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FDA Recalls

July 2, 2003 - December 31, 2003

• Recalls as of December 31, 2003
• Recalls as of December 24, 2003
• Recalls as of December 17, 2003
• Recalls as of December 10, 2003
• Recalls as of December 3, 2003
• Recalls as of November 26, 2003
• Recalls as of November 19, 2003
• Recalls as of November 12, 2003
• Recalls as of November 05, 2003
• Recalls as of October 29, 2003
• Recalls as of October 22, 2003
• Recalls as of October 15, 2003
• Recalls as of October 8, 2003
• Recalls as of September 24, 2003
• Recalls as of September 17, 2003
• Recalls as of September 10, 2003
• Recalls as of August 27, 2003
• Recalls as of August 20, 2003
• Recalls as of August 6, 2003
• Recalls as of July 30, 2003
• Recalls as of July 23, 2003
• Recalls as of July 16, 2003
• Recalls as of July 9, 2003
• Recalls as of July 2, 2003

Attention all mdi Clients:

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 31, 2003:

CLASS II

MANUFACTURER: Danatech Medical Systems Inc., Miami, FL, by letter on December 5, 2003. FDA initiated recall is ongoing.

PRODUCT: Sonotrax Handheld Fetal Doppler Series and includes the Basic and Lite models. Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate. Recall # Z-0232-04.

REASON: This prescription device, without an approved 510K, was distributed to unauthorized consumers, mostly pregnant women, on the internet.

CLASS III

MANUFACTURER: Kendall Healthcare Products Co., Mansfield, MA, by letters on December l, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192. Recall # Z-0233-04; b) Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195. Recall # Z-0234-04.

REASON: Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5 Fr x 16.0 cm.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 24, 2003:

CLASS II

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by technical service bulletins in February 2003. Firm initiated recall is complete.

PRODUCT: ARCHITECT Processing Module. Recall # Z-0172-04

REASON: If the interlock cable connected to the door lid sensor is disconnected or fails, the lid is detected as closed even though it may be open.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated November 12, 2003. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom brand Resident LT bed ambulatory assist bar accessory; accessory P865A. Recall # Z-0206.4

REASON: The ambulatory assist bar may not lock into position and may come out of place due to incorrect assembly.

MANUFACTURER: AGFA Corp., Greenville, SC, by letter on November 25, 2003. Firm initiated recall is ongoing

PRODUCT: Scopix( LR 5200P( Laser Imagers, Type 8394/600, Model number LR 5200P, Catalog number EMQT S000. Recall # Z-0207-4.

REASON: The GS1 circuit board may fail resulting in smoke or fire

MANUFACTURER: Abbott Laboratories Diagnostic Div., South Pasadena, CA, by telephone and letter on November 3, 2003. Firm initiated recall is ongoing.

PRODUCT: Aeroset Phenobarbital, LN 1E08-01. Recall # Z-0208-04.

REASON: Assay is imprecise.

MANUFACTURER: Baxa Corp, Englewood, CO, by telephone and fax on November 7, 2003. Firm initiated recall is ongoing

PRODUCT: Exacta-Mix 2400 pharmacy compounding system. Recall # Z-0210-04.

REASON: If device stops due to an alarm or operator pause, inlet valves will remain open, allowing some unwanted mixing of ingredients in the valve chamber

MANUFACTURER: Interpore Cross International, Inc., Irvine, CA, by letter on November 7, 2003. Firm initiated recall is ongoing.

PRODUCT: C-Tek Anterior Cervical Plate System: 2.3mm/4.0mm Step Drill-14mm & 2.3mm/4.0mm Step Drill-16mm. Catalog # 1100-9019 & # 1100-9020. Recall # Z-0211-04.

REASON: Step drills from Lot 25947

CLASS III

MANUFACTURER: Konica Medical Imaging, Inc., Wayne, NJ, by letter on October 9, 2003. Firm initiated recall is ongoing.

PRODUCT: Konica Minolta Duplicating Film Emulsions, Konica Medical Film. Film type SR-DUP 8x10, 10x12, 11x14, and 14x17. Film type PPD DUP 10x12 only. SR-DUP C 14x17. Recall # Z-0150-04.

REASON: Loss of detail at density of 1.00 to 2.00, on certain bony structures found in original clinical films.

MANUFACTURER: Becton Dickinson & Co., Sparks, MD, by fax and letter on October 10, 2003. Firm initiated recall is ongoing.

PRODUCT: Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vitalex), microbiological media plates, Catalog #221267, packaged in cardboard carton, 100 plates per carton. Recall # Z-0164-04.

REASON: Microbiological media may exhibit reduced colony size of bacteria, Haemophilus species.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by visit starting on October 16, 2003. Firm initiated recall is ongoing.

PRODUCT: Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata, Syngo Sonata Upgrade, Syngo Symphony, Syngo Symphony Q, and Syngo Symphony Upgrade. Model numbers 4772906, 7106995, 7104693, 5751438, 7106714, 7104719, 7106425, 7104594, 4772971, and 7106557. Recall # Z-0175-03.

REASON: Equipment SAR monitor does not accept new patient data, incorrect RF levels may be administered to the patient.

MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter on November 5, 2003. Firm initiated recall is ongoing.

PRODUCT: Architect Anti-HBs Reagent Kit: a) list 7C18-20, 4x100 tests; b) list 7C18-25, 100 tests. Recall # Z-0209-04.

REASON: Aspiration errors in the conjugate component due to microbial contamination of the conjugate.

MANUFACTURER: Kendall Healthcare Products Co, Mansfield, MA, by letter on December 1, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, pheresis, and infusion. Reference: 8888-135192. Recall # Z-0233-04; b) Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195. Recall # Z-0234-04.

REASON: Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 17, 2003:

CLASS I

MANUFACTURER: Respironics, Inc., Murrysville, PA, by telephone on September 29, 2003. Firm initiated recall is complete.

PRODUCT: a) ComfortGel Nasal Mask size small. Recall # Z-0178-04; b) ComfortGel Nasal Mask size medium. Recall # Z-0179-04; c) ComfortGel Nasal Mask size large. Recall # Z-0180-04.

REASON: Product does not contain built in exhalation port.

CLASS II

MANUFACTURER: Plus Orthopedics, San Diego, CA, by letters on September 9, 2003. Firm initiated recall is ongoing.

PRODUCT: TC-PLUS Solution Femoral Component Size 12L, part 21041-C. Recall # Z-0170-04.

REASON: Inaccurate dimensions of the device.

MANUFACTURER: Stryker Instruments, Instruments Div., Kalamazoo, MI, by letters dated November 12, 2003. Firm initiated recall is ongoing.

PRODUCT: Stryker brand Ortho Tec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000. Recall # Z-0171-04.

REASON: Product sterility may have been compromised by an inadequate package seal.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on June 6, 2002. Firm initiated recall is ongoing.

PRODUCT: AxSYM Analyzer, Small Heater Block Clamp. Recall # Z-0173-04.

REASON: Clamp can cause misaligned seating of heater block resulting in inaccurate dispension of MEIA Wash Buffer or MUP into the reaction cell. Causes inconsistent results.

MANUFACTURER: Invacare Corporation, Elyria, OH, by telephone and letters on June 9, 2003. Firm initiated recall is ongoing.

PRODUCT: Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak. Recall # Z-0174-04.

REASON: Pull tube on bed may bend or separate causing inoperability of bed or head section to fall.

MANUFACTURER: Varian Brachytherary Virginia, Charlottesville, VA, by Customer Technical Bulletin on May 21, 2003 and by letter on October 31, 2003. Firm initiated recall is ongoing

PRODUCT: BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Recall # Z-0176-04.

REASON: The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to administer an incorrect treatment to the patient.

MANUFACTURER: Baxter Healthcare Corp., Round Lake, IL, by letters dated October 30, 2003. Firm initiated recall is ongoing.

PRODUCT: CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; 24 units per case. Recall # Z-0177-04.

REASON: Use of the dialyzers may cause iritis (red eye) patient reactions.

MANUFACTURER: Bock, Otto, Orthopedic Ind., Inc., Minneapolis, MN, by letters dated October 23, 2003. Firm initiated recall is ongoing.

PRODUCT: Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269-06-027_X, R32651001-012, HRK3283=01-026_X, HRK3269=01-026_X, HRK3283=02-026_X, HRK3269=02-026_X, HRK3283=03-027_X, HRK3269=03-027_X, HRK3283=04-027_X, HRK3269=04-027_X, HRK3283=05-026_X, HRK3269=05-026_X, and HRK3283=06-027_X. Recall #Z-0181-04.

REASON: Under certain conditions the tilt mechanism of the strollers may not function properly allowing the child to fall out if the seat belt is not fastened.

