movement when table is tilted more than 90 degrees.

CLASS III

MANUFACTURER: Remel, Inc., Lenexa KS, by letter on July 15, 2002. Firm initiated recall is complete.

PRODUCT: ProSpecT Campylobacter Microplate Assay. Catalog #2476096. Recall # Z-1372-04.

REASON: A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged

MANUFACTURER: Boston Scientific Corp., Natick, MA, by letters dated August 9, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Manual Biopsy Devices containing AIM system: Chiba Needle, 6 inch/15 cm, 22 gauge, Catalog #40-102, Material #M001401021 (10 per box).Recall # Z-1442-04; b) Manual Biopsy Devices containing AIM system: Chiba Needle, 8 inch/20 cm, 22 gauge, Cat. #40-103, Material #M001401031 (10 per box). Recall # Z-1443-04; c) Manual Biopsy Devices containing AIM system: Crown Biopsy Needle: 6 inch/15 cm, 22 gauge, Cat. #40-404, Material #M001404041 (10 per box). Recall # Z-1444-04; d) Manual Biopsy Devices containing AIM system: Co-Axial Lung Biopsy Needle, 6 inch/15 cm, 22 gauge, Cat. #40-600, Material #M001406001 (5 per box).Recall # Z-1445-04.

REASON: Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.

MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter on August 19, 2004. Firm initiated recall is ongoing.

PRODUCT: ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests). Recall # Z-1452-04.

REASON: Changes in the ARCHITECT B12 Reagent lots may adversely affect the shape of the calibration curve, over time. These changes may produce controls out of range low and similar decreases in patient sample values prior to current expiration of the reagents.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 15, 2004:

CLASS I

MANUFACTURER: Nellcor Puritan Bennett, Pleasanton, CA, by letters on August 24, 2004, telephone on August 25, 2004, and by press release on August 27, 2004. Firm initiated recall is ongoing.

PRODUCT: The probes involved have been part of the NellcorÆ CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each probe is packaged in a metal canister filled with a nonsterile buffered saline solution. The canister is in a sealed foil envelope. Each disposable probe is used only one time. Recall #Z-1414-04.

REASON: The product is contaminated with Burkholderia cepacia (formally known as Pseudomonas cepacia), based on the Texas Health Department analysis and also firm's analysis.

CLASS II

MANUFACTURER: Celsion Corporation, Columbia, MD, by visit on June 25, 2004 and letter on July 19, 2004. Firm initiated recall is ongoing.

PRODUCT: Prolieve? Thermodilatation System, Model number M0068808000. Recall # Z-1339-04.

REASON: Software controlling a medical device for patient treatment may malfunction and cause thermal injury to patient.

MANUFACTURER: Spinal Concepts, Inc., Austin, TX, by telephone on April 1, 2004. Firm initiated recall is complete.

PRODUCT: Harmony MIS Life Instruments, Lumbar Spacer Systems. Part numbers 2851-1-01, 2851-1-30, 2851-2-01, 2851-2-30, 2851-3-01, 2851-3-30, 2851-4-01, 2851-4-30, 2851-4-31, 2851-5-01, 2851-5-30, 2852-2, 2852-4, 2854-1, 2857-1, 2857-2, 2858-1, 2859-1, 2861-5, and 2862-1. Recall # Z-1343-04.

REASON: Handle becomes loose after repeated use.

