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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., Lenexa, KS, by letter on December 10, 2002. Firm initiated recall is complete

PRODUCT: ProSpecT Giardia Cryptosporidium Microplate Assay. Catalog # 2458496. Recall # Z-1375-04.

REASON: The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.

MANUFACTURER: Remel, Inc, Lenexa, KS, by letter on May 16, 2002. Firm initiated recall is complete.

PRODUCT: ProSpecT Cryptosporidium Microplate Assay. Catalog # 2454096. Recall # Z-1376-04.

REASON: The Positive Control may NOT perform as intended through its expiration date and may invalidate an otherwise acceptable run.

MANUFACTURER: Depuy Orthopaedics, Inc., Warsaw, IN, by verbal contact on January 15, 2004. Firm initiated recall is complete.

PRODUCT: P.F.C.Æ Modular Knee System Modular Plus Tibial Wedge 10ƒ HEMI x 8.5MM HEIGHT Product Code: 86-0178. Recall # Z-1382-04.

REASON: Screw size included in system was incorrect.

MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, by letters dated August 20, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1877470 (11877470216). Recall # Z-1434-04; b) Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1928511 (11928511216). Recall # Z-1435-04.

REASON: Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 8, 2004:

CLASS I

MANUFACTURER: Medibo N.V., Hanmont, Achel, Belgium, by letters dated August 6, 2004. Firm initiated recall is ongoing.

PRODUCT: Minerva Patient Lift, model ML-20; this lift has a passive lifting unit. Recall # Z-1381-04.

REASON: The hanger bar may detach from the jib yoke, the M8 bolt in the foot pedal assembly may come loose, and some units may have faulty actuator brackets on the mast assembly, resulting in the patient lift becoming unstable and allowing the patient to fall.

CLASS II

MANUFACTURER: Medstone International, Inc., Aliso Viejo, CA, by letter on June 11, 2004. Firm initiated recall is complete.

PRODUCT: STS-T Mobile x-ray system used with the STS-T lithotripter. Model STS-T. Recall # Z-0884-04.

REASON: Units are defective in that the identification and certification labels were inadequate or missing. The beam limiting device was not appropriate for general purpose radiographic procedures and the beam limiting device could collimate down to 125 square centimeters or less as required.

MANUFACTURER: Independence Technology LLC, Warren, NJ, by telephone on July 2, 3, & 4, 2004 and by letters from July 5, 6, & 8, 2004. Firm initiated recall is ongoing.

PRODUCT: iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device. The device is shipped one each per wooden pallet with wooden sides and top retained by reusable bands. Recall # Z-1383-04.

REASON: IBOT Mobility System may tip over due to malfunction in power base.

MANUFACTURER: Medtronic Inc., Neurological & Spinal Division, Columbia Heights, MN, by letter on July 23, 2004. Firm initiated recall is ongoing.

PRODUCT: The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic(R) implantable programmable infusion pumps (except Medtronic MiniMed pumps). The Model 8540 Catheter Access Port Kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump, infusion, implanted, programmable under product code LKK. Recall # Z-1384-04.

REASON: The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 Catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of product: CS0293.

MANUFACTURER: Weck, NC, by letter beginning October 24, 2003. Form initiated recall is complete.

PRODUCT: a) Weck Hemoclip Traditional Ligating Clips, Ref No. 523170 Hemoclip, 15 Large Tantalum Clips/Cartridge and Ref. No. 523370 Hemoclip 10 Large Tantalum Clips/Cartridge. Recall # Z-1385-04; b) Weck Atrauclip Ligating Clips, Ref. No. 121505 Atrauclip, 15 Large Titanium Clips/Cartridge and Ref. No. 121506 Atrauclip, 10 Large Titanium Clips/Cartridge. Recall # Z-1386-04; c) Weck Hemoclip Traditional Ligating Clips, Ref. No. 523770 Hemoclip, 15 Large Titanium Clips/Cartridge, and Ref. No. 523870 Hemoclip 10 Large Titanium Clips/Cartridge. Recall # Z-1387-04; d) Weck Hemoclip Traditional Ligating Clips, Ref. No. 523171 Hemoclip, 10 Large Tantalum Clips/Cartridge (Non- Sterile) and Ref. No. 523371 Hemoclip, 15 Large Tantalum Clips/Cartridge (Non-Sterile). Recall # Z-1388-04; e) Weck Hemoclip Traditional Ligating Clips, Ref. No. 523771 - Hemoclip, 15 Large Titanium Clips/Cartridge (Non-Sterile) and Ref. No. 523871- Hemoclip, 10 Large Titanium Clips/Cartridge (Non-Sterile). Recall # Z-1389-04; f) Weck Hemoclip Traditional Ligating Clips, Ref No. 523470 Hemoclip, 15 Large Stainless Steel Clips/Cartridge and Ref. No. 523670 Hemoclip, 10 Large Stainless Steel Clips/Cartridge. Recall # Z-1390-04; g) Weck Hemoclip Plus Ligating Clips, Ref. No. 533702 Hemoclip Plus, 25 Medium Titanium Clips, No Tape; Ref. No. 533737 Hemoclip Plus, 25 Small Titanium Clips/Cartridge, No Tape and Ref. No. 533872 Hemoclip Plus, 10 Large Titanium Clips/Cartridge, No Tape. Recall # Z-1391-04; h) Weck Hemoclip Plus Ligating Clips, Ref. No. 533735 and 534735 Hemoclip Plus, 25 Small Titanium Clips, Cartridge; Ref. No. 533870 Hemoclip Plus, 10 Large Titanium Clips/Cartridge and Ref. No. 533700 Hemoclip Plus, 25 Medium Titanium Clips/Cartridge. Recall # Z-1392-04.

REASON: Hole in the sterile unit blister pack that could compromise sterility.

MANUFACTURER: General Electric Med Systems, Waukesha, WI, by Field Modification Instruction beginning on March 23, 2004. Firm initiated recall is ongoing.

PRODUCT: a) SMV FX-40 Nuclear Camera. Recall # Z-1393-04; b) SMV FX-80 Nuclear Camera. Recall # Z-1394-04.

REASON: The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector's radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become loose, fail, or back out.

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

PRODUCT: a) Magnetom Avanto MRI System, Model 7391167. Recall # Z-1395-04; b) Magnetom Harmony MRI System Model number 7106714. Recall # Z-1396-04; c) Magnetom Harmony MRI System Model number 5751438, Recall # Z-1397-04; d) Magnetom Symphony MRI System, Model 7106557. Recall # Z-1398-04; e) Magnetom Symphony MRI System, Model 7104594. Recall # Z-1399-04; f) Magnetom Sonata MRI System, Model 7388148. Recall # Z-1400-04; g) Magnetom Sonata MRI System, Model 7104719. Recall # Z-1401-04; h) Magnetom Sonata MRI System, Model 7106425. Recall # Z-1402-04; i) Magnetom Trio MRI System, Model 7106441. Recall # Z-1403-04; j) Magnetom Trio MRI System, Model 7387074. Recall # Z-1404-4.

REASON: An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows.

MANUFACTURER: Wright Medical Technology, Inc, Arlington, TN, by letter dated July 14, 2004. Firm initiated recall is ongoing.

PRODUCT: Guardian’ Distal Femur Axial Pin. Recall # Z-1405-04.

REASON: Potential for self-locking axial pin to dislodge and ìback outî.

MANUFACTURER: Cardinal Health, McGaw Park, IL, by telephone and letters on July 28, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Jackson-Pratt Hemaduct, 15 Fr round, full duct silicone wound drain; a sterile, single use only, Rx device, individually packaged, 10 drains per box, 8 boxes per case; catalog #JP-HUR880; catalog #JP-HUR880, Recall # Z-1406-04; b) Jackson-Pratt Reservoir, 400 mL suction reservoir; a sterile, single use only, Rx device used as a component of the wound drain system, individually packaged, 10 reservoirs per case, catalog #SU130-1000; Recall # Z-1407-04.

REASON: The products labeled as sterile are not sterile.

MANUFACTURER: Arrow International Inc., Reading, PA, by letter on August 9, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Peritoneal Lavage Kits, Model number AK-09000. Recall # Z-1408-04; b) Peritoneal Lavage Kits, Model number AK-09001. Recall # Z-1409-04.

REASON: Wrong introducer needle in some kits.

MANUFACTURER: Wilson-Cook Medical Inc., Winston-Salem, NC, by visit on January 30, 2003. Firm initiated recall is complete.

PRODUCT: Esophageal Z-StentÆ Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable - Single Use Only, Rx Only, Sterile EO, Order Number EZSP-25-10-FC. Recall # Z-1410-04.

REASON: Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letters dated July 12, and July 15, 2004. Firm initiated recall is ongoing.

PRODUCT: Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026. Recall # Z-1411-04.

REASON: The cautery cover cap may become dislodged during shipping or handling, the cautery switch may be activated and the cautery may melt or burn through the packaging pouch.