MANUFACTURER: The OR Group, Acton, MA, by letter on November 6, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Ronci Surgical Universal Imaging Extension used with the Ronci Pain Management Table System Catalog Number: R-934-25A. Recall # Z-0182-04; b) Stryker Universal Imaging Extension (OEM) Catalog Number: R--934-TRIO-A1. Recall # Z-0183-04; c) Trumpf Universal Imaging Extension (OEM) Catalog Number: F-PMT-A. Recall # Z-0184.04.

REASON: Imaging table with extension may fail if the table leg is incorrectly positioned and the load exceeds the maximum weight of 400 lb.

MANUFACTURER: Ross Products Division, Abbott Laboratories, Columbus, OH, by telephone, fax, and letter on November 14. 2003. Firm initiated recall is ongoing.

PRODUCT: a) Ross 14 FR Gastrostomy Tube, Item # 152. Recall # Z-0185-04; b) Ross 16 FR Gastrostomy Tube, Item # 153. Recall # Z-0186-04; c) Ross 18 FR Gastrostomy Tube, Item # 154. Recall # Z-0187-4; d) Ross 20 FR Gastrostomy Tube, Item # 155. Recall # Z-0188-04; e) Ross 22 FR Gastrostomy Tube, Item # 156. Recall # Z-0189-04; f) Ross 24 FR Gastrostomy Tube, Item # 159. Recall # Z-0190-04; g) Ross 26 FR Gastrostomy Tube, Item # 50158. Recall # Z-0191-04; h) Ross 16 FR Easy-Feed Gastrostomy Tube, Item # 50112. Recall # Z-0192-04; i) Ross 18 FR Easy-Feed Gastrostomy Tube, Item # 50114. Recall # Z-0193-04; j) Ross 20 FR Easy-Feed Gastrostomy Tube, Item # 50116. Recall # Z-0194-04; k) Ross 22 FR Easy-Feed Gastrostomy Tube, Item # 50118. Recall # Z-0195-04; l) Ross 14 FR Magna-Port Gastrostomy Tube, Item # 51358. Recall # Z-0196-04; m) Ross 16 FR Magna-Port Gastrostomy Tube, Item # 51360. Recall # Z-0197-04; n) Ross 18 FR Magna-Port Gastrostomy Tube, Item # 51362. Recall # Z-0198-04; o) Ross 20 FR Magna-Port Gastrostomy Tube, Item # 51364. Recall # Z-0199-04; p) Ross 22 FR Magna-Port Gastrostomy Tube, Item # 51366. Recall # Z-0200-04; q) Ross 24 FR Magna-Port Gastrostomy Tube, Item # 54738. Recall # Z-0201-04; r) Ross 28 FR Magna-Port Gastrostomy Tube, Item # 54736. Recall # Z-0202-04; s) Ross 18 FR Introducer Gastrostomy Kit with Brown Mueller T-Fastener Set, Item # 50190. Recall # Z-0203-04; t) Ross 22 FR Versa-PEG Gastrostomy Kit, Item # 50520. Recall # Z-0204-04; u) Ross 18 FR Lap G Laparoscopic Gastrostomy Kit with Brown Mueller T-Fastener Set, Item # 51174. Recall #Z-0205-04.

REASON: An increase in reported balloon failures, which may result in tube displacement.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 10, 2003:

CLASS I

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by facsimile on August 12, 2003. Firm initiated recall is ongoing.

PRODUCT: Calculator/Data Processing Module for Clinical Use. Recall # Z-0007-04

REASON: Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review.

CLASS II

MANUFACTURER: Qualigen Inc., Carlsbad, CA, by letter starting September 24, 2003. Firm initiated recall is ongoing.

PRODUCT: FastPack Total Testosterone Immunoassay. Device to determine quantitative total testosterone in human serum. Catalog #: 25000009. Recall # Z-0090-04

REASON: Kits may produce results that are falsely elevated.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on July 7, 2003. FDA initiated recall is ongoing.

PRODUCT: Misys Laboratory System. Recall # Z-0151-04.

REASON: Software defect causes orders to be lost under certain conditions of use. A typographical error at the Accept/Modify/Reject prompt will cause the order not to be processed by the system.

MANUFACTURER: Maximus Medical Products Inc, Costa Mesa, CA,

PRODUCT: 100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 50 per box. Product No. MFS102. Recall # Z-0152-04.

REASON: Mislabeled with wrong drop size drip chamber specification.

MANUFACTURER: DentSply-Professional Division, Des Plaines, IL, by telephone and letters on October 14-16, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Midwest Tradition PB Non-Fiber Optic High Speed Handpiece with Push Button Chuck (4 tube connection), catalog #790044. Recall # Z-0154-04; b) Midwest Tradition PB Fiber Optic High Speed Handpiece with Push Button Chuck (5 tube connection), catalog #790045 and 790045T. Recall # Z-0155-04; c) Midwest XGT High Speed Handpiece with Fiber Optics and Push Button Chuck, catalog #790000. Recall # Z-0156-04; d) Midwest Tradition PB High Speed Handpiece with Push Button Chuck, catalog #790042. Recall # Z-0157-04.

REASON: Small Cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.

MANUFACTURER: Merit Medical Systems, Inc, South Jordan, UT, by sales representatives on November 5-7, 2003. Firm initiated recall is complete.

PRODUCT: a) UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiographic Catheter, Sterile, Merit Medical. Catalog Number7779-10. Recall # Z-0158-04; b) UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, Merit Medical. Catalog Number 5614-A0. Recall # Z-0159-04.

REASON: Angiographic catheter tips may separate during use.

MANUFACTURER: Vygon US LLC, Norristown, PA, by letters on September 9, 2003. Firm initiated recall is complete

PRODUCT: a) Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle. Catalog number SP01. Recall # Z-0160-04; b) Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with T handle. Catalog number SP02. Recall # Z-0161-04.

REASON: Mislabeled as sterile.

MANUFACTURER: Medstone International, Inc., Aliso Viejo, CA, by safety alert on July 29, 2003 and August ll, 2003. Firm initiated recall is complete.

PRODUCT: URO PRO Plus Digital Urology Imaging System. Recall # Z-0162-04.

REASON: X-ray tube arm and collimator fell and fractured patient's ribs.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on October 31, 2003. FDA initiated recall is ongoing

PRODUCT: ICON 25 hCG Test Kit. Recall # Z-0163-04.

REASON: False negative urine results are being observed at an increasing rate.

MANUFACTURER: Abbott Laboratories Diagnostic Div., South Pasadena, CA,

PRODUCT: AEROSET Immunoglobulin M, list number 1E01-01. Recall # Z-0165-04.

REASON: Assay may produce falsely low IgM results without error codes when testing specimens contain elevated serum paraproteins associated with various myeloma or other malignancies.

MANUFACTURER: Portex Inc., Keene, NH, by letter on October 10, 2003. Firm initiated recall is ongoing.

PRODUCT: Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine, Lidocaine, Lidocaine in Dextrose and Tetracaine. Catalog Number: 15545-20. Recall # Z-0166-04.

REASON: Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on November 4, 2003. Firm initiated recall is ongoing.

PRODUCT: CeyoValve Pulmonary Valve & Conduct. Model Number PV00. Recall # Z-0167-04.

REASON: CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site.

MANUFACTURER: Medtronic MiniMed, Northridge, CA, by letter on August 29, 2003 and September 12, 2003. Firm initiated recall is complete.

PRODUCT: Paradigm Model 511 Insulin Infusion Pumps. Recall # Z-0168-04.

REASON: Water ingresses into the device when in prolonged contact with water causing device to malfunction.

MANUFACTURER: Medtronic MiniMed, Northridge, CA, by letter on February 15, 2002, and in the "Positive Pumping Newsletter winter (2002/2003) edition. Firm initiated recall is ongoing.

PRODUCT: Ambulatory infusion pump. Model 511. Recall # Z-0169-04.

REASON: Non delivery of insulin by pump after electrostatic discharge.

Please visit our website at www.mdiconsultants.com for more informations on mdi’s services, staff and items of interest.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 3, 2003:

CLASS II

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

PRODUCT: Coulter DNA Prep Reagents Kit Part 6607055. Recall # Z-0136-04

REASON: Labeling Error-Omission of "Research Use Only".

MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by letter dated October 3, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Monarch Inflation Device and Fluid Dispensing Syringe - Latex Free MERIT MEDICAL. Sterile if package is unopened or undamaged. Part # IN2125/B. Recall # Z-0137-04; b) IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in part: "NTELLISYSTEM 25 WITH MAP152 MAP152 CONTAINS: MERIT ACCESS PLUS LARGE BORE HEMOSTASIS VALVE, TORGUE DEVICE AND METAL GUIDE WIRE INSERTION TOOL...MERIT MEDICAL" Latex free. Sterile if package is unopened or undamaged. Part # 1525/B. Recall # Z-0138-04; c) VacLok Syringe. Label reads in part: ''VACLOC SYRINGE 60ml VACLOF SYRINGE-FIXED MALE LUER ... MERIT MEDICAL''. Sterile if package is unopened or undamaged. Part #VAC160. Recall # Z-0139-04; d) Inflation Kit. Label reads in part: "CUSTOM KIT...MERIT MEDICAL". Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K05-10570, K05-01536A, K05-01153C, K05-00276C, K05-0019313, K05-00077F, K05-01296A, K05-00134D, K05-01676, K05-01250, K05-00800, K05-01545, K05-00819, K05-01069C, K05-00559F, K05-50078B, K05-00116C, K05-00459C, K05-01290A,K05-01146, K05-50054D, K05-00946B, K05-00203K, K05-00682B, K05-YSI008A, K05-YPI011, K05-00746, K05-003139, K05-00751G, K05-00180G, and K05-00553F. Recall # Z-0140-04; e) Manifold Custom Kit. Label reads in part: "CUSTOM KIT...MERIT MEDICAL". Latex free, Sterile if package is unopened or undamaged. Part # K09-07862B, # K09-07873, #K09-02498F, #K09-07828b, #K09-00970J, #K09-06383B, #K09-07002A, #K09-04734D, #K09-00794K, and #K09-08037A. Recall # Z- 0141-04; f) Waste Collection Kit. Label reads in part: "CUSTOM KIT...MERIT MEDICAL". Latex free, Sterile if package is unopened or undamaged. Part # K10-01047. Recall # Z-0142-04.

REASON: There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the separated trays.

MANUFACTURER: ConMed Electrosurgery, Centennial, CO, by letter on September 15, 2003. Firm initiated recall is ongoing.

PRODUCT: Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230). Recall # Z-0144-04.

REASON: The Hyfrecator 2000 units were released without documented adherence to their voltage output specification.

MANUFACTURER: Teledyne Analytical Instruments, Rowland Heights, CA, by letter on October 27, 2003. Firm initiated recall is ongoing.

PRODUCT: Portable Oxygen Analyzer. Recall # Z-0145-04.

REASON: Potential failure to display the battery low light to the end-user.

MANUFACTURER: Kyphon, Inc., Sunnyvale, CA, by letter and on-site visit on October 13, 2003. Firm initiated recall is ongoing.

PRODUCT: a) KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. Kyphon Catalog Number: A08A. The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation Syringe. This medical device is provided as an individual stand-alone package (which also contains an accessory locking syringe device) and as an individually packaged component of the KyphoPak Tray. The Inflation Syringe packaging and contents are identical whether provided as a stand-alone package or as a component of the KyphoPak Tray. Recall # Z-0146-04; b) KyphXR brand KyphoPak Tray, a Introducer Tool kit for Inflation Syringe Kyphon Catalog Number: KPT1001, KPT1002, KPT1003, KPT1501, KPT1503, KPT2002, KPT2003 The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation Syringe. This medical device is provided as an individual stand-alone package (which also contains an accessory locking syringe device) and as an individually packaged component of the KyphoPak Tray. The Inflation Syringe packaging and contents are identical whether provided as a stand-alone package or as a component of the KyphoPak Tray. Recall # Z-0147-04.

REASON: Devices for which sterility may be compromised as evidenced by a loss of package integrity.

CLASS III

MANUFACTURER: Arrow International, Inc., Reading, Pa, via telephone on October 22, 2003. Firm initiated recall is ongoing.

PRODUCT: 10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set. Catalog/Model number CL-07011. Recall # Z-0088-04.

REASON: Package lid identifies the contents incorrectly.

MANUFACTURER: Anika Therapeutics, Woburn, MA, by letter on October 8, 2003. Firm initiated recall is ongoing.

PRODUCT: a) ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000. Recall # Z-0108-04; b) Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. P/N490-001. Recall # Z-0109-04. c) Amvisc Sodium Hyaluronate 0.8 mL 12 mg/mL Syringe. Sterile. RX. For intraocular use. Product Number: 780A. Recall # Z-0110-04; d) DomiVisc Sodium Hyaluronate 0.8 mL 12 mg.mL Syringe. Sterile.RX. For intraocular use Product Numbner; P012-80A. Recall # Z-0111-04; e) Hialuronato Sodico Sodium Hyaluronate 12 mg/mL 1X0.8 Ml Sterile. RX. For Intraocular use. Product Number: 014-180A. Recall # Z-0112-04; f) Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml For European Distribution. Recall # Z-0113-04.

REASON: Stability failure at the 20 month for viscosity specification.

MANUFACTURER: Ventana Medical Systems, Inc., Tucson, AZ, by letter on April 4, 2003. Firm initiated recall is ongoing.

PRODUCT: CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number 790-2939. Recall # Z-0115-04.

REASON: Increased level of non-specific or background staining.

MANUFACTURER: Datex-Ohmeda, Inc., Madison, WI, by letters dated October 15, 2003. Firm initiated recall is ongoing.

PRODUCT: Datex-Ohmeda Cardiocap/5 Patient Monitors.

Recall # Z-0143-04.

REASON: Datex-Ohmeda Cardiocap/5 Patient Monitors have bracket pins which do not adequately secure them to their optional mounting stand so the monitors may fall.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 26, 2003:

CLASS II

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by service technician visit beginning on November 13, 2003. Firm initiated recall is ongoing.

PRODUCT: OEC UroView 2800 Digital Imaging System. Recall # Z-0604-03.

REASON: "Condition 1": Involving systems, manufactured prior to June 25, 2002, that include the optional 15 pulse per second fluoroscopic mode. In these systems, it is possible for the maximum entrance exposure rate (EER) to exceed the regulatory limit of 20 R/minute in high-level control (HLC) mode. "Condition 2": Involving systems equipped with radiographic spot film mode manufactured prior to September 9, 2002. This condition is met when the FILM button is not held down continuously until the adjacent LED remains lit and control panel display indicates FILM MODE READY, causing the system to not readjust the x-ray field size to the proper fluoroscopic setting for fluoroscopic procedures. When this occurs, the x-ray field size for any subsequent fluoroscopic exposures may be larger than the patient anatomy being viewed.

MANUFACTURER: Misonix, Inc., Farmingdale, NY, by letter on August 13, 2003, and September 17, 2003. Firm initiated recall is ongoing.

PRODUCT: LySonix 2000 Ultrasonic Surgical Systems, Model No. LY-2000. Recall # Z-0070-04.

REASON: Firm received complaints of tingling or static shock sensation to end users caused by forcing the output connector into its receptacle misaligned. The misalignment causes additional voltage to appear on the patient probe.

MANUFACTURER: Boston Scientific, San Jose, CA, by letter on September 22, 2003. Firm initiated recall is ongoing.

PRODUCT: PeriVac( brand Pericardial Fluid Aspiration Procedure Kit (Pericardiocentensis Kit), with Pigtail Drainage Catheter; Model/Catalog Numbers: 4304 and 4305. Recall # Z-0071-04.

REASON: The product has the potential to break during withdrawal process.

MANUFACTURER: Biotronik, Inc., Lake Oswego, OR, by letter dated September 24, 2003. Firm initiated recall is ongoing. PRODUCT: a) Belos DR Implantable Cardioverter Defibrillator. Recall # Z-0072-04; b) Belos DR-T Implantable Cardioverter Defibrillator. Recall # Z-0073-04; c) Belos VR Implantable Cardioverter Defibrillator. Recall # Z-0074-04; d) Belos VR-T Implantable Cardioverter Defibrillator. Recall # Z-0075-04.

REASON: Potential extended charge time anomalies.

MANUFACTURER: Biotronik, Inc., Lake Oswego, OR, by letter dated September 24, 2003. Firm initiated recall is ongoing. PRODUCT: a) Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. Recall # Z-0076-04; b) Belos VR-T Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. Recall # Z-0077-04.

REASON: Potential for early depletion of Implantable Cardioverter Defibrillator battery.

MANUFACTURER: Electro Medical Systems (EMS SA), Nyon, CH, by letter dated October 3, 2003, and October 6, 2003. Firm initiated recall is ongoing.

PRODUCT: LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703. Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700. Recall # Z-0078-04.

REASON: Failure of foot pedal to activate device.

MANUFACTURER: Rita Medical Systems, Mountain View, CA, by letters on October 6, 2003. Firm initiated recall is ongoing.

PRODUCT: RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649. Recall # Z-0087-04.

REASON: The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letters on October 16, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Terumo Advanced Perfusion System 1 Roller Pump; 4 inch diameter; Catalog number 801040. Recall # Z-0102-04; b) Terumo Advanced Perfusion System 1 Roller Pump; 6 inch diameter; Catalog number 801040. Recall # Z-0103-04.