MANUFACTURER: Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letters on July 7, and July 29, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Sarns brand Retrograde Cardioplegia Cannulae, manual‚ inflate, 17 Fr, guidewire stylet, ribbed balloon; catalog number 4427. Recall # Z-1345-04; b) Sarns brand Retrograde Cardioplegia Cannulae, manual‚ inflate, 17 Fr, steerable stylet, ribbed balloon; catalog number 4428. Recall # Z-1346-04; c) Sarns brand Retrograde Cardioplegia Cannulae, manual‚ inflate, 17 Fr, malleable stylet, ribbed balloon; catalog number 4429. Recall # Z-1347-04; d) Sarns brand Retrograde Cardioplegia Cannulae, manual‚ inflate, 17 Fr, malleable stylet, ribbed balloon; catalog number 4430. Recall # Z-1348-04; e) Sarns brand Retrograde Cardioplegia Cannulae, manual‚ inflate, 13 Fr, steerable stylet, ribbed balloon; catalog number 5578. Recall # Z-1349-04; f) Sarns brand Retrograde Cardioplegia Cannulae, manual‚ inflate, 13 Fr, malleable stylet, ribbed balloon; catalog number 5579. Recall # Z-1350-04; g) Sarns brand Retrograde Cardioplegia Cannulae, manual‚ inflate, 13 Fr, guidewire stylet, ribbed balloon; catalog number 5580. Recall # Z-1351-04; h) Sarns brand Retrograde Cardioplegia Cannulae, auto‚ inflate, 13 Fr, malleable stylet, ribbed balloon, extended length, 14" (35 cm) long; catalog number 5584. Recall # Z-1352-04; i) Sarns brand Retrograde Cardioplegia Cannulae, auto‚ inflate, 13 Fr, steerable stylet, ribbed balloon, extended length, 14" (35 cm) long; catalog number 5585. Recall # Z-1353-04; j) Sarns brand Retrograde Cardioplegia Cannulae, auto‚ inflate, 13 Fr, rigid stylet, ribbed balloon, standard length, 12" (30.5 cm) long; catalog number 5586. Recall # Z-1354-04; k) Sarns brand Retrograde Cardioplegia Cannulae, auto‚ inflate, 13 Fr, rigid stylet, ribbed balloon, extended length, 14" (35 cm) long; catalog number 5587. Recall # Z-1355-04; l) Sarns brand Retrograde Cardioplegia Cannulae, manual‚ inflate, 15 Fr, guidewire stylet, smooth balloon; catalog number 7270. Recall # Z-1356-04; m) Sarns brand Retrograde Cardioplegia Cannulae, manual‚ inflate, 15 Fr, steerable stylet, smooth balloon; catalog number 7271. Recall # Z-1357-04; n) Sarns brand Retrograde Cardioplegia Cannulae, manual‚ inflate, 15 Fr, guidewire stylet, ribbed balloon; catalog number 7272. Recall # Z-1358-04; o) Sarns brand Retrograde Cardioplegia Cannulae, manual‚ inflate, 15 Fr, steerable stylet, ribbed balloon; catalog number 7273. Recall # Z-1359-04.

REASON: The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.

MANUFACTURER: Roche Molecular Systems, Inc., Belleville, NJ, by letters on June 24, 2004 and July 6, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Amplicor (3) AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor CT/NG CT Detection Kit. Recall # Z-1360-04; b) Amplicor (3) AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor CT/NG NG Detection Kit. Recall # Z-1361-04; c) Amplicor (3) AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor HCV Detection Kit, v2.0. Recall # Z-1362-04; d) Amplicor (3) AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor HCV Detection Kit, 96 test. Recall # Z-1363-04; e) Amplicor (3) AV-HRP. Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AmpliCap HCV Monitor Test, Export, RUO. Recall # Z-1364-04; f) Amplicor (3) AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: Amplicor IC Detection Kit, Export, IVD/CE. Recall # Z-1365-04; g) Amplicor (3) AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: Amplicor M. avium Detection Kit, Export, RUO. Recall # Z-1366-04; h) Amplicor (3) AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: Amplicor MTB Detection Kit, Gen 2 Export, IVD/CE. Recall # Z-1367-04; i) Amplicor (3) AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: Amplicor NG Detection Kit, Export, IVD/CE. Recall # Z-1368-04.

REASON: An increased frequency of "blue foci" that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.

MANUFACTURER: Roche Diagnostics Corp, Indianapolis, IN, by letter dated August 6, 2004. Firm initiated recall is ongoing.

PRODUCT: MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Recall # Z-1371-04.

REASON: A hardware/software problem will result in low elution volumes and bias sample results for various protocols.

MANUFACTURER: Abbott Laboratories Diagnostic Div., South Pasadena, CA, by letters on July 27, 2004. Firm initiated recall is ongoing.

PRODUCT: Abbott Clinical Chemistry AEROSET/ARCHITECT c8000 Creatinine. List No. 7D64-20. Recall # Z-1377-04.

REASON: Precipitate formed in product.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter sent July 29, 2004. Firm initiated recall is ongoing.

PRODUCT: SYNCHRON Clinical Systems Enzyme Validator Kit. Recall # Z-1378-04.

REASON: Incorrect Calibration Acceptance Limits.

MANUFACTURER: Bock, Otto, Orthopedic Ind., Inc., Minneapolis, MN, by telephone on July 15, 2004. Firm initiated recall is ongoing.