MANUFACTURER: ConMed Corporation, Utica, NY, by letters dated August 9, 2004. Firm initiated recall is ongoing

PRODUCT: a) ConMed Stealth Coated Laparoscopic Electrodes with 3/32î pin (60-5158 series) as follows: Cat. #60-5158-027 Spatula 5 mm x 27 cm; Cat #60-5158-032 - Spatula 5 mm x 32 cm; Cat. #60-5158-044 - Spatula 5 mm x 44 cm; Cat #60-5158-127 - L Hook 5 mm x 27 cm; Cat #60-5158-132 - L Hook, 5 mm x 32 cm; Cat #60-5158-144 - L Hook 5 mm x 44 cm; Cat #60-5158-232 - J Hook 5mm x 32 cm; Cat. #60-5158-244 - J Hook 5mm x 44 cm; Cat #60-5158-927 - Needle 5 mm x 27 cm; Cat #60-5158-932 - Needle 5 mm x 32 cm; Recall # Z-1412-04; b) ConMed Stealth Coated Laparoscopic Electrodes with 4mm pin (60-5158 series) as follows: Cat. #60-5158-034 ‚ Spatula, 5 mm x 32 cm; Cat #60-5158-432 ‚ ìLî Hook 5 mm x 32 cm; Cat #60-5158-934 - Needle 5mm x 32 cm. Recall # Z-1413-04.

REASON: Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 25, 2004:

CLASS II

MANUFACTURER: Lorad, A Division of Hologic, Danbury, CT, by letter dated January 14, 2004. Firm initiated recall is complete.

PRODUCT: a) Lorad M-IV Mammography System. Recall # Z-0148-04; b) Lorad M-IV Platinum Mammography System. Recall # Z-0149-04.

REASON: System failed to meet the mA's accuracy specifications at low mA's values.

MANUFACTURER: Boehringer Laboratories, Inc., Norristown, PA, by telephone on May 19, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Boheringer Suction Regulator Model 7702L. Recall # Z-1231-04; b) Boehringer Replacement Gauge Model 9071. Recall # Z-1232-04.

REASON: The suction regulator incorporates a gauge for the verification of suction levels. The particular lot of gauges used in the production of the regulators exhibits a potential to develop a leak and cause the delivered suction to be inaccurate.

MANUFACTURER: Daavlin Distributing Co., Bryan, OH, by service representative visit beginning on September 1, 2003. Firm initiated recall is ongoing.

PRODUCT: a) 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #PASNBSM-2424. Recall # Z-1233-04;

b) 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #ASNBSM-2424. Recall # Z-1234-04; c) 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #LNBH-0048. Recall # Z-1235-04; d) 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #SNBSM-0048. Recall # Z-1236-04; e) 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #ANBSM-0048. Recall # Z-1237-04.

REASON: Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved.

MANUFACTURER: Trays contain Hospira recalled, 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK).

PRODUCT: a) Smiths Medical ASD, Inc, Regional Anesthesia Trays containing the Hospira 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK) as follows: Product Number/Description 15248C-22/25 SPINAL TRAY 22/25 (SDD) W/DRUGS. Recall # Z-1240-04; b) 15249-21 SPINAL (DD) 22/25G QUINCKE W/DRUGS. Recall # Z-1241-04; c) 15524-20 SPINAL (DD) 22G QUINCKE 25G DIAMOND POINT W/DRUGS. Recall # Z-1242-04; d) 15545-20 SPINAL(DD) 25G W/DRUGS. Recall # Z-1243-04; e) 15545-21 SPINAL(DD) 25G W/DRUGS. Recall # Z-1244-04; f) 15548-20 REG ANES W/DRUGS. Recall # Z-1245-04; g) 15551-20 SPINAL(DD) 25G WHITACRE W/DRUGS. Recall # Z-1246-04; h) 15568-20 SPINAL(DD) 25G W/DRUGS. Recall # Z-1247-04; i) 15574-20 SPINAL(DD) 25G WHITACRE. Recall # Z-1248-04; j) 15583-21 SPINAL(DD) 24G EUROPEAN PENCIL POINT W/DRUGS. Recall # Z-1249-04; k) 15594-21 SPINAL(DD) 24G EUROPEAN PENCIL POINT W/DRUGS. Recall # Z-1250-04; l) 15597-20 SPINAL(DD) 25G WHITACRE W/DRUGS. Recall # Z-1251-04; m) 15626-21 SPINAL(DD) 22/25G W/DRUGS. Recall # Z-1252-04; n) 15646-20 SPINAL(DD) 27G WHITACRE W/DRUGS. Recall # Z-1253-04; o) 15648-21 SPINAL(DD) 22G WHITACRE W/DRUGS. Recall # Z-1254-04; p) 15667-20 SPINAL(DD) 26G QUINCKE W/DRUGS. Recall # Z-1255-04; q) 15674-20 SPINAL(DD) 22/24G W/DRUGS. Recall # Z-256-04; r) 15711-20 SPINAL(DD) 27G QUINCKE W/DRUGS. Recall # Z-1257-04; s) 15776-20 REG ANES W/DRUGS. Recall # Z-258-04; t) 15810-21 SPINAL(DD) 24G SPROTTE W/DRUGS. Recall # Z-1259-04; u) 15816-21 SPINAL(DD) 27G QUINCKE W/DRUGS. Recall # Z-1260-04; v) 15830-21 SPINAL(DD) 25G WHITACRE W/DRUGS. Recall # Z-1261-04; w) 15848-20 SPINAL(DD) 24G SPROTTE W/DRUGS. Recall # Z-1262-04; x) 15876-20 SPINAL(DD) 25G WHITACRE W/DRUGS. Recall # Z-1263-04; y) 15955-21 SPINAL(DD) 25G WHITACRE W/DRUGS. Recall # Z-1264-04; z) 15961-20 SPINAL(DD) 25G WHITACRE W/DRUGS. Recall # Z-1265-04; aa) 15963-20 SPINAL(DD) 22G WHITACRE W/DRUGS. Recall # Z-1266-04; bb) 15973-21 SPINAL(DD) 25G WHITACRE W/DRUGS. Recall # Z-1267-04; cc) 15995-20 SPINAL(SDD) 25G QUINCKE W/DRUGS. Recall # Z-1268-04; dd) 4745-20 SADDLE BLOCK 26G W/DRUGS. Recall # Z-1269-04; ee) 4792-20 SADDLE BLOCK 22G W/DRUGS. Recall # Z-1270-04; ff) 4795-21 SADDLE BLOCK 25G QUINCKE W/DRUGS. Recall # Z-1271-04; gg) 4804-20 SPINAL(DD) 22G WHITACRE W/DRUGS. Recall # Z-1272-04; hh) 49651-22 SPINAL 22G PENCIL POINT W/DRUGS. Recall # Z-1273-04; ii) 49651-24 SPINAL 24G EUROPEAN PENCIL POINT W/DRUGS. Recall # Z- 1274-04; jj) 49651-25 SPINAL 25G PENCIL POINT W/DRUGS. Recall # Z-1275-04; kk) 49651-27 SPINAL 27G PENCIL POINT W/DRUGS. Recall # Z-1276-04; ll) 49652-25 SPINAL 25G PENCIL POINT W/DRUGS. Recall # Z-1277-04; mm) 4965-25 SPINAL(SHB) WHITACRE W/DRUGS. Recall # Z-1278-04; nn) A1645-25 SPINAL(FL) WHITACRE W/DRUGS. Recall # Z-1279-04; oo) A2152-25 SPINAL(FL) WHITACRE W/DRUGS. Recall # Z-1280-04; pp) A2291-27 SPINAL(SDD) W/DRUGS. Recall # Z-1281-04; qq) A2526-24 SPINAL(SHB) W/DRUGS. Recall #Z-1282-04; rr) A2527-27 SPINAL(SHB) W/DRUGS. Recall # Z-1283-04; ss) A2613 SPINAL(FL) W/DRUGS. Recall # Z-1284-04; tt) A2624-22/25 SPINAL(SDD) W/DRUGS. Recall # Z-1285-04; uu) A2654-24 SPINAL(FL) W/DRUGS. Recall # Z-1286-04; vv) A2675-25 SPINAL(SHB) W/DRUGS. Recall # Z-1287-04; ww) A2705-26 SPINAL(SHB) W/DRUGS. Recall # Z-1288-04; xx) A2814 SPINAL(SDD) W/DRUGS. Recall # Z-1289-04; yy) A2832-25 SPINAL TRAY(SDD) W/DRUGS. Recall # Z-1290-04; zz) A2837 SPINAL(SDD) W/DRUGS. Recall # Z-1291-04; aaa) A2957 SPINAL(SDD) W/DRUGS K516566. Recall # Z-1292-04. bbb) A2971-25 SPINAL(SHB) W/DRUGS. Recall # Z-1293-04; ccc) A33015-25 SPINAL(SDD) W/DRUGS. Recall # Z-1294-04; ddd) A3065-25 SPINAL TRAY (SDD) W/DRUGS. Recall #Z-1295-04; eee) A3075-25 SPINAL(SDD) W/DRUGS. Recall # Z-1296-04; fff) A3077-25 SPINAL(SDD) W/DRUGS. Recall # Z-1297-04; ggg) A3121-25 SPINAL(SDD) W/DRUGS. Recall # Z-1298-04; hhh) 4795-20 SADDLE BLOCK 25G QUINCKE W/DRUGS. Recall # Z-1299-04.

REASON: Trays contain Hospira recalled, 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK).

MANUFACTURER: Conmed Corporation, Utica, NY, by letters dated June 28, 2004. Firm initiated recall is ongoing.