REASON: The roller pump tube clamp mechanism may fail to release, making it difficult to remove or insert the tubing, and thereby delaying perfusion.

MANUFACTURER: Zimmer Inc., Warsaw, IN, by letter dated October 15, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 2 1/2 inches in length. Catalog # 281-01-01. Recall # Z-0116-04; b) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 2 3/4 inches in length. Catalog # 281-01-02. Recall # Z-0117-04; c) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 3 inches in length. Catalog # 281-01-03. Recall # Z-0118-04; d) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 3 1/4 inches in length. Catalog # 281-01-04. Recall # Z-0119-04; e) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 3 1/2 inches in length. Catalog # 281-01-05. Recall # Z-0120-04; f) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 3 3/4 inches in length. Catalog # 281-01-06. Recall # Z-0121-04; g) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 4 inches in length. Catalog # 281-01-07.Recall # Z-0122-04; h) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 4 1/4 inches in length. Catalog # 281-01-08. Recall # Z-0123-04; i) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 4 3/4 inches in length. Catalog # 281-01-10.Recall # Z-0124-04; j) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 5 inches in length. Catalog # 281-01-11. Recall # Z-0125-04; k) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 5 3/4 inches in length. Catalog # 281-01-14. Recall # Z-0126-04; l) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 6 inches in length. Catalog # 281-01-15. Recall Z-0127-04; m) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 3 inches in length. Catalog # 281-02-03. Recall Z-0128-04; n) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 3 1/4 inches in length. Catalog # 281-02-04. Recall Z-0129-04; o) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 3 1/2 inches in length. Catalog # 281-02-05. Recall Z-0130-04; p) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 3 3/4 inches in length. Catalog # 281-02-06. Recall Z-0131-04; q) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 4 inches in length. Catalog # 281-02-07. Recall Z-0132-04; r) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 4 1/4 inches in length. Catalog # 281-02-08.Recall Z-0133-04; s) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 4 1/2 inches in length. Catalog # 281-02-09. Recall Z-0134-04; t) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 4 3/4 inches in length. Catalog # 281-02-10. Recall Z-0135-04.

REASON: The pin may fail because the metal used to make the pin does not meet the firm's hardness specification.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 19, 2003:

CLASS II

MANUFACTURER: SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, Algete (Madrid) Spain. FDA initiated recall is ongoing. Recalling Firm: Sedecal USA, Inc., Arlington Heights, IL, by an Important Safety Notice dated October 27, 2003.

PRODUCT: Sedecal SP-HF 4.0 Portable X-Ray System. Recall # Z-0001-04.

REASON: A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in the SP-HF-4.0 Portable Systems not complying with the U.S. Federal performance standard.

MANUFACTURER: Propper Manufacturing Co., Inc., Long Island City, NY, by fax on August 9, 2002 and November 27, 2002. Firm initiated recall is complete.

PRODUCT: Propper brand cal-mark(, Micro-Hematocrit Calibrated Capillary Tubes, Calibrated-Heparinized, reorder no. 043021, 6 Vials, 100 Tubes per Vial, Length 75 mm., 0.55 mm. I.D., 1040-1.75mm. O.D. Calibrated 60mm from end for use in direct reading centrifuges. Recall # Z-0051-04.

REASON: Deviation in capillary tubes could cause a 10% increase in read out values, which could make a slight anemic patient appear to have a normal reading.

MANUFACTURER: Hill-Rom Manufacturing, Inc, Charleston, SC, by letter on January 14, 2002. Firm initiated recall is complete.

PRODUCT: Clinitron At Home( Air Fluidized Therapy Unit. Model 206 (CS). Recall # Z-0057-04.

REASON: Power cord overheating.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on September 30, 2003. Firm initiated the recall is ongoing.

PRODUCT: AEROSET System Software, Catalog 2-95068-01 version 1.02ER000 and Catalog 2-95175-01 AEROSET System Software, version 1.02ER000 Upgrade Kit. Recall # Z-0091-04.

REASON: Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.

MANUFACTURER: General Electric Medical Systems Information Technology, Milwaukee, WI, by letter dated June 4, 2002. Firm initiated recall is ongoing.

PRODUCT: Solar 8000M Patient Monitor. Recall # Z-0092-04.

REASON: Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display, and selected gain settings for a selected waveform.

MANUFACTURER: Exactech, Inc., Gainesville, FL, by letter on June 17, 2003. Firm initiated recall is complete.

PRODUCT: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14. Product is packed in plastic Tyvek packaging and is labeled as sterile. Recall # Z-0105-04.

REASON: Instrument is excessively flexible making it unusable by the surgeon.

MANUFACTURER: Cti Pet Systems Inc., Knoxville, TN, by letter beginning October 2, 2003. Firm initiated recall is ongoing.

PRODUCT: Siemens Biograph, biograph LSO and CTI Models: Reveal RT. Recall # Z-0106-04.

REASON: CPS has found that in some instances, when the CTE-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.

MANUFACTURER: Medline Industries, Inc., Mundelein, IL, by telephone on October 7, 2003. Firm initiated recall is complete.

PRODUCT: Mdline Blue O.R. Towel, Sterile; Reorder # MDT2168204, 4 towels per pack, 20 packs per case. Recall # Z-0114-04.

REASON: The product labeled as sterile, had not gone through the sterilization process at the time of shipment

CLASS III

MANUFACTURER: Wilson-Cook Medical Inc, Winston Salem, NC, by email on April 21, 2002. Firm initiated recall is complete.

PRODUCT: ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035" Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Single Use Only, Rx Only, Catalog numbers: ZILBS-10-4, ZILBS-6-4, ZILBS-8-4, ZILBS-10-6, ZILBS-6-6, ZILBS-8-6, ZILBS-10-8, ZILBS-6-8, ZILBS-8-8. Recall # Z-0089-04.

REASON: Complaints were reported of difficulty in stent deployment.

MANUFACTURER: Qualigen, Inc., Carlsbad, CA, by letter starting September 24, 2003 and certified or Airborne letter sent on September 29, 2003. Firm initiated recall is ongoing.

PRODUCT: FastPack Total Testosterone Immunoassay. Device to determine quantitative total testosterone in human serum. Catalog #: 25000009. Recall # Z-0090-04.

REASON: Kits may produce results that are falsely elevated.

MANUFACTURER: Sandhill Scientific, Inc., Highlands Ranch, CO, by telephone and letter on September 24, 2003. Firm initiated recall is ongoing

PRODUCT: ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system. Product Model ZAN S61C01E. Recall # Z-0104-04.

REASON: Pouch containing pediatric probes was labeled as containing adult probes.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 12, 2003:

CLASS II

MANUFACTURER: Richard Wolf Medical Instruments Corp., Vernon Hills, IL, by telephone on October 9, 2003 and follow-up visits. Firm initiated recall is ongoing.

PRODUCT: Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory to the Richard Wolf Model 2271 Ultrasound Generator Unit 2271. Model 8963.535. Recall # Z-0081-04.

REASON: The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device.

MANUFACTURER: Concentric Medical Inc, Mountain View, CA, by letters on September 24, 2003, and follow-up letters on October 17, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Concentric brand Concentric Retriever(tm) X5 Percutaneous Catheter Model REF 90035. Recall # Z-0085-04; b) Concentric brand Concentric Retriever(tm) X6 Percutaneous Catheter Model REF 90037. Recall # Z-0086-04.

REASON: The device has the potential for tip breakage during use.

MANUFACTURER: Toshiba American Medical Systems, Inc., Tustin, CA, by service representative visit starting on May 27, 2003. Firm initiated recall is ongoing.

PRODUCT: Digital Fluorographic System model DFP-2000A. Recall # Z-0100-04.

REASON: Images display with wrong patient demographics - 2 -

CLASS III

MANUFACTURER: Arrow International, Inc., Reading, PA, by letter dated September 16, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Arrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm. Catalog number AK-25703. Recall # Z-0082-04; b) Arrow central venous catheterization kit, 14 ga x 20 cm. Catalog number AK-04700. Recall # Z-0083-04; c) Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm. Catalog number CC-03600. Recall # Z-0084-04.

REASON: Wrong product in box.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 5, 2003:

CLASS II

MANUFACTURER: St. Jude Medical, Sylmar, CA, by letter dated July 31, 2003. Firm initiated recall is ongoing.

PRODUCT: Pulse Generator Pacemaker, Integrity, Identity, and Verity. Recall # Z-0052-04.

REASON: Under certain circumstances, pacemaker has a potential to deliver a short-coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shorter than anticipated pacing intervals.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated August 27, 2003. Firm initiated recall is ongoing.

PRODUCT: e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; all e.cam models: 4380213, 4380221, 5242826, 5977066, 5977074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7332625, 7332633, 7760809, 7760932, 7761161, 7823920, 7823938, 7823946, 7823953, 7823979. Recall # Z-0053-04.