PRODUCT: Otto Bock 3R90 and 3R92 Modular Knee Joint with Friction Brake. Recall # Z-1379-04.

REASON: Braking Plates of the 3R90 and 3R92 Modular Knee Joint with Friction Brake may become dislodged which may cause the breaking performance of the knee to malfunction

MANUFACTURER: Bio-Detek, Inc., Pawtucket, RI, by letter dated July 28, 2004. Firm initiated recall is ongoing.

PRODUCT: Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part number: 8900-2065. Recall # Z-1380-04.

REASON: Pads may fail due to excessive corrosion of the electrode prior to the expiration date.

MANUFACTURER: TissueLink Medical, Inc., Dover, NH, by visit on July 22, 2004. Firm initiated recall is ongoing.

PRODUCT: a) ADP2.1 Adapter, non-sterile reusable Model Number: 30-802-1, an accessory used with the TissueLink BiPolar Floating Device. Recall # Z-1415-04; b) ADP 3.2 Adapter, non sterile reusable Model Number: 30-801-1, an accessory used with the TissueLink Bipolar Floating Device. Recall # Z-1416-04.

REASON: Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.

MANUFACTURER: Duro-Med Industries, Inc., Jesup, GA, by letters dated August 4, 2004 and August 18, 2004. Firm initiated recall is ongoing.

- 6 - PRODUCT: a) Allegiance Laminated Wood Crutches, item 74151-010, Large Adult ‚ 51" ‚ 64"; 1 pair individually shrink wrapped, 10 pairs per case; catalog #74151-010, all product labeled Made in China. Recall # Z-1417-04; b) Allegiance Laminated Wood Crutches, item 74151-020, Adult ‚ 47" ‚ 57"; 1 pair individually shrink wrapped, 10 pairs per case; catalog #74151-020, all PRODUCT labeled, Made in China. Recall # Z-1418-04; c) Allegiance Laminated Wood Crutches, item 74151-030, Medium ‚ 43" ‚ 53"; 1 pair individually shrink wrapped, 10 pairs per case; catalog #74151-030, all PRODUCT labeled Made in China. Recall # Z-1419-04; d) Allegiance Laminated Wood Crutches, item 74151-040, Youth ‚ 35" ‚ 43"; 1 pair individually shrink wrapped, 10 pairs per case; Made in China, catalog #74151-040. Recall # Z-1420-04; e) Allegiance Laminated Wood Crutches, item 74151-050, Child ‚ 28" ‚ 36"; 1 pair individually shrink wrapped, 10 pairs per case; Made in China, catalog #74151-050. Recall # Z-1421-04.

REASON: The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches.

MANUFACTURER: St. Jude Medical/Daig Division, Minnetonka, MN, by visit and letters starting August 4, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Right Superior Reorder #407900. The product is packaged in an open, semi-rigid plastic tray, which is then placed in a sterile barrier pouch consisting of Tyvek on one side and a clear plastic film on the other. This pouch is then heat sealed prior to sterilization. Recall # Z-1425-04; b) Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Left Lateral Reorder #407901. The product is packaged in an open, semi-rigid plastic tray, which is then placed in a sterile barrier pouch consisting of Tyvek on one side and a clear plastic film on the other. This pouch is then heat sealed prior to sterilization. Recall # Z-1426-04.

REASON: St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inventory at St. Jude Medical indicated that the side arm from the inner sheath can detach during routine handling and manipulation, and occurs on a random basis.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letters dated August 6, 2004.Firm initiated recall is ongoing.

PRODUCT: a) Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680. Recall # Z-1428-04; b) Roche/Hitachi Modular Analytical D Module clinical chemistry analyzer; catalog number 03739023001. Recall # Z-1429-04; c) Roche/Hitachi Modular Analytical D Module DAT clinical chemistry analyzer; catalog number 04429338160. Recall # Z-1430-04; d) Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number 04429389160. Recall # Z-1431-04; e) Roche/Hitachi 747 - 200 clinical chemistry analyzer; catalog number 04009223680. Recall # Z-1432-04.

REASON: A software defect will allow the reporting out of believable, but clinically significant, erroneous results if the analyzer is in operation and a channel has been masked or not requested over a period of time.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter, dated August 12, 2004. Firm initiated recall is ongoing.

PRODUCT: COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH %500 Analyzer also provides a semi-automated reticulocyte analysis. Recall # Z-1433-04.

REASON: Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit, and/or print an erroneous result or an incorrect dilution factor with a predilute sample result.