PRODUCT: ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). a) Cat. #60-5158-034 Spatula; b) Cat. #60-5158-234 ³J² Hook; c) Cat. #60-5158-432 ³L² Hook; d) Cat. #60-5158-934 Needle. Recall # Z-1301-04.

REASON: Insulation of some electrodes may have pulled away from the hub of the electrode exposing the conductive shaft below.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letters dated July 14, 2004. Firm initiated recall is ongoing

PRODUCT: a) Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120. Recall # Z-1302.04; b) Roche brand Reflotron GPT (ALT), 30 test strips; catalog # 745138. Recall # Z-1303.04

REASON: Coating defect may result is falsely decreased patient and/or control results.

MANUFACTURER: Wright Medical Technology Inc., Arlington, TN, by email and telephone on July 6, 2004. Firm initiated recall is ongoing.

PRODUCT: Achillon? minimally invasive Achilles tendon suture system. Recall # Z-1304-04.

REASON: Lack of sterility assurance.

MANUFACTURER: Dade Behring, Inc., Newark, DE, by letter on June 7, 2004. Firm initiated recall is ongoing.

PRODUCT: Berichrom Heparin Reagent (OWLD1l). The reagent is a component in a test kit. Recall # Z-1305-04.

REASON: Customers have reported a high rate of instrument error flags and calibration issues when using affected reagent.

MANUFACTURER: Advanced Bionics Corporation, Sylmar, CA, by letters on July 27, 3004. Firm initiated recall is ongoing.

PRODUCT: Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options. Recall # Z-1332-04.

REASON: Battery pack may overheat and cause patient burns.

MANUFACTURER: Welch Allyn Protocol, Inc., Beaverton, OR, by letters dated June 8, 2004 through July 9, 2004. Firm initiated recall is ongoing.

PRODUCT: Welch Allyn Vital Signs Monitor 5300, Series 300, Part numbers 007-0098-00 through 007-0159-00. Recall # Z-1333-04

REASON: Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts.

MANUFACTURER: Toshiba American Med Sys. Inc., Tustin, CA, by letter on June 24, 2004. Firm initiated recall is ongoing.

PRODUCT: Digital Radiography System, Model DFP-8000D. Recall # Z-1337-04.

REASON: Defect in the mirroring unit. Unloading and loading of the disk head is scheduled about 12 hours after the power-on to prevent a failure if the read/write head remains in one position over an extended period. If a write operation is requested during the operation described above, the data will not be written to the disk. When the error occurs, the DFP-8000D displays an error message and it may become impossible to acquire images. The data unwritten into disk may prevent the DFP-8000D from the recovery by rebotting.

MANUFACTURER: Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letter dated July 26, 2004. Firm initiated recall is ongoing.

PRODUCT: Accura System for Blood Filtration, a) product codes 5M5660 and b) ACCURA01 (international); a hemofiltration system. Recall # Z-1338-04.

REASON: The Accura machine display screen may go blank during patient treatment. There is a potential risk to the patient in that the operator may try to manipulate the controls in response to a blank screen, which could affect the current patient¹s treatment.

CLASS III

MANUFACTURER: Arrow International Inc., Reading, PA, by letter on June 7, 2004. Firm initiated recall is ongoing.

PRODUCT: Arrow Epidural Catheterization Kit. Product No. MC-05001. Recall # Z-1300-04. - 8 -

REASON: The recall is due to a confirmed packaging error of the wrong length epidural needle (longer than stated), date 2006-09.

MANUFACTURER: Fisher Diagnostic, A Company of Fisher Scientific LLC, Middletown, VA, by letter on July 1, 2004. Firm initiated recall is ongoing.

PRODUCT: Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests. Recall # Z-1336-04.

REASON: Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 18, 2004:

CLASS II

MANUFACTURER: Biosense Webster, Inc., Irwindale, CA, by letter dated July 15, 2004. Firm initiated recall is ongoing.

PRODUCT: Stockert 70 Radio Frequency Ablation Generator. Recall # Z-1328-04.

REASON: Generator Failure resulting in increase of catheter temperature that could not be controlled by power reduction.

MANUFACTURER: Ev3, Plymouth, MN, by letter on July 9, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Protégé GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018) (Biliary). Recall # Z- 1329-04. b) Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SERB65-10-30-120 (.035) (Biliary) . Recall # Z-1330-04.

REASON: Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. An investigation found that 6Fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6Fr 120 cm

MANUFACTURER: BD Opthalmic Systems, Waltham, MA, by telephone the week of July 19, 2004. Firm initiated recall is ongoing.

PRODUCT: BD EdgeAhead Stiletto/MVR Knife 1.1mm (19g) REF 585240. Recall # Z-1344-04.

REASON: Blade may become detached from the handle.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 11, 2004:

CLASS II

*****CORRECTION*****

Correction: The following Beckman Coulter Inc. recalls published in the Enforcement Reports of July 21, 2004, and July 28, 2004 should have been listed as Class III instead of Class II: Z-1099-04LDL Cholesterol Reagent (LDLD), Part No. 969706Z-1148-04Synchron Systems Prealbumin Reagent, Part No. 475106Z-1151-04Synchron Liquid Comprehensive Chemistry Control Serum, Part No's. 660710 and 657365Z-1152-04Array Systems Calibrator 5 (ASO)Z-1153-04Synchron Systems Lipid Calibrator (HDLD), Part No. 650218Z-1154-04Power Processor Aliquot Tube Labels, Part No. 800255Z-1155-04Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent, Part No. 469905, Lot M206161 (level 1); Part No. 465980, Lot M206192 (level 2); Part No. 465982, Lot M206194 (level 4); Part No. 465421, Lot M301121 (level 1); Part No. 465422, Lot M301122 (level 2); Part No. 465424, Lot M301124 (level 4)Z-1156-04Vigil Lipid control (levels 1-4 for ApoB Reagent)Z-1157-04Immage Antidioxyribonuclease B (DNB) Reagent, Part No. 447480.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 4, 2004:

CLASS I

MANUFACTURER: Roche Molecular Systems, Inc., Belleville, NJ, by letter on May 24, 2004. Firm initiated recall is complete.

PRODUCT: a) COBAS TaqMan Analyzer. Recall # Z-1119-04; b) COBAS TaqMan 48 Analyzers. Recall # Z-1120-04.

REASON: Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch.

MANUFACTURER: Boston Scientific Scimed, Maple Grove, MN, by letter on July 16, 2004. Firm initiated recall is ongoing.

PRODUCT: Express 2 Monorail Coronary Stent Systems (bare metal stents) ‚ balloon expandable Express 316L stainless steel Stent premounted on a MONORAIL catheter with a Dynaleap balloon. Recall # Z-1121-04.

REASON: Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure. Problem is exhibited on implantation. Stent should perform as intended after successful implantation.

CLASS II

*****CORRECTION***** Enforcement Report 04-26 for June 30, 2004, Recall # Z-1033/1034-04, has been modified. The recall is Firm initiated recall not FDA initiated recall.