REASON: The detector's radial brake may not be applied properly, allowing unintended motion which could result in injury to the patient or operator.

MANUFACTURER: Western a Scott Fetzer Co., Westlake, OH, letter on October 2, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Western Medica OPC Portable Oxygen Conserving Regulator, Model OPC-830, 1/2 - 5 LPM, packaged under the Western Medica label. Recall # Z-0054-04; b) Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM, packaged under the Lincare label. Recall # Z-0055-04; c) Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM, packaged under the Medline label. Recall # Z-0056-04.

REASON: The demand valve is defective and does not function as intended in the "Conservative Mode".

MANUFACTURER: Hill-Rom Manufacturing, Inc., Charleston, SC, by letter on August 27, 2003. Firm initiated recall is ongoing.

PRODUCT: a) FLEXICAIR(r) II, Low Airloss Therapy unit. This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators. Recall # Z-0058-04; b) FLEXICAIR MC3(r) Low Airloss Therapy unit. Recall # Z-0059-04.

REASON: Reports of patient entrapment between mattress and side-rails.

MANUFACTURER: Nova Biomedical Corporation, Waltham, MA, by telephone beginning on September 26, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394. Recall # Z-0060-04; b) Stat Profile Critical Care Expres Ionized Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Critical Care Xpress Analyzer) Part # 37271.Recall # Z-0061-04.

REASON: Degradation of the magnesium sensor could result in low ionized magnesium patient samples.

MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letters dated September 19, 2003 and October 7, 2003. Firm initiated recall is ongoing.

PRODUCT: IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A having 0 ng/mL, Calibrator B having 3 ng/mL, Calibrator C having 6 ng/mL, Calibrator D having 12 ng/mL, Calibrator E having 20 ng/mL and Calibrator F having 30 U/mL. Recall # Z-0063-04.

REASON: Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100

MANUFACTURER: Acist Medical Systems, Eden Prairie, MN, by letters dated October 2, 2003. Firm initiated recall is ongoing.

PRODUCT: ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units). Recall # Z-0064-04.

REASON: Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak.

MANUFACTURER: Cryolife Inc., Kennesaw, GA, by letter on September 25, 2003. Firm initiated recall is ongoing.

PRODUCT: CryoValve, Pulmonary Heart Valve, Donor #68830, Model #PV10. Recall # Z-0065-04.

REASON: Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a systemic infection.

MANUFACTURER: Bayer Corp., Medfield, MA, by telephone and letter dated September 26, 2003. Firm initiated recall is ongoing.

PRODUCT: Bayer Rapidpoint 405 Blood Gas Analyzer. Recall # Z-0066-04.

REASON: Potential for bias shift in p02 values due to air bubble in sample path.

MANUFACTURER: Beckman Coulter, Inc., Brea, Ca, by letter on September 29, 2003. Firm initiated recall is ongoing.

PRODUCT: Synchron CX4, CX5 and CX9 Pro Systems. Recall # Z-0067-04.

REASON: Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature.

MANUFACTURER: Wilson-Cook Medical Inc., Winston-Salem, NC, by Fax or E-mail in August/September, 2002. Firm initiated recall is ongoing.

PRODUCT: Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only. Recall # Z-0068-04.

REASON: The product was labeled with a 5 year expiration date instead of a 1 year expiration date.

MANUFACTURER: Remel, Lenexa, KS, by letter dated October 2, 2003. Firm initiated recall is ongoing.

PRODUCT: Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and 100 per case (Cat. #01886). Recall # Z-0069-04.

REASON: Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae.

DEVICES - CLASS III

MANUFACTURER: MicroAire Surgical Instruments, Charlottesville, VA, by letter on September 23, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Wire Driver Coupler, Model 7100-045, a component of MicroAire Drill/Reamer Model 7500. Driver couplers are reuseable medical devices, non-sterile, packed one per box and labeled in part. Recall # Z-0043-04; b) Pin Driver Coupler, component of MicroAire Drill\Reamer Model 7500. Driver couplers are reuseable medical devices, non-sterile, packed one per box and labeled in part. Recall # Z-0043-04.

REASON: Wiring pin locking mechanism defective, potential to come apart in surgical site.

MANUFACTURER: Meridian Bioscience, Inc., Cincinnati, OH, by letter on September 23, 2003. Firm initiated recall is ongoing.

PRODUCT: Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096. Recall # Z-0062-04.

REASON: The kits were packaged with incorrect dispensing pipettes.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 29, 2003:

CLASS II

MANUFACTURER: Sedecal SA, Madrid, Spain. Firm initiated recall is ongoing. Recalling Firm: Sedecal USA, Inc, Arlington Heights, IL, by manufacturer representative visit on or after October 10, 2003.

PRODUCT: Sedecal Portable X-Ray System. Model Number SP-HF-4.0. Recall # Z-0001-04.

REASON: A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in your SP-HF-4.0 Portable Systems not complying with the U.S. Federal performance standard.

CLASS III

MANUFACTURER: Cordis Neurovascular, Inc., Miami Lakes, FL, by e-mail on August 20, 2001 and by letters on October 19, 2001. Firm initiated recall is complete.

PRODUCT: Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual marker band tip. Catalog No. 606-2511 FX UPN H7396062511FX3. Recall # Z-0018-04.

REASON: These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray.

MANUFACTURER: Surgical Specialties Corp., Reading, PA, by fax on August 21, 2003 and by letter on August 22, 2003. Firm initiated recall is ongoing.

PRODUCT: Sharpoint 2.75 mm x 3.75 mm Clear Trap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives. Recall # Z-0026-04.

REASON: The text on product handle is incorrect.

MANUFACTURER: Dow Corning Corp, Hemlock, MI, by telephone and by letter dated September 5, 2003. Firm initiated recall is ongoing.

PRODUCT: Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes). Recall # Z-0029-04.

REASON: The product maybe contaminated with iron, chromium and nickel from stainless steel equipment failure during manufacture.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on September 8, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Coulter AcT 5diff Open Vial Hematology Analyzers, Part Numbers: 6605580, 6605581, 6605604. Recall # Z-0039-04;
b) Coulter AcT 5diff Cap Pierce Hematology Analyzers, Part Numbers: 6605641, 6605705. Recall # Z-0040-04.

REASON: Samples with high fat content will not count platelets accurately.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Issaquah, WA, by letter on September 5, 2003. Firm initiated recall is ongoing.

PRODUCT: SONOLINE Antares Diagnostic Ultrasound System. Catalog No. 5936518, 7035415, 5936682, 5936682, 5936708, 5936716, 5936724. Recall # Z0041-04.

REASON: Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.

MANUFACTURER: Ortho Development Corporation, Draper, UT, by telephone, and letters on September 15, 2003. Firm initiated recall is ongoing

PRODUCT: Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System. Part # 252-0300. Recall # Z-0042-04.

REASON: The guide pin, which rotationally constrains the tibial punch within the punch guide, has fallen out on several parts of the Balanced Knee System.

MANUFACTURER: Vasca, Inc., Tewksbury, MA, by letter on September 22, 2003. Firm initiated recall is ongoing.

PRODUCT: LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000. Recall Z-0045-04.

REASON: Outer kit mislabeled with an extended expiration date.

MANUFACTURER: Wilson-Cook Medical Inc., Winston-Salem, NC, by email on October 8, 2003. Firm initiated recall is ongoing.

PRODUCT: Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports: 10, Standard wire Guide: .035"/480 cm. Disposable - Single use only, Rx Only. Catalog # CDSB-10. Recall # Z-0048-04.

REASON: Product may be packaged with an incorrect instructions for use (IFU) booklet.

MANUFACTURER: Medtronic Neurosurgery, Goleta, CA, by hand delivery on September 15, 2003. FDA initiated recall is complete.

PRODUCT:
a) Channel Neuroendoscope, Standard Resolution, 21.6 cm. Catalog No. 2232-001. Recall # Z-0049-04;
b) Channel Neuroendoscope, Standard Resolution, 13 cm. Catalog No. 2232-003. Recall # Z-0050-04.

REASON: Size mix-up. 13cm product may be labeled as 21.6 mm and visaversa.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 22, 2003:

CLASS II

MANUFACTURER: Bard Peripheral Vascular, Tempe, AZ, by telephone on August 20, 2003. Firm initiated recall is complete.

PRODUCT: Opti-Plast Balloon Dilatation Catheters. Recall # Z-0002-04.

REASON: Product intended for distribution outside USA was distributed without pre-market notification requirements being met.

MANUFACTURER: Rultract Inc., Independence, OH, by letter on September 18, 2003. Firm initiated recall is ongoing.

PRODUCT: Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. Recall # Z-0008-04.

REASON: Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure.