MANUFACTURER: Abbott Health Products, Inc., Barceloneta, PR, by letters dated July 7, 2004. Firm initiated recall is ongoing.

PRODUCT: AxSYM Total B-hCG Reagent Pack. Recall # Z-1436-4.

REASON: For failing calibrations.

MANUFACTURER: Biosense Webster, Inc, Irwindale, CA, by letter on August 16, 2004. Firm initiated recall is ongoing.

PRODUCT: Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 107835S SW1078-035; D-1078-63-S D5S06AL252RT 36A-07Q; D-1078-78-S 107878S N/A; D-1097-511-S 1097511S SW1097-511; D-1097-554-S D708DL002RT 36F-32Q. Recall # Z-1437-04.

REASON: Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire.

MANUFACTURER: U&I America, Murray, UT, by letter on August 10, 2004. Firm initiated recall is ongoing.

PRODUCT: Optima Spinal System and Spinal Hook System, set screw component. Part number SP3020 (revision 6). Recall # Z-1438-04.

REASON: Threads on a set screw, as a component of a spinal fixation system, may break off during use.

CLASS III

MANUFACTURER: Becton Dickinson & Co., Sparks, MD, by facsimile on July 2, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Sheep Blood, Defibrinated ‚ Catalog Number 211946, Unit 100 ml. Recall # Z-1316-04; b) Sheep Blood, Defibrinated ‚ Catalog Number 212391, Unit 250 Recall # Z-1317-04; c) Sheep Blood, Defibrinated ‚ Catalog Number 212389, Unit 30 Recall # Z-1318-04; d) Sheep Blood, Defibrinated ‚ Catalog Number 211947, Unit 500 Recall # Z-1319-04; e) Sheep Blood, Defibrinated ‚ Catalog Number 211945, Unit 15 Recall # Z-1320-04; f) Sheep Blood, Defibrinated ‚ Catalog Number 212390, Unit 100 ml. Recall # Z-1321-04; g) BBL Brain Heart Infusion Agar w/10% Sheep Blood ‚ Catalog Number 297655. Recall # Z-1322-04; h) BBL TSA II w/5% Sheep Blood, Spacesaver ‚ Catalog Number 292537. Recall # Z-1323-04; i) BBL Columbia C.N.A. Agar w/5% Sheep Blood/Levine EMB ‚ Catalog Number 295618. Recall # Z-1324-04; j) BBL Brain Heart Infusion Agar CC w/ Sheep Blood ‚ Catalog Number 296178. Recall # Z-1325-04; k) BBL Columbia C.N.A. Agar w/5% Sheep Blood, ‚ Catalog Number 297831. Recall # Z-1326-04.

REASON: Sheep Blood products may be contaminated with a Brucella species (B. ovis).

MANUFACTURER: Depuy Orthopaedics, Inc., Warsaw, IN, by verbal contact on December 23, 2003. Firm initiated recall is complete.

PRODUCT: a) P.F.C. ® -- Knee System 7ƒ Fluted Femoral Stem 18mmX125mm REF 96-1703. Recall # Z-1369-04; b) P.F.C. ® -- Knee System 7ƒ Fluted Femoral Stem 18mmX130mm REF: 96-1731. Recall # Z-1370-04.

REASON: The collar was incorrectly etched for the R (Right) and L (Left) orientation

MANUFACTURER: Remel, Inc., Lenexa, KS, by letter on July 15, 2002. Firm initiated recall is complete

PRODUCT: ProSpecT Campylobacter Microplate Assay. Catalog #2476096. Recall # Z-1372-04.

REASON: A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.

MANUFACTURER: Remel, Inc., Lenexa, KS, by letter on July 18, 2002. Firm initiated recall is complete.

PRODUCT: ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay. Catalog # 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX2) in aqueous extracts of fecal specimens and fecal enriched broth cultures. Recall # Z-1373-04.

REASON: A potential contamination was noted and the particulate in the conjugate may cause the dropper tip to become plugged.

MANUFACTURER: Remel, Inc., Lenexa, KS, by letter on November 21, 2002. Firm initiated recall is complete

PRODUCT: ProSpecT Giardia Cryptosporidium Microplate Assay. Catalog # 2458496. Recall # Z-1374-04.

REASON: The conjugate may have become contaminated during filing. The particulates in the contamination may cause the dropper tips to become plugged.

MANUFACTURER: Remel, Inc., Len