MANUFACTURER: Cook, Inc., Bloomington, IN, by letters on June 10, 2004 and June 23, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Cook brand Zenith AAA Converter with the H&L-B One-Shot Introducer System, preloaded converter - proximal diameter 24 mm - distal diameter 12 mm - length 80 mm; Reorder no. ESC-24-12-80. Recall # Z-1160-04; b) Cook brand Zenith AAA Endovascular Graft Iliac Leg Extensions - diameter 14 mm - length 55 mm -introducer sheath size 14 FR; Reorder no. ESLE-14-55-TAG. Recall # Z-1161-04; c) Cook brand Reorder # PLVTW-14.0-38-30-BNS. Silhouette Transitionless Peel-Away Introducer. Recall # Z-1162-04; d) Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 103mm ipsilateral limb 133 mm ‚ delivery system 18 FR; Catalog no. TFB-22-103. Recall # Z-1163-04; e) Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 74mm ipsilateral limb 133 mm ‚ delivery system 18 FR; Catalog no. TFB-22-74. Recall # Z-1164-04; f) Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 88mm ipsilateral limb 133 mm‚ delivery system 18 FR; Catalog no. TFB-22-88. Recall # Z-1165-04; g) Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 103mm ipsilateral limb 133 mm‚ delivery system 18 FR; Catalog no. TFB-24-103. Recall # Z-1166-04; h) Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 117 mm ipsilateral limb 133 mm‚ delivery system 18 FR; Catalog no. TFB-24-117. Recall # Z-1167-04; i) Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 132mm ipsilateral limb 133 mm‚ delivery system 18 FR; Catalog no. TFB-24-132. Recall # Z-1168-04; j) Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 74mm ipsilateral limb 133 mm‚ delivery system 18 FR; Catalog no. TFB-24-74. Recall # Z-1169-04; k) Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24mm - iliac leg diameters 11 mm - main body lengths contralateral limb 88mm ipsilateral limb 133 mm‚ delivery system 18 FR; Catalog no. TFB-24-88. Recall # Z-1170-04; l) Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 103mm ipsilateral limb 133 mm‚ delivery system 18 FR; Catalog no. TFB-26-103. Recall # Z-1171-04; m) Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 117mm ipsilateral limb 133 mm‚ delivery system 18 FR; Catalog no. TFB-26-117. Recall # Z-1172-04; n) Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm - main body length contralateral limb 132mm ipsilateral limb 133 mm‚ delivery system 18 FR; Catalog no. TFB-26-132. Recall # Z-1173-04; o) Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 74mm ipsilateral limb 133 mm‚ delivery system 18 FR; Catalog no. TFB-26-74. Recall # Z-1174-04; p) Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm‚ main body lengths contralateral limb 88mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-26-88. Recall # Z-1175-04; q) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 10 mm - usable length 105mm - delivery system 14 FR; Catalog no. TFLE-10-105. Recall # Z-1176-04; r) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 10 mm - usable length 122mm - delivery system 14 FR; Catalog no. TFLE-10-122. Recall # Z-1177-04; s) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 10 mm - usable length 37mm - delivery system 14 FR; Catalog no. TFLE-10-37. Recall # Z-1178-04; t) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 10 mm - usable length 54mm - delivery system 14 FR; Catalog no. TFLE-10-54. Recall # Z-1179-04; u) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 10 mm‚ usable length 71mm - delivery system 14 FR; Catalog no. TFLE-10-71. Recall # Z-1180-04; v) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 10 mm - usable length 88mm - delivery system 14 FR; Catalog no. TFLE-10-88. Recall # Z-1181-04; w) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 105mm - delivery system 14 FR; Catalog no.TFLE-12-105. Recall # Z-1182-04; x) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 122mm - delivery system 14 FR; Catalog no. TFLE-12-122. Recall # Z-1183-04; y) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 37mm - delivery system 14 FR; Catalog no. TFLE-12-37. Recall # Z-1184-04; z) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 54mm - delivery system 14 FR; Catalog no. TFLE-12-54. Recall # Z-1185-04; aa) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm‚ usable length 71mm - delivery system 14 FR; Catalog no. TFLE-12-71. Recall # Z-1186-04; bb) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 88mm - delivery system 14 FR; Catalog no. TFLE-12-88. Recall # Z-1187-04; cc) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 14 mm - usable length 37mm - delivery system 14 FR; Catalog no. TFLE-14-37. Recall # Z-1188-04; dd) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 14mm - usable length 54mm - delivery system 14 FR; Catalog no. TFLE-14-54. Recall # Z-1189-04; ee) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 14 mm - usable length 71mm - delivery system 14 FR; Catalog no.TFLE-14-71. Recall # Z-1190-04; ff) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 14mm - usable length 88mm - delivery system 14 FR; Catalog no. TFLE-14-88. Recall # Z-1191-04; gg) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 16 mm - usable length 37mm - delivery system 14 FR; Catalog no. TFLE-16-37. Recall # Z-1192-04; hh) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 16 mm - usable length 54mm - delivery system 14 FR; Catalog no. TFLE-16-54. Recall # Z-1193-04; ii) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 16 mm - usable length 71mm - delivery system 14 FR; Catalog no. TFLE-16-71. Recall # Z-1194-04; jj) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 16 mm - usable length 88mm - delivery system 14 FR; Catalog no. TFLE-16-88. Recall # Z-1195-04; kk) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 18 mm - usable length 37mm - delivery system 16 FR; Catalog no. TFLE-18-37. Recall # Z-1196-04; ll) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 18 mm - usable length 54mm - delivery system 16 FR; Catalog no. TFLE-18-54. Recall # Z-1197-04; mm) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 18 mm - usable length 71mm - delivery system 16 FR; Catalog no. TFLE-18-71. Recall # Z-1198-04; nn) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 18 mm - usable length 88mm - delivery system 16 FR; Catalog no. TFLE-18-88. Recall # Z-1199-04; oo) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 20 mm - usable length 37mm - delivery system 16 FR; Catalog no.TFLE-20-37. Recall # Z-1200-04; pp) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 20 mm - usable length 54mm - delivery system 16 FR; Catalog no. TFLE-20-54. Recall # Z-1201-04; qq) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 20 mm - usable length 71mm - delivery system 16 FR; Catalog no. TFLE-20-71. Recall # Z-1202-04; rr) Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 20 mm - usable length 88mm - delivery system 16 FR; Catalog no. TFLE-20-88. Recall # Z-1203-04; ss) Cook brand Zenith AAA Iliac leg graft with the H&L-B One Shot Introducer System, Preloaded iliac leg graft ‚ distal cuff diameter 22 mm ‚ usable length 37mm ‚ delivery system 16 FR; Catalog no. TFLE-22-37. Recall # Z-1204-04; tt) Cook brand Zenith AAA Iliac leg graft with the H&L-B One Shot Introducer System, Preloaded iliac leg graft ‚ distal cuff diameter 22 mm ‚ usable length 54mm ‚ delivery system 16 FR; Catalog no. TFLE-22-54. Recall # Z-1205-04; uu) Cook brand Zenith AAA Iliac leg graft with the H&L-B One Shot Introducer System, Preloaded iliac leg graft ‚ distal cuff diameter 22 mm ‚ usable length 71mm ‚ delivery system 16 FR; Catalog no. TFLE-22-71. Recall # Z-1206-04; vv) Cook brand Zenith AAA Iliac leg graft with the H&L-B One Shot Introducer System, Preloaded iliac leg graft ‚ distal cuff diameter 22 mm ‚ usable length 88mm ‚ delivery system 16 FR; Catalog no. TFLE-22-88. Recall # Z-1207-04; ww) Cook brand Zenith AAA Iliac leg graft with the H&L-B One Shot Introducer System, Preloaded iliac leg graft ‚ distal cuff diameter 24 mm ‚ usable length 37mm ‚ delivery system 16 FR; Catalog no. TFLE-24-37. Recall # Z-1208-04; xx) Cook brand Zenith AAA Iliac leg graft with the H&L-B One Shot Introducer System, Preloaded iliac leg graft ‚ distal cuff diameter 24 mm ‚ usable length 54mm ‚ delivery system 16 FR; Catalog no. TFLE-24-54. Recall # Z-1209-04; yy) Cook brand Zenith AAA Iliac leg graft with the H&L-B One Shot Introducer System, Preloaded iliac leg graft ‚ distal cuff diameter 24 mm ‚ usable length 71mm ‚ delivery system 16 FR; Catalog no. TFLE-24-71. Recall # Z-1210-04; zz) Cook brand Zenith AAA Iliac leg graft with the H&L-B One Shot Introducer System, Preloaded iliac leg graft ‚ distal cuff diameter 24 mm ‚ usable length 88mm ‚ delivery system 16 FR; Catalog no. TFLE-24-88. Recall # Z-1211-04; aaa) Cook brand Zenith AAA Iliac leg graft with the H&L-B One Shot Introducer System, Preloaded iliac leg graft ‚ distal cuff diameter 8 mm ‚ usable length 105mm ‚ delivery system 14 FR; Catalog no. TFLE-8-105. Recall # Z-1212-04; bbb) Cook brand Zenith AAA Iliac leg graft with the H&L-B One Shot Introducer System, Preloaded iliac leg graft ‚ distal cuff diameter 8 mm ‚ usable length 88mm ‚ delivery system 14 FR; Catalog no. TFLE-8-88. Recall # Z-1213-04; ccc) Cook brand Keller-Timmermans Introducer Set, straight with Rutner adapter includes: sheath 18.0 FR, 65 cm long without wire guide; Catalog no. VSSW-18.0-38-65-0-KTI. Recall # Z-1214-04; ddd) Cook brand Keller-Timmermans Introducer Set, curved with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; Catalog no. VSSW-18.0-38-65-0-KTI-BNS. Recall # Z-1215-04; eee) Cook brand Keller-Timmermans Introducer Set, straight with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; Catalog no. VSSW-18.0-38-85-0-KTI. Recall # Z-1216-04; fff) Cook brand Keller-Timmermans Introducer Set, curved with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; Catalog no. VSSW-18.0-38-85-C-KTI. Recall # Z-1217-04; ggg) Cook brand Zenith rupture main body graft, preloaded graft measuring 22 mm diameter at promial end and 12 mm diameter at distal end, with the H&L-B One shot Introducer System, non-sterile, export only for further processing; Catalog no. ZRB-22-WCE. Recall # Z-1218-04; hhh) Cook brand Zenith rupture main body graft, preloaded graft measuring 26 mm diameter at promial end and 12 mm diameter at distal end, with the H&L-B One shot Introducer System, non-sterile, export only for further processing; Catalog no. ZRB-26-WCE. Recall # Z-1219-04.

REASON: Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.

MANUFACTURER: Respironics, Inc., Murrysville, PA, by letter on June 4, 2004. Firm initiated recall is ongoing.

PRODUCT: Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter. Recall # Z-1220-04.

REASON: A product complaint was received that the lead wire from Model 915 battery was not connected.

MANUFACTURER: Integra LifeSciences Corp, Cincinnati, OH, by facsimile and letter on June 29, 200. Firm initiated recall is ongoing.

PRODUCT: Mayfield Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020. Recall # F-1221-04.

REASON: Skull pins, which fractured below device specifications during QC testing, were distributed.

MANUFACTURER: Abbott Health Products, Inc., Barceloneta, PR, by letter dated May 28, 2004. Firm initiated recall is ongoing.

PRODUCT: TDx/TDxFLx Opiates Reagent, Product list number: 9673-60. Recall # Z-1229-04.

REASON: Abbott Diagnostics Div. Has found that the oxymorphone cross-reactivity information in the "Specific Performance Characteristics" section of the TDx/TDxFLx Opiates Reagent package insert (commodity number 32-2087/R5) does not match the current product performance.

CLASS III

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on November 3, 2003. Firm initiated recall is complete.