MANUFACTURER: Siemens Medical Solutions USA, Inc, Malvern, PA, by Service Engineer visit, beginning on August 8, 2003. Firm initiated recall is ongoing.

PRODUCT: Urology X-Ray System, Hardware for Motor Drive. Recall # Z-0009-04.

REASON: Possible movement of table tilt and table longitudinal.

MANUFACTURER: Bard Peripheral Vascular, Tempe, AZ, by letter dated September 17, 2003. Firm initiated recall is ongoing.

PRODUCT: Conquest Ballon Dilation Catheters Model/Catalog Number CQ 75124. Recall # Z-0010-04.

REASON: Mislabeled. 7mm balloon labeled 12mm.

MANUFACTURER: GE Medical Systems Information Technologies, Tampa, FL, by letter beginning on April 30, 2003 until August 14, 2003. Firm initiated recall is ongoing.

PRODUCT: Power cord manufactured by ElectriCord Manufacturing Company, P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug. Recall # Z-0011-04.

REASON: Reports of broken plug ground pins on AC power cords for patient monitors.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letter on or about May 12, 2003. Firm initiated recall is complete.

PRODUCT: Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156. Recall # Z-0012-04.

REASON: Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the RI reagent is depleted.

MANUFACTURER: GE Medical Systems Information Technologies, Tampa, Fl, by letter on November 16, 2000. Firm initiated recall is complete.

PRODUCT:
a) Critikon brand Omni-Stat Finger Sensor - P/N 009084. Recall # Z-0013-04;
b) Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130. Recall # Z-0014-04;
c) Critikon brand Omni-Sat Adult, Semi-Disposable Sensor - P/N 009136. Recall # Z-0015-04.

REASON: Instructions for use contained incorrect sensor reference.

MANUFACTURER: Plus Endoprothetik AG, Rotkreuz, China, by letter and telephone on May 16, 2003, June 2, 2003 and August 26, 2003. FDA initiated recall is complete.

PRODUCT: TC-PLUS Solution Tibial Component-Symmetric. Recall # Z-0017-04.

REASON: Labeling/packaging mix-up.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on August 18, 2002. Firm initiated recall is ongoing.

PRODUCT: CryoValve, Pulmonary Valve & Conduit SG. Recall # Z-0019-04.

REASON: The heart valve procurement exceeded the warm ischemic time criteria.

MANUFACTURER: Vital Concepts, Inc., Grand Rapids, MI, by letter beginning on July 11, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Recall # Z-0020-04;
b) Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec. Recall # Z-0021-04;
c) HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Recall # Z0022-04;
d) HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R. Recall # Z-0023-04;
e) Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Recall # Z-0024-04;
f) Irrigation Aspiration System for Nezhat Dorsey Type Pumps with 33 cm Probe, and Tubing, Disposable (single use only), sterile, latex free. Catalog # 55050. Recall # Z-0025-04.

REASON: The suction valve may become stuck in the 'suction on' position under vacuum.

MANUFACTURER: Instrumentation Laboratory Co., Lexington, MA, by telephone on August 28, 2003. Firm initiated recall is ongoing.

PRODUCT: Lactate Disposable Membrane Caps Product Number: 0018108400. Recall # Z-0027-04.

REASON: Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L.

MANUFACTURER: Roche Diagnostics Corp, Indianapolis, IN, by letters on September 2, 2003 and September 18, 2003. Firm initiated recall is ongoing.

PRODUCT: Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837. Recall # Z-0028-04.

REASON: Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician.

MANUFACTURER: Boston Scientific Scimed, Maple Grove, MN, by letter dated August 20, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011. Recall # Z-0030-04;
b) Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051. Recall # Z-0031-04;
c) Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1cm Tip 20 mm Balloon, Catalog Number H74903628151. Recall # Z-0032-04.

REASON: Some of the recalled catheters have a component that has levels of pyrogens above specification.

MANUFACTURER: VIASYS Med Systems, Wheeling, IL, by telephone and fax on September 10 and 11, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; 20 units per case; reorder #BLD-83124-2. Recall # Z-0033-4;
b) Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; 20 units per case; reorder #BLD-83100-24. Recall # Z-0034-04;
c) Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; 20 units per case; reorder #BLD-83144-24. Recall # Z-0035-04;
d) Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; 20 units per case; reorder #BLD-83120. Recall # Z-0036-04;
e) Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; 20 units per case; reorder #BLD- 83166. Recall # Z-0037-04; f) Sideport Kit w/Oxygen Line, consisting of an adjustable sideport valve, an O2 port elbow and O2 supply tubing; 20 units per case; reorder #BLD-83167. Recall # Z-0038-04.

REASON: The exhalation hole in the side-port relief valve may be blocked, allowing excess pressure build-up.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA., by letter on August 26, 2003. Firm initiated recall is ongoing.

PRODUCT: Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent. Recall # Z-0046-04.

REASON: Package insert contains inaccurate information.

MANUFACTURER: Olympus America Inc., Melville, NY, by letters dated August 19, 2003. Firm initiated recall is ongoing.

PRODUCT: Olympus ImageManager Software, Common name: Medical image storage device {NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking.) Recall # Z-0047-04.

REASON: Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.

CLASS III

MANUFACTURER: Stryker Howmedica Osteonics, Mahwah, NJ, by letters on August 4, 2003. Firm initiated recall is complete.

PRODUCT: T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S. Recall # Z-1295-03.

REASON: The device does not have an oblong hole for dynamic locking as required.

MANUFACTURER: Liberty Medical Supplies, Port Saint Lucie, FL, by letter on February 25, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Liberty brand Insulin Syringes for use with U-100 insulin, ‡ cc X 30G X 5/16" syringes. Recall # Z-0003-04;
b) Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X ‡" insulin syringes. Recall # Z-0004-04;
c) Liberty brand Insulin Syringes for use with U-100 insulin, ‡ cc X 29G X ‡" insulin syringes. Recall # Z-0005-04

REASON: The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box.

MANUFACTURER: Inamed Corp, Goleta, CA, by letter on September 12, 2003. Firm initiated recall is ongoing.

PRODUCT: McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401, 25-40461, 25-40501, 25-40561. Recall # Z-0006-04

REASON: The 400cc, 460cc, 500cc 560cc sizes of the McGhan Style 40 Silicone-filled Breast Implants were manufactured using one size smaller shells that required.

MANUFACTURER: Smith and Nephew, Inc., Wound Management Division, Largo, FL, by letter on April 15, 2003. Firm initiated recall is complete.

PRODUCT: Acticoat* Moisture Control Dressing, Product Code 20211. Recall # Z-0016-04.

REASON: Product may not meet the established stability specification before the end of labeled expiry date.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 15, 2003:

CLASS II

MANUFACTURER: Becton Dickinson & Co., Sparks, MD, by letter on August 11, 2003. Firm initiated recall is ongoing.

PRODUCT: BBL ™ LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266. Recall # Z-1294-03.

REASON: Broth for growing selective bacteria may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate Group B Streptococci.

MANUFACTURER: Cryolife Inc., Kennesaw, GA, by letter on September 10, 2003 and September 12, 2003. Firm initiated recall is ongoing.
PRODUCT:
a) CryoValve, Aortic & Conduit. Donor #69884, Model #AV00. Recall # Z-1996-03;
b) CryoValve, Pulmonary Valve & Conduit. Donor #69884, Model #PV00.Recall # Z-1997-03.

REASON: Firm received additional information from the procurement agency indicating that the donor’s serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results.

CLASS III

MANUFACTURER: DPC Cirrus, Flanders, NJ, by Recall Technical Bulletins on June 13, 2003. Firm initiated recall is complete.

PRODUCT: Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software. Recall # Z-1138-03.

REASON: Version 2.6 software was released however, it will not properly handle adjustment slopes.

MANUFACTURER: PerkinElmer Life Sciences Inc., Norton, OH, by telephone and fax on June 27, 2003 and July 1, 2003. Firm initiated recall is ongoing.

PRODUCT: Neonatal GALT Test Kit, 4800 assays per kit, catalog No. NG-4100. Recall # Z-1139-03.

REASON: The kits are producing lower values than expected, which may result in an increase of false positive test results.

MANUFACTURER: Perkinelmer Life Sciences, Inc., Boston, MA, by telephone on July 21, 2003 and by letter on July 25, 2003. Firm initiated recall is ongoing.

PRODUCT: Anti-dsDNA (1251) Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103. Recall # Z-1140-03.

REASON: Product’s outer carton label was labeled with an extended expiration date.

MANUFACTURER: Varian, Inc., Lake Forest, CA, by letter on July 18, 2003. Firm initiated recall is ongoing

PRODUCT: On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. Catalog numbers: 47464, Roche Diagnostics Label A305-02 Varian, Inc. label. Recall # Z-1202-03.

REASON: Stability in question.