PRODUCT: DataLink 2000 Data Manager. Version 6.3. Recall # Z-1096-04.

REASON: Software anomaly allows results to be archived prior to validation or to be uploaded to the lab information system.

MANUFACTURER: Respironics California, Inc., Carlsbad, CA, by service technician visit beginning on February 20, 2002. Firm initiated recall is complete.

PRODUCT: Esprit Ventilator. Recall # Z-1230-04.

REASON: Flow sensors would exhibit drift.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 28, 2004:

CLASS II

****CORRECTION**** FDA needed to change the recall numbers for the following products from the July 21, 2004 Enforcement Report 04-29: PRODUCT a) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in 10 x 10 box (10 cartridges per blister pack; 10 blister packs per box; catalog number 150.0157. Former Recall # Z-1096-04; New Recall # Z-1222-04; b) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25 cartridges, 25 needles; catalog number 300.0419. Former Recall # Z-1097-04; New Recall # Z-1223-04; c) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens, 1 cartridge; catalog number 150.0042. Former Recall # Z-1098-04; New Recall # Z-1224-04; d) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25; catalog number 3001061. Former Recall # Z-1099-04; New recall # Z-1225-04; e) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens, 1 cartridge; catalog number 150.0272. Former Recall # Z-1100-04; New Recall # Z-1226-04; f) Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V infusion pumps, box of 25; catalog number 300.0420. Former Recall # Z-1101-04; New Recall # Z-1227-04; g) Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V infusion pumps, 1 cartridge; catalog number 150.0051. Former Recall # Z-1102-04. New Recall # Z-1228-04; CODE All lots.

MANUFACTURER: Integra Life Sciences Corp, Exton, PA, by telephone on March 19, 2003, and by letter on March 24, 2003. Firm initiated recall is complete.

PRODUCT: Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit No 31176. The kit contains: one Hermetic Large Style Ventricular Catheter Set, one Ventricular Drainage System, one INS-HITH Cranial Access Kit, one Sodium Chloride 10 ml, and one Suture 2-0 silk. Recall # Z-1097-04.

REASON: The outer labeling of the convenience kit indicates that an additional bottle of Sodium Chloride (saline) solution is included in the Custom Kit 31176; however, an additional bottle of 1% Xylocaine was included in the Custom Kit.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on October 10, 2003. Firm initiated recall is complete.

PRODUCT: Synchron LX Clinical Systems, Operating Software. Recall # Z-1098-04.

REASON: Numeric results are erroneously accepted by the in-house information system without qualifying symbols ì<î Or ì>î. In addition, the in-house system may interpret the results incorrectly.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on February 10, 2003. Firm initiated recall is complete.

PRODUCT: LDL Cholestrerol Reagent (LDLD) Part No. 969706. Recall # Z-1099-04.

REASON: Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on July 30, 2003. Firm initiated recall is complete.

PRODUCT: Synchron Systems Hemoglobin Alc (HbAlc) Reagent. Part 650252. Recall # Z-1101-04.

REASON: Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm.

MANUFACTURER: Medtronic Physio Control Corp., Redmond, WA, by telephone and letter dated May 2004. Firm initiated recall is ongoing.

PRODUCT: LIFEPAK 12 defibrillator/monitor Part Numbers: VLP12-02-000000 through VLP12-02-005003, AVLP12-02-000000 through AVLP12-02-005003, DVLP12-02-000000 through DVLP12-02-005003, EVLP12-02-000000 through EVLP12-02-005003, FVLP12-02-000000 through FVLP12-02-005003, LVLP12-02-000000 through LVLP12-02-005003, PVLP12-02-000000 through PVLP12-02-005003, UVLP12-02-000000 through UVLP12-02-005003. Recall # Z-1107-04.

REASON: Therapy cable doesn't meet firm's standards/may not maintain connections sufficient to support ECG monitoring, external pacing or defibrillation; ECG connector with higher than normal connection resistance resulting in intermittent ECG signal; therapy connector has potential for impact damage

MANUFACTURER: Siemens Medical Solutions, USA, Berwyn, PA, by letter on June 2, 2004. Firm initiated recall is ongoing.

PRODUCT: SIEMENS AXIOM Artis ‚ AUTOMAP FUNCTION. Recall # Z-1108-04.

REASON: Error appears in the AUTOMAP function, Module 2, when PERISTEPPING or PERIVISION is activated simultaneously that causes system to crash.

MANUFACTURER: Medtronic Inc., Cardiac Rhythm Management, Fridley, MN, by letter on April 30, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Kappa Model 701 Implantable Pulse Generators (IPGs) are pacemaker devices that provide therapies for bradycardia (slow heart rhythm). Model 701 KVDD IPGs provide atrial sensing and do not provide atrial pacing by design intent; these devices provide ventricular sensing and ventricular pacing; also by design. Recall # Z-1109-04; b) Kappa Model 901 Implantable Pulse Generators (IPGs) are pacemaker devices that provide therapies for bradycardia (slow heart rhythm). Model 901 KVDD IPGs provide atrial sensing and do not provide atrial pacing by design intent; these devices provide ventricular sensing and ventricular pacing; also by design. Recall # Z-1110-04.

REASON: Potential problems with the programmer interface. Kappa Model KVDD 701/901 IPG's that were processed through the Distribution Center Restock Tester (DCRT) have an inadvertent error of having the atrial amplitude programmed on and set to 3.5V. For the Kappa KVDD device, atrial amplitude programmed on is considered an invalid parameter by the programmer software, consequently the Model 9790 or 2090 Programmer will not allow a Real Time Telemetry (RTT) measurement to be performed upon initial device interrogation or via battery and lead impedance measurement screens. Therefore, battery measurements, estimated longevity, and lead impedance measurements are not available via RTT.

MANUFACTURER: Angiometrx Inc., Vancouver, Canada, by letter, on June 23, 2004. Firm initiated recall is ongoing.

PRODUCT: Metricath Balloon Catheter model #RX183670. Recall # Z-1111-04.

REASON: Sterility of the device could have been compromised.

MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letters on June 16, 2004. Firm initiated recall is ongoing.

PRODUCT: Cell-Dyn 1000 series platelet analyzer (model numbers 1300, 1400, 1600, 1700, 1800). Recall # Z-1112-04.

REASON: Analyzer may generate inaccurate PLT concentration counts, which may result in overestimation of true PLT concentration.

MANUFACTURER: Spinal Specialties, Inc., San Antonio, TX, by telephone and letter on June 18, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Gertie Marx PainPak, Reorder number 4060. Recall # Z-1113-04; b) Pencil Point Spinal Tray. Recall Z-1114-04.

REASON: Kit contains lidocaine, which has particulate matter in its ampule.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on September 17, 2003. Firm initiated recall is complete

PRODUCT: Synchron CX (and) Synchron LX Systems Microalbumin Calibrator. Recall # Z-1115-04.

REASON: Sample values may be decreased by between 9 and 12 percent.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on October 7, 2003. Firm initiated recall is complete.

PRODUCT: Synchron LX Clinical Systems Software. Recall # Z-1116-04.

REASON: ìInitial Rate Highî parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual.

MANUFACTURER: Abbott Laboratories Diagnostic Div, South Pasadena, CA, by letter on June 17, 2001. Firm initiated recall is complete.

PRODUCT: Aeroset Prealbumin Reagent, LN 1E02-01. Recall # Z-1117-04.

REASON: False Positive results possible.

MANUFACTURER: Medex Inc., Dublin, OH, by letters dated July 2, 2004 and telephone on July 12, 2004. Firm initiated recall is ongoing.

PRODUCT: a) IPI Ventilator Circuit with 2 Water Traps, product reorder no. 6066; SIngle Patient Use Only. Recall # Z-1122-04; b) Ventilator Circuit with ìYî & elbow with 2 Water Traps, for use with/compatible with Bennett 7200; product reorder 6072WT; SIngle Patient Use only; Recall # Z-1123-04; c) Disposable Water Trap with "T" for Ventilator Circuits; product reorder 6090; SIngle Patient Use only; IPI label. Recall # Z-1124-04; d) Disposable Water Trap with "Y" for Ventilator Circuits; product reorder 6091; SIngle PatientUse only; Recall # Z-1125-04; e) Disposable Oxygen Mask & Bag, a High Concentration Non-Rebreathing Mask, complete w/Bag and One Way Valves, w/84î Tube (3 in 1 mask); reorder no. 7020; Single Patient Only; Recall # Z-1126-04; f) Disposable Oxygen Mask & Bag, Adult Non-Rebreathing Mask w/Safety Vent and 84" Tube; reorder no. 7022; Recall # Z-1127-04.

REASON: The non-rebreathing masks and watertraps wee manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex.

MANUFACTURER: Encore Medical, LP, Austin, TX, by letter on June 30, 2004. Firm initiated recall is complete.

PRODUCT: HA Hip Stem, cementless, Part number 470-02-090. Recall # Z-1128-04.

REASON: Hip stem product was mislabeled with wrong size.

MANUFACTURER: Smiths Medical ASD, Inc., Keene, NH, by letters on July 13, and July 14, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Portex Thermovent T, Heat and Moisture Exchangers Catalog # 570016; Recall # Z-1129-04; b) ThermovenT 600, Heat and Moisture Exchangers Catalog # 580011. Recall # Z-1130-04; c) Thermovent 1200, Heat and Moisture Exchanger Catalog # 580021. Recall # Z-1131-04.

REASON: Sterility of the device is compromised due to lack of package integrity.

MANUFACTURER: Encision, Inc., Boulder, CO, by letter on July 15, 2004. FDA initiated recall is ongoing.

PRODUCT: Encision ES4107 Disposable AEM Cord, Sterile. REF ES4107. Recall # 1132-04.

REASON: Firm found pinholes in packaging which would compromise sterility.

MANUFACTURER: Braun, B Medical Inc, Allentown, PA, by letter on March 19, 2004. Firm initiated recall is ongoing.

PRODUCT: 18 G Catheter is a component in various kits. Recall # Z-1133-04.

REASON: Catheter separated from the hub.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on July 1, 2004. Firm initiated recall is ongoing.

PRODUCT: a) CryoValve, Aortic Valve, Model Number: AV00. Recall # Z-1134-04; b) CryoValve, Conduit and Pulmonary Valve, Model Number: PV00. Recall # Z-1135-04.

REASON: The sterilization cycle for the instruments used during the procurement of the tissue from the donor had expired.

MANUFACTURER: Medikmark, Inc., Waukegan, IL, by letters on July 12/15, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Staple Removal Tray/Set/Kit; a sterile Rx convenience kit containing a staple remover instrument, an alcohol prep pad, a PVP prep pad and a gauze sponge. Theses kits were marketed under the following labels, 50 kits per case: a) Medikmark inc. Staple Removal Tray, reorder no. RS-2000; b)Medikmark Inc. Staple Removal Set, reorder no. SR-2000; c) Maxxim Medical Staple Removal Kit, reorder no. SD-2000. Recall # Z-1136-04; b) MediChoice Skin Staple Remover, reorder no. SSR 1001; a sterile Rx convenience kit containing a skin staple remover, a PVP prep pad and a 3 x 3 gauze sponge; 50 kits per case; Recall # Z-1137-04. c) Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a gauze sponge. These kits were marketed under the following labels, 50 kits per case: a) Medikmark inc. Staple Removal Set, reorder no. SR-2005; b) Maxxim Medical Staple Removal Kit, reorder no. SD-2005. Recall # Z-1138-04.

REASON: The tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit.

MANUFACTURER: Zimmer Dental, Inc., Carlsbad, CA, by letter on January 13, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Advent Implant Line. Recall # Z-1139-04; b) Biovent Implant Line. Recall # Z-1140-04; c) Microvent Implant Line. Recall # Z-1141-04; d) Screwvent Implant Line. Recall # Z-1142-04; e) Swedevent Implant Line. Recall # Z-1143-04; f) Swissplus Implant Line. Recall # Z-1144-04; g) Taperlock Implant Line. Recall # Z-1145-04;

REASON: Sterility barrier compromised.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on May 20, 2003. Firm initiated recall is ongoing.

PRODUCT: Synchron Systems Prealbumin Reagent Part Number: 475106. Recall # Z-1148-04.

REASON: Instability leading to falsely elevated patient results, out of range controls, or error code.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on April 1, 2003. Firm initiated recall is complete.

PRODUCT: Synchron Liquid Comprehensive Chemistry Control Serum. Part Numbers: 660710, 657365. Recall # Z-1151-04.

REASON: The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were higher than they should be by a factor of 3 (three).

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on December 17, 2003. Firm initiated recall is complete.

PRODUCT: Array Systems Calibrator 5 Part No. 465250. Recall # Z-1152-04.

REASON: The ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letters on October 8, 2003. Firm initiated recall is complete.

PRODUCT: Synchron Systems Lipid Calibrator (HDLD) Part Number: 650218. Recall # Z-1153-04.

REASON: Incorrect units are printed in labeling but not in software.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on June 23, 2003. Firm initiated recall is complete.

PRODUCT: Power Processor Aliquot Tube Labels Part 800255. Recall # Z-1154-04.

REASON: Labels are missing an expiration date and storage instructions, increasing the likelihood that they will not be used by the expiration date or may be stored under conditions that would cause adhesive failure and loss of identity of sample or aliquot during testing.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on August 15, 2003. Firm initiated recall is complete.

PRODUCT: Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent Part No.: 469905 Lot M206161 (level 1) Part No.: 465980 Lot M206192 (level 2) Part No.: 465982 Lot M206194 (level 4) Part No.: 465421 Lot M301121 (level 1) part No.: 465422 Lot M301122 (level 2) Part No.: 465424 Lot M301124 (level 4). Recall # Z-1155-04.

REASON: LDL Cholesterol component in controls are unstable.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on August 18, 2003. Firm initiated recall is complete

PRODUCT: Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent. Recall # Z-1156-04.

REASON: Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on October 29, 2003. Firm initiated recall is complete.

PRODUCT: Immage Antidioxyribonuclease B (DNB) reagent part no. 447480. Recall # Z-1157-04.

REASON: The expiration date encoded on the IMMAFE Antideoxyribonuclease B (DNB) reagent card for lot number M106152G is incorrect and should be replaced with the one sent having a ìGî which is printed after the lot number on the reagent bar code card. Cartridge expiration dates are correct.

MANUFACTURER: PerkinElmer LAS Inc., Norton, OH, by telephone and letter on June 29, 2004. Firm initiated recall is ongoing.

PRODUCT: RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use. Recall # Z-1158-04.

REASON: Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed.

MANUFACTURER: Alsius Corp, Irvine, CA, by firm service representative on June 21, 2004. Firm initiated recall is complete.

PRODUCT: Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000. Recall # Z1159-04.

REASON: Higher than expected rate of pump alarms occur under specific conditions

CLASS III

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on June 6, 2003. Firm initiated recall is complete.

PRODUCT: a) IMMAGE IGALC Reagent Part Number: 447460. Recall # Z-1146-04; b) IMMAGE IGMLC Reagent Part Number: 447470. Recall # Z-1147-04.

REASON: Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on January 28, 2004. Firm initiated recall is ongoing.

PRODUCT: IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. Part Numbers: 446360 (250 test kit) 446260 (50 test kit) 444970 (10 test kit). Recall # Z-1149-04.

REASON: Inconsistent and incomplete results for IgG.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on June 6, 2003. Firm initiated recall is ongoing.

PRODUCT: IMMAGE IgM Reagent ‚ Part No: 447610. Recall # Z-1150-04.

REASON: Low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 21, 2004:

CLASS I

MANUFACTURER: Boston Scientific Scimed, Maple Grove, MN, by website and letter on July 2, 2004. Firm initiated recall is ongoing.

PRODUCT: TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm); and TAXUS Express Paclitaxel-Eluting Over-The-Wire Coronary Stent Systems (2.75 x 12mm). Recall # Z-1052-04.

REASON: On a few occasions the balloon has failed to deflate within one minute after deployment of the stent.

MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by telephone on June 7-8, 2004, and July 1, 2004, by letters on June 7, and July 2, 2004, and by e-mail on June 7, and June 30, 2004. Firm initiated recall is ongoing.

PRODUCT: Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lot 2510 and 2530 REF #680 1857). Each reagent pack contains 100 coated wells. Recall # Z-1053-04.

REASON: Random occurrence of false positive test results.

CLASS II

MANUFACTURER: Orbus Medical Technologies Inc, Fort Lauderdale, FL, by letter on March 19, 2004. Firm initiated recall is ongoing.

PRODUCT: Stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. Ref. Balloon-Expandable Stent and delivery System. Catalog Numbers SD186U14D SD186U24D SD366U14D SD366U24D. Recall # Z-1075-04.

REASON: Balloons have longer than expected deflation times

MANUFACTURER: Rita Medical Systems, Mountain View, CA, by letters during the week of June 21, 2004. Firm initiated recall is ongoing

PRODUCT: Dispersive Electrodes packaged in an 8x10 plastic container. Recall # Z-1076-04.

REASON: Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed.

MANUFACTURER: Abbott Labs, Morgan Hill, CA, by letters on May 11, 2004. Firm initiated recall is ongoing.

PRODUCT: GemStar® I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271. Recall # Z-1077-04.

REASON: The firm's internal testing that revealed the potential air-in-line may go undetected when the set is used at temperatures above 25°C (77° F).

MANUFACTURER: Smiths Medical ASD, Inc., Keene, NH, by telephone on June 29, 2004. Firm initiated recall is ongoing.

PRODUCT: Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x ý” Reference Number: 4313. Recall # Z-1078-4.

REASON: Sterility of product is not assured.

MANUFACTURER: Dynex Technologies, Inc., Chantilly, VA, by letters on June 11, 2004 and June 24, 2004. Firm initiated recall is ongoing.

PRODUCT: Pipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108 pipette tips per rack. Pipette tips are accessory component for Dynex Technologies proprietary automated DSX system. Recall # Z-1082-04.

REASON: An accessory sampling tip for an in vitro diagnostic test instrument may be inadequately sealed and may cause false assay patient results.

MANUFACTURER: Ossur North America Inc, Aliso Viejo, CA, by telephone and letter on June 15, 2004. Firm initiated recall is ongoing.

PRODUCT: VSP Shock Module (as part of a prosthetic foot). Recall # Z-1083-04.

REASON: Flawed shock module might cause breakage causing patient to fall.

MANUFACTURER: Varian Medical Systems, Inc., Palo Alto, CA, by telephone beginning May 27, 2004 and by letters on June 3, 2004. Firm initiated recall is ongoing.