MANUFACTURER: Rxachech, Inc., Gainesville, FL, by letter dated July 31, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Exactech Tibial Augmentation Block Trial Size 0, Tibial Augment block Trial, Catalog # 205-60-05, Tibial Augment Block Trial, Catalog # 205-60-08;
b) Exactech Tibial Tray Trial size 1 Delta, Catalog # 201-70-81;
c) Exactech Trapezoid Tray Trial size 1 Delta, Catalog # 205-70-81. Recall # Z-1211-03.

REASON: Misalignment of the fixation holes between the tibial augment block trials and the corresponding tibial tray trials and trapezoid tray trials. The misalignment of the pin fixation holes only creates an issue when augmentation is used.

MANUFACTURER: Chattanooga Corp., Hixson, TN, by telephone and email on May 30, 2003. Firm initiated recall is ongoing.

PRODUCT: Triton MP-1 Traction Unit. Model/Catalogue Nos.: 7961 (120 Volt) and 7963 (220 Volt). Recall # Z-1215-03.

REASON: Product contains an improper bracket for the transducer.

MANUFACTURER: Inamed Corp, Goleta, CA, by telephone on August 1, 2003. Firm initiated recall is complete.

PRODUCT: McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Brest Implant Saline Filled BIOCELL textured. Recall # Z-1216-03.

REASON: Labeling mix-up.

MANUFACTURER: Diagnostic Products Corp., Los Angeles, CA, by fax on July 31, 2003. Firm initiated recall is ongoing.

PRODUCT: Immulite 2000 H. pylori IgG Kit (L2KHQ6, 600 test size kit). Recall # Z-1219-03.

REASON: Kits had parts in them that did not belong in the kit.

MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated between July 28, 2003 and August 11, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** (NOTE: product has an 18 month shelf life.) Recall # Z-1224-03;
b) Vitros Chemistry***GLU (glucose) DT Slides per box***CAT 1532316*** (NOTE: product has a 24-month shelf life.) Recall # Z-1225-03.

REASON: Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator. GLU slides are processed by high volume chemistry systems typically used in hospital laboratories.

MANUFACTURER: Ciba Vision Corp, Duluth, GA, by letter on August 13, 2003. Firm initiated recall is ongoing.

PRODUCT: Quick Care Starting Solution. The product is used for cleaning and disinfection of soft (hydrophilic) contact lenses. Recall # Z-1234-03.

REASON: Investigation has determined that the concentration of the isopropyl alcohol (IPA) decreased over time and may fall below specifications prior to reaching the expiration date.

MANUFACTURER: GE Medical Systems Information Technologies, Tampa, FL, by letter and telephone on October 24, 2000. Firm initiated recall is complete.

PRODUCT: Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor. Recall # Z-1236-03.

REASON: Incorrect male connector attached to tubing preventing the correct connection of blood pressure cuff.

MANUFACTURER: GE Medical Systems Information Technologies, Tampa, FL, by telephone and letter on March 7, 2001. Firm initiated recall is complete.

PRODUCT: Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930, labeled in part: ***Reusable Blood Pressure Cuffs Infant 50 Cuffs REF 008-0625-00, Assembled in Mexico***. Recall # Z-1237-03.

REASON: Wrong connector attached to blood pressure cuff.

MANUFACTURER: BioMerieux, Durham, NC, by letter on July 31, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Simplastin® L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553. Recall # Z-1238-03;
b) MDA® Simplastin® L, Product number 252555, 10 vials, 40 ml ea (400 test each). Recall # Z-1239-03.

REASON: Complaints of prolonged clot times.

MANUFACTURER: Wilson-Cook Medical Inc., Winston-Salem, NC, by letter on September 15, 2003. Form initiated recall is ongoing.

PRODUCT: Quantum TTC Biliary Ballon Dilator. Recall # Z-1292-03.

REASON: The product was labeled ‘esophageal’, but contained a ‘biliary’ ballon.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 8, 2003:

CLASS I

MANUFACTURER: BioMerieux, Durham, NC, by letter on August 6, 2003. Firm initiated recall is ongoing.

PRODUCT: VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number 30101. Recall # Z-1209-03.

REASON: Product's decrease in sensitivity may result in false negative results.

CLASS II

MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, by letter dated July 16, 2003. FDA initiated recall is ongoing.

PRODUCT:
a) Disetronic H-TRON V100 Insulin Pump, catalog # 8010030C (clear case) and 8010030 (solid-color case). Recall # Z-1196-03;
b) Disetronic H-TRONplus Insulin Pump, catalog # 8050023
(clear case), 8050064 (blue case), 8050021 (solid-color case) and 8050071 (yellow case). Recall # Z-1197-0.

REASON: Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.

MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, by letter dated July 24, 2003. FDA initiated recall is ongoing.

PRODUCT: Disetronic D-TRONplus Insulin Pump. Recall # Z-1198-03.

REASON: Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod.

MANUFACTURER: Bard Endoscopic Technologies, Billerica, MA, by Recall Notice on August 4, 2003. Firm initiated recall is ongoing

PRODUCT:
a) Bard PEG Safety System "Guidewire" Reorder Number 000930. Recall # Z-1230-03;
b) Bard Ponsky PEG Safety System "Pull" Reorder Number 001925. Recall # Z-1231-03;
c) Bard Ponsky PEG Safety System "Pull" Reorder Number 001927. Recall # Z-1232-03;
d) Bard PEG Safety System "Guidewire" Reorder Number 001928. Recall # Z-1233-03.

REASON: Mislabeled kit: Prefilled Lidocaine syringe is labeled "sterile fluid path only", outer label states kit content is sterile.

MANUFACTURER: Blue Torch Medical Technologies, Ashland, MA, by fax on July 10, 2003. Firm initiated recall is complete.

PRODUCT: CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile Part Number: 8305. Recall # Z-1235-03.

REASON: Products sterility is compromised due to a failed sterility audit.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on July 23, 2003. Firm initiated recall is ongoing.

PRODUCT: Calculator/Data Processing Module for Clinical Use.
Recall # Z-1240-03.

REASON: Software Defect.

MANUFACTURER: The Anspach Effort, Inc., Palm Beach Gardens, FL., by letter and fax on April 23, 2003. Firm initiated recall is complete.

PRODUCT: Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill motor, foot-pedal control, motor attachments or drills/burrs).
Recall # Z-1243-03

REASON: Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letter dated 8/5/03. FDA initiated recall is ongoing

PRODUCT: Disetronic Dahedi insulin infusion pump; catalog # 8500019. Recall # Z-1244-03.

REASON: Lack of assurance of reliability.

MANUFACTURER: MedSurg Solutions, Plymouth, MN. FDA initiated recall is ongoing. Recalling Firm: International Surgical Supply, Inc., Miami, FL, by e-mail on September 3, 2003.

PRODUCT:
a) ETHICON brand surgical device. The product described on label is a Stapler, reload, TR35W, TR776, TCR 75, TCR 55, TRT75. Recall #Z-1257-03;
b) ETHICON brand surgical device. The product described on label is a: 5mm Curved Shears, Scissors Grip Handle 14cm Item Code CS14C. Recall # Z-1258-03;
c) ETHICON brand surgical device. The product described on label is a: Reloads for Devices EZ45, ET45, NK45 Thick Tissue, item ZR45G. Recall # Z-1259-03;
d) ETHICON brand surgical device. The product described on label is a: Linear Cutter, Thick tissue 75 mm, item code TCT75. Recall # Z-1260-03;
e) ETHICON brand surgical device. The product described on label is a: Cutter, Linear 55mm and 75mm, item numbers TCT75 and TLC55. Recall # Z-1261-03;
f) ETHICON brand surgical device The product described on label is a: Laparosonic coagulating curved Pistal grip 5 mm, curved, Item Number LCSC5. Recall # Z-1262-03;
g) ETHICON brand surgical device. The product described on label is a: Blade, 5 mm Curved Harmonic, item HC325. Recall # Z-1263-03;
h) ETHICON brand surgical device. The product described on label is a: Stapler EMS Endo Hernia , item # 8034. Recall # Z-1264-03;
i) ETHICON brand surgical device. The product described on label is a: TX Stapler, Reloadable, Linear 30 mm and 60 mm, item numbers TX30 and TX60. Recall # Z-1265-03;
j) ETHICON brand surgical device. The product described on label is a: Stapler, Posered LDS Single Use, item # 092001. Recall # Z-1266-03;
k) ETHICON brand surgical device The product described on label is a: Stapler, Articulating, Linear, item # AX55.Recall # Z-1267-03;
l) ETHICON brand surgical device The product described on
label is a: Trocar, Dilating Tip, 10/12 mm, 100 length
w/stability sleeve, Item # 512SD. Recall # Z-1268-03;
m) ETHICON brand surgical device. The product described on label is a: Trocar, Tristar, blunt tip, item 512B. Recall # Z-Z-1369-03;
n) ETHICON brand surgical device. The product described on label is a: Scissors, curved with unipola 5 mm. Recall # Z-1370-03;
o) ETHICON brand surgical device The product described on label is a: Shears, Coagulating, item CS150. Recall # Z-1271-03;
p) ETHICON brand surgical device. The product described on label is a: Cutter, ETS Endoscopic Linear, 35 mm, item # TSB 35. Recall # Z-1272-03;
q) ETHICON brand surgical device. The product described on label is a: Clip Applier, Multiple MCA, 20 clips 9 3/8 inch, item # MCS 20. Recall #Z-1273-03;
r) ETHICON brand surgical device. The product described on label is a: Hook, Dissecting Harmonic Scalpel Blade 10 cm., item # DH105. Recall # Z-1274-03;
s) ETHICON brand surgical device The product described on label is a: Needle, 120 mm, Pneumopcritoneum, item # PN120. Recall # Z-1275-03;
t) ETHICON brand surgical device. The product described on label is a: Thoracic Trocar Sleeve, rounded tip, Item # TT012. Recall #Z-1276-03;
u) ETHICON brand surgical device. The product described on label is a: Cutter, Linear Vascular, Item # TSB-35. Recall # Z-1277-03;
v) ETHICON brand surgical device. The product described on label is a: Needle, Ultra Veress. Recall # Z-1278-03.