PRODUCT: Linear accelerator workstation software suite. Recall # Z-1084-04.

REASON: An anomaly occurs in the software suite (Millennium MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1.

MANUFACTURER: Thomas Medical Products Inc, Malvern, PA, by letter on June 11, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Safe Sheath CSG (Coronary Sinus Guide)-90.09; CSG (Coronary Sinus Guide)/BCor-90/09. These sheaths packaged in 5 individual boxed kits per case carton. Recall # Z-1085-04; b) SafeSheath CSG (Coronary Sinus Guide) KR-90.09 and CSG (Coronary Sinus Guide) KR/BCor-90.09. These sheaths are packaged in 5 individual boxed kits per case carton. Recall # Z-1086-04; c) SafeSheath CSG (Coronary Sheath Guide) Multisite (MSP)-00-6.5 and CSG (Coronary Sheath Guide) Multisite-00.09. Recall # Z-1087-04; d) SafeSheath CSG (Coronary Sinus Guide) Worley-1-09 STD; CSG (Coronary Sinus Guide) Worley/BCor/-1-09; CSG (Coronary Sinus Guide)-2-09 Jumbo; CSG (Coronary Sinus Guide)/BCor/-2-09; CSG (Coronary Sinus Guide) Worley/L-1-09 Long; and CSG (Coronary Sinus Guide) Worley/L/BCor-1-09/Long. Recall # Z-1088-04.

REASON: Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.

MANUFACTURER: Vascular Solutions, Inc., Minneapolis, MN, by letter on May 21, 2004. Firm initiated recall is ongoing.

PRODUCT: The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. Recall # Z-1089-04.

REASON: The marker band in guidewire lumen could move from the manufactured location during clinical use.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letters dated June 28, 2004. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom brand TotalCare Bed System; Model P1900. Recall # Z-1090-04.

REASON: An incorrect warning label was placed on these beds. Warning should say, “do not use for life sustaining equipment.....”.

MANUFACTURER: Fox Hollow Technologies, Redwood City, CA, by telephone and letter on June 18, 2004. Firm initiated recall is ongoing.

PRODUCT: ReFORM/SilverHawk Peripheral Atherectomy Catheters, packaging currently unknown. Recall # Z-1091-04.

REASON: Gram positive Rod organisms were detected in samples after lab analysis.

MANUFACTURER: Braun B Medical Inc., Allentown, PA, by letter on March 19, 2004. Firm initiated recall is ongoing.

PRODUCT: Introcan Safety IV Catheter 22G x 1” PUR with Wings. Catalog Number 4253540 - Catalog Number 4253540. Recall # Z-1092-04.

REASON: Mislabeled product. The recalling firm received a complaint that a box of Introcan Safety Catheters, (22G x 1 inch) contained mixed 18G catheters with the same lot number.

MANUFACTURER: Bausch & Lomb Surgical, Inc., Clearwater, FL, by telephone on February 27, 2004 and March 2004. Firm initiated recall is ongoing.

PRODUCT: SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens. Recall # Z-1093-04.

REASON: Lens may be labeled with incorrect diopter size.

MANUFACTURER: Fischer Imaging Corp, Denver, CO, by telephone and letter on May 21, 2004. Firm initiated recall is complete.

PRODUCT: Fischer SenoScan True View Digital Mammography System. Recall # Z-1094-04.

REASON: Existing software may allow Image data to be truncated in the margin of the breast on processed patient images.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letters on April 1, 2004. Firm initiated recall is ongoing.

PRODUCT: Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163. Recall # Z-1095-04.

REASON: The Image Navigator feature in the MagicView 300 VA42A or VA42B software may not be imported accurately to certain CT or MR images.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letters dated May 17, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in 10 x 10 box (10 cartidges per blister pack; 10 blister packs per box; catalog number 150.0157. Recall # Z-1096-04; b) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25 cartridges, 25 needles; catalog number 300.0419. Recall # Z-1097-04; c) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens, 1 cartridge; catalog number 150.0042. Recall #Z-1098-04; d) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25; catalog number 3001061. Recall # Z-1099-04; e) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens, 1 cartridge; catalog number 150.0272. Recall #Z-1100-04; f) Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V infusion pumps, box of 25; catalog number 300.0420. Recall # Z-1101-04; g) Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V infusion pumps, 1 cartridge; catalog number 150.0051. Recall # Z-1102-04.

REASON: Lack of assurance of sterility.

MANUFACTURER: Boston Scientific Corp., Spencer, IN, by letters dated June 16, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, model M001481541; Catalog No. 48-154. Recall # Z-1104-04; b) Boston Scientific/MEDI-TECH brand Fascial Dilator, 10 FR (3.3 mm), sterile, single use only, model M001482501, REF/Catalog No. 48-250. Recall # Z-1105-04.

REASON: Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa.

CLASS III MANUFACTURER: Lifecore Biomedical, Inc., Chaska, MMN, by letter on June 3, 2004. Firm initiated recall is ongoing.

PRODUCT: TefGen is an implant material, which is intended to be used as a temporary space-making barrier over bone or other tissue. a) catalog #TFS30; b) catalog #TFR60. Recall # Z-1073-04.

REASON: Packaged product labeled catalog #TFS30, lot number 002419 actually contained catalog #TFR60, lot number 002441and vice versa.

MANUFACTURER: Adac Labs, Milpitas, CA, by letter on June 21, 2004. Firm initiated recall is ongoing.

PRODUCT: Emission Computed Tomography System. Recall # Z-1079-04.

REASON: Emission Computed Tomography System. Recall # Z-1079-04.

MANUFACTURER: Diagnostica Stago, Inc., Parsippany, NJ, by letter dated December 4, 2002. Firm initiated recall is complete

PRODUCT: FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container. Recall # Z-1080-04.

REASON: The FDP Plasma latex reagent (Reagent Vial 1) is more sensitive which may result in a weak agglutination at low concentration of FDPs.

MANUFACTURER: Diagnostica Stago, Inc., Parsippany, NY, by letter dated 12/20/2002. Firm initiated recall is complete

PRODUCT: STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of UFH assays performed on STA analyzers. Each kit contains 6 x 1 mL vials of Reagent 1 (STA Heparin Control 2) and 6 x 1 mL of Reagent 2 (STA Heparin Control 5) packaged in a white cardboard unit container. Recall # Z-1081-04.

REASON: Incorrect assay ranges on the assay value insert for Heparin Control 5.

MANUFACTURER: Boston Scientific Corp., Spencer, IN, by letter on June 30, 2004. Firm initiated recall is complete.

PRODUCT: Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; model no. M001906885. Recall # Z-1106-04.

REASON: Mislabeled as to size; 10FR are labeled as 8FR.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 14, 2004:

CLASS I

MANUFACTURER: Arjo, Inc., Roselle, IL, by letters dated June 8, 2004. Firm initiated recall is ongoing.

PRODUCT: Alenti Lift Hygiene Chair; a non-AC-powered patient lift; Model numbers CDB8003-01-US and CDB8053-01-US (with scale). Recall # Z-1046-04.

REASON: There has been an increased number of tipping incidents and subsequent patient injuries.

MANUFACTURER: Boston Scientific Corp., Natick, MA, by press release on July 2, 2004. Firm initiated recall is ongoing.

PRODUCT: TAXUSô Express2ô Paclitaxel-Eluting Coronary Stent System. Recall # Z-1052-04.

REASON: The problem consists of affected delivery catheters having resulted in slow or no balloon deflation during coronary angioplasty procedures.

MANUFACTURER: Carl Zeiss Ophthalmic Systems, Inc, Dublin, CA, by telephone or fax on June 3, 2004. Firm initiated recall is ongoing

PRODUCT: Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye. Recall # Z-1066-04.

REASON: The coating of laser mirrors in a defined manufacturing lot of the Visulink 532/U devices may partially tear open and loosen from the base plate. The mirror may misdirect the laser beam to an unintended target in or on the eye.

CLASS II *****CORRECTION***** ENFORCEMENT REPORT 04-26, JUNE 30, 2004, CLASS II ‚ INFANT VENTILATORS WITH ELECTRONIC MANOMETER, RECALL # Z-1032-4, UNDER CODES, IT IS MANOMETERS WITH PRODUCTION SERIAL NUMBERS BEGINNING WITH A ì00î PREFIX ‚ NOT VENTILATORS.

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

PRODUCT: VIDASÒ CMV IgG Assay, Catalog #30 204. Recall # Z-1047-04.

REASON: The product may give false positive results.

MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter on June 11, 2004. Firm initiated recall is ongoing.

PRODUCT: ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit). Recall # Z-1048-04

REASON: False positive results may be obtained with the identified lots when using a negative patient sample or a negative control.

MANUFACTURER: Respironics Novametrix, Inc., Wallingford, CT, by letter dated September 3, 2002 and February 24, 2004. Firm initiated recall is complete.

PRODUCT: Model 509M Pulse Oximetry Interface Module Software. Recall # Z-1049-04.

REASON: Audio alarm may fail to sound when Sp02 limits drop below the set limits.

MANUFACTURER: Baxter Healthcare Corp., Round Lake, IL, by telephone beginning on April 26, 2004. FDA initiated recall is ongoing

PRODUCT: Clintec Micromix Compounder, an I.V. solution compounder; product code 2M8290 - 1.0 mL accuracy, and product code 2M8290L - less than 1.0 mL accuracy. Recall # Z-1054-04.

REASON: The Micromix compounder may have ingredient delivery outside of the stated accuracy limits if the Vlier pin is not properly adjusted

MANUFACTURER: Ethicon Endo-Surgery, Cincinnati, OH, by letter on June 7, 2004. Firm initiated recall is ongoing.

PRODUCT: LIGACLIP ERCA Endoscopic Rotating Multiple Clip Applier (Product Code: ER320) and assorted Flex Trays(Convenience Kits), containing ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers. Recall # Z-1055-04.

REASON: This device is subject to recall due to an increased possibility of clip scissoring, which can result in less than optimal clip formation, which may or may not securely ligate tubular structures.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on June 17 and 18, 2004. Firm initiated recall is ongoing.

PRODUCT: a) CryoValve Pulmonary Valve SG. Recall # Z-1056-04; b) CryoValve Pulmonary Valve and Conduit. Recall # Z-1057-04; c) CryoValve Aortic Valve and Conduit. Recall # Z-1058-04.

REASON: The Amphotericin B Intermediate (G10030), one of the components of the antimicrobial solution, had reached expiration at the time it was utilized to manufacture the Combo Antibiotic Stock Solution (G10070).

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by a recall notice dated June 30, 2004. Firm initiated recall is ongoing.

PRODUCT: a) ACCU-CHEK Inform meter; catalog No. 3035123. Recall # Z-1060-04; b) ACCU-CHEK Inform base unit; catalog No. 035131. Recall # Z-1061-04.

REASON: Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letter dated June 17, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugate and 2- 2 x 18 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 3800458190. Recall # Z-1062-04; b) Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugate and 2- 1 x 38 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 3516989190. Recall # Z-1063-04.

REASON: Device may report falsely decreased patient results.

MANUFACTURER: Osmetech, Inc., Roswell, GA, by letter on June 22, 2004. Firm initiated recall is ongoing.

PRODUCT: Osmetech OPTI-CCA Blood Gas Analyzer, Single Use, BP7564 OPTIôE-Glu Cassettes.The cassettes are labeled, Roche OPTICCA Cassettes E-Glu. There are 25 cassettes in each box. Catalog Number BP7564, Lot #351601, 401600, 401601, 405600, 405601, 406600, 406601, 405600, 405601, 410600, 412600, 415600, 415601, 417600, 419600, 419601, 419602 and 419603. Recall # Z-1064-04.

REASON: Patient samples with high glucose concentrations, above the reportable range of the OPTI-CCA Analyzer, may be erroneously reported as ìLowî.

CLASS III

MANUFACTURER: Datascope Corp., Mahwah, NJ, by Service Representatives visits in February, 2004. Firm initiated recall is ongoing.

PRODUCT: Passport 2/Passport 2LT Vital Signs Monitor. Multi-parameter patient monitoring system. Recall # Z-1050-04.

REASON: Potential inaccurate printed information in the upper and lower margins of a print strip.

MANUFACTURER: Bayer Healthcare LLC, Elkhart, IN., by letter on or about March 12, 2003. Firm initiated recall is ongoing.

PRODUCT: Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed). Recall # Z-1051-04.

REASON: Some units may only have had 1 read head screw installed instead of the three required by the firm’s specifications.

MANUFACTURER: Toshiba American Med Sys Inc., Tustin, CA, by letter on May 31, 2004. Firm initiated recall is ongoing

PRODUCT: Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device. Recall # Z-1059-04.

REASON: Pinhole collimator defective.

MANUFACTURER: NxStage Medical, Inc., Lawrence, MA, by recall notice dated April 14, 2004. Firm initiated recall is ongoing.

PRODUCT: a) NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case. Recall # Z-1069-04; b) NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-153 Cartridge Express. 6 units per case. Recall # Z-1070-04; c) NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model # CAR-154 Cartridge Express, 6 units per case. Recall # Z-1071-04.

REASON: Pinhole leaks on the replacement (RF) side FMP bag in certain lots of its disposable cartridge balance chambers resulting in loss of dialysate or ultrafiltrate.

MANUFACTURER: Gen Probe, Inc., San Diego, CA, by fax and/or letter on June 11, 2004. Firm initiated recall is ongoing.

PRODUCT: Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001. Recall # Z-1072-04.

REASON: Reduced stability.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 7, 2004:

CLASS II

MANUFACTURER: Minxray, Inc., Northbrook, IL, by letters dated June 29, 2004. FDA initiated recall is ongoing.

PRODUCT: a) MinXray P200R24 Stationary Podiatry X-Ray System, Model PS200+. Recall # Z-0985-04; b) MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200R40 (mobile) and PW200R40 (wall mounted). Recall # Z-0986-04.

REASON: The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information.

MANUFACTURER: Spinal Concepts, Inc., Austin, TX, by letter beginning March 9, 2004. Firm initiated recall is ongoing.

PRODUCT: Ant-Cer Dynamic Cervical Plating System Literature. Recall # Z-1038-04.

REASON: Recall of product literature that describes use of the device. Product literature implies that the plates ratchet mechanism is capable of preventing off-loading of the graft in extension. While the ratchet may offer some resistance in extension, it is neither intended to prevent off-loading of the graft nor disassociation of the plates. The two functions of the ratchet are to keep the plates in position during surgery and to allow the surgeon to set the desired amount of setting by the plate.

MANUFACTURER: Digene Corp, Gaithersburg, MD, by telephone on May 28, 2004, and by letter on June 2, 2004. Firm initiated recall is ongoing.

PRODUCT: Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003. Recall # Z-1039-04.

REASON: In vitro diagnostic test kit may produce false negative clinical results.

MANUFACTURER: Medtronic Inc., Neurological & Spinal Division, Columbia Heights, MN, by letter on May 11, 2004. Firm initiated recall is ongoing.

PRODUCT: Synchromed II infusion pump. Recall # Z-1040-04.

REASON: The opposite version serial numbers are assigned to 20 mL SynchroMed II Model 8637 pumps. This size-type indication is used by the programmer to identify the pump size and can cause a limitation in the useable fill volume on a 40 mL pump and could cause some confusion related to the size of a 20 mL pump which identifies itself as a 40 mL pump.

MANUFACTURER: Argon Medical Devices, Inc., Athens, TX, by letter on June 22, 2004. Firm initiated recall is ongoing.

PRODUCT: Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each (2 per pouch), sterilized by ETO, Federal law restricts this device to sale by or on the order of a physician. Recall # Z-1044-04.

REASON: Inadequate closure compromising sterility.

MANUFACTURER: Toshiba American Med Sys Inc., Tustin, CA, by letter on May 26, 2004. Firm initiated recall is ongoing

PRODUCT: Magnetic Resonance Imaging System(s) Visart and Exelart P2/Exelart P3/Exelart SPIN and Exelart VANTAGE. Recall # Z-1045-04.

REASON: Wrong positioning may cause patient burns.

CLASS III

MANUFACTURER: The Straumann Co, Waltham, MA, by letter on May 21, 2004. Firm initiated recall is ongoing.

PRODUCT: Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. 044.088. Recall # Z-1035-04.

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

MANUFACTURER: Advance Medical Designs, Inc., Marietta, GA, by telephone on June 17, 2004, and by letter on June 18, 2004. Firm initiated recall is ongoing.

PRODUCT: AdvanceÆ Medical's, The Closed Camera System, 9" x 96" (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile. Recall # Z-1036-04. Recall # Z-1036-04.

REASON: The product may come apart when excessive force is applied to the coupler.

MANUFACTURER: Staar Surgical Co., Inc., Monrovia, CA, by letter, on June 17, 2004. Firm initiated recall is ongoing.

PRODUCT: Staar Surgical Intra Occular Lens, Collamer. Recall # Z-1037-04.

REASON: Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number.

MANUFACTURER: Lang Dental Mfg., Co., Inc., Wheeling, IL, by letters dated June 7, 2004 and June 14, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic; product code 1410, Net Wt. 45 g (2 oz.) plastic squeeze bottles and product code 1420, Net Wt. 100 g (4 oz.) plastic squeeze bottles; Recall # Z-1041-04; b) Ortho-Jet Powder, fast curing orthodontic acrylic resin; the product was packaged under the following sizes: a.1) Ortho-Jet Powder, product code 1320, 100 g plastic squeeze bottle; a.2) Biocryl Resin Acrylic, product code 040-016, 1 lb. lab pack with empty plastic squeeze bottle; b.1) Contemporary Colored Ortho-Jet Powder, Lang Dental, product code 1520, 100 g plastic squeeze bottle; b.2) Contemporary Colored Assorted Kit, product code 045-088, 2 oz. plastic squeeze bottles, 6 bottles per kit; c.1) Electric Colored Ortho-Jet Powder, product code 2720, 100 g plastic squeeze bottles and product code 2793, 45 g plastic squeeze bottles/6 per kit; c.2) Tropical Tones Acrylic Resin, product code 045-052, 4 oz. plastic squeeze bottle. Recall # Z-1042-04; c) Jet Denture Repair Acrylic, fast curing denture repair resin; product code 1220, 100 gram plastic squeeze bottle and product code 1223 100 gram plastic squeeze bottle, professional package. Recall # Z-1043-04.

REASON: The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.

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