REASON: Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.

MANUFACTURER: Bausch & Lomb, Incorporated, Lynchburg, VA, by telephone and letter on August 25, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part ***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box. Recall # Z-1279-03;
b) Phaco Needles, catalog #DP8115, with 15 degree needle taper, labeld in part***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6
needles/box. Recall # Z-1280-03.

REASON: The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter on June 18, 2003. Firm initiated recall is complete.

PRODUCT:
a) Stanmore modular hip system; Stanmore CoCr femoral size1 std. Stem; part 164241. Recall # Z-1281-03;
b) Stanmore modular hip system; Stanmore CoCr femoral size 2 std. stem; part 164242. Recall # Z-1282-03;
c) Stanmore modular hip system; Stanmore CoCr femoral size 3 std. stem; part 164243. Recall # Z-1283-03;
d) Stanmore modular hip system; Stanmore CoCr femoral size 4 std. stem; part 164244. Recall # Z-1284-03;
e) Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245. Recall # Z-1285-03;
f) Stanmore modular hip system; Stanmore CoCr femoral size 1 straight stem; part 164251. Recall # Z-1286-03;
g) Stanmore modular hip system; Stanmore CoCr femoral size 2 straight stem; part 164252. Recall # Z-1287-03;
h) Stanmore modular hip system; Stanmore CoCr femoral size 3 straight stem; part 164253.Recall # Z-1288-03;
i) Stanmore modular hip system; Stanmore CoCr femoral size 4 straight stem; part 164254. Recall # Z-1289-03;
j) Stanmore modular hip system; Stanmore CoCr femoral size 5 straight stem; part 164255. Recall # Z-1290-03.

REASON: The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.

MANUFACTURER: GE Medical Systems Information Technologies, Tampa, FL, by letter and telephone on May 14, 2003. Firm initiated recall is ongoing.

PRODUCT: GE Medical Systems Corometrics Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is.
Recall # Z-1291-03.

REASON: The 2120 Main Board on device lacks required external safety "watchdog" circuit.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 24, 2003:

CLASS II

MANUFACTURER: Wright Medical Technology, Inc., Arlington, TN, by memo notification to distributors on May 8, 2003 and by letter to implanting physicians on August 18, 2003. FDA initiated recall is ongoing.

PRODUCT: Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system. Recall # Z-1186-3.

REASON: Wright Medical commercially distributed Transcend alumina acetabular shell liners lacking the required process validation.

MANUFACTURER: Becton Dickinson & Company, Franklin Lakes, NJ, by letter on July 23, 2003. Firm initiated recall is ongoing.

PRODUCT: BD Blood Glucose Test strips. BD Latitude, 100 Test Strips 100 Bandelettes Reactives, Manufactured for BD by Nova Biomedical Corp, Waltham, MA, Distributed by Becton Dickinson Canada, Inc., Oakville, ON. Recall # Z-1221-03.

REASON: Test strips may not be meeting specifications at the lower range of glucose values.

MANUFACTURER: Abiomed, Inc., Danvers, MA, by letter on August 19, 2003. Firm initiated recall is ongoing.

PRODUCT: BVS 5000t Bi-Ventricular Support System Transport/Backup Console. Catalog Number 0050-000. Recall # Z-1222-03.

REASON: Bi-Ventricular support system may switch to battery when primary voltage (AC) is available.

MANUFACTURER: Philips Medical Systems, Andover, MA, by letter on September 2, 2003. Firm initiated recall is ongoing.

PRODUCT: HeartStart XL Defibrillator Monitor. Model M4735A. Recall # Z-1226-03.

REASON: Instructions for use include additional information on configuration for selecting Power on Lead.

MANUFACTURER: Philips Medical Systems, Bothell, WA, by Field Change Orders on November 21, 2002. Firm initiated recall is complete.

PRODUCT: a) Gyroscan ACS-NT with software versions R6x, R7x, R8x. Recall # Z-1227-03;b) Gyroscan NT-Intera. Recall # Z-1228-03;c) Gyroscan Intera 1.0T & 1.5T. Recall # Z-1229-03.

REASON: Patient burns from cables near or in contact with the patient during use.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 17, 2003:

CLASS II

MANUFACTURER: Philips Medical Systems, Bothell, WA, by letter on February 13, 2002. Firm initiated recall is complete.

PRODUCT: Easy Access PACS System with software. Recall # Z-471-3.

REASON: Potential display of an incorrect body part description on patient images.

MANUFACTURER: Datex-Ohmeda, Inc., Madison, WI, by letters dated July 15, 2003. Firm initiated recall is ongoing.

PRODUCT: Datex-Ohmeda S/5 Anesthesia Delivery Units. Recall # Z-937-3.

REASON: Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.

MANUFACTURER: Abbott Vascular Devices, Redwood City, CA, by letters on July 21, 2003. Firm initiated recall is complete.

PRODUCT: BiodivYsio? SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; a) Catalog # B3225-10; b) Catalog # B3225-10; c) Catalog # B3225-15; d) Catalog # B3225-18. Recall # Z-1141-03.

REASON: The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by telephone on February 4, 2002. Firm initiated recall is complete.

PRODUCT: CryoValve Heart-valve, allograft. Recall # Z-1187-03.

REASON: Donor of aortic valve had procurement cultures that were positive for E-coli.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter starting April, 2003. Firm initiated recall is ongoing.

PRODUCT: CryoValve Heart Valve. Recall # Z-1188-03.

REASON: CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors.

MANUFACTURER: Boston Scientific Scimed, Maple Grove, MN, by letter dated August 1, 2003. Firm initiated recall is ongoing.

PRODUCT: Boston Scientific Medi-Tech Imager II 5F Selective Angiographic Catheter. Recall # Z-1189-03.

REASON: Some of the recalled catheters may be in pouches with incomplete seals.

MANUFACTURER: Terumo Cardiovascular Systems, Corp, Ann Arbor, MI, by letters on August 8, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 4428. Recall # Z-1190-03;b) Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, malleable stylet, ribbed balloon, manual-inflate. Catalog # 4430. Recall # Z-1191-03;c) Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 5578. Recall # Z-1192-03;d) Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, malleable stylet, ribbed balloon, manual-inflate. Catalog # 5579. Recall # Z-1193-03;e) Sarns brand Retrograde Cardioplegia Cannula, 15 Fr, guidewire stylet, smooth balloon, manual-inflate. Catalog # 7270. Recall # Z-1194-03;Sarns brand Retrograde Cardioplegia Cannula, 15 Fr, guidewire stylet, ribbed balloon, manual-inflate. Catalog # 7272. Recall # Z-1195-03.

REASON: Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.

MANUFACTURER: Perkinelmer Life Sciences, Inc., Boston, MA, by telephone on July 23, 2003 and by letter dated July 25, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Angiotensin I (1251) Radioimmunoassay Kit, 250 Tube,Catalog Number: NEA104 For in-vitro diagnostic use.Recall # Z-1206-03;b) Angiotensin I (1251) Radioimmunoassay Kit, 500 Tube,Catalog Number: NEA105, for in-vitro diagnostic use.Recall # Z-1207-03.

REASON: Perkinelmer Life Sciences, Inc., Boston, MA, by telephone on July 23, 2003 and by letter dated July 25, 2003. Firm initiated recall is ongoing.

MANUFACTURER: Harvard Clinical Technology, South Natick, MA, by letter on August 11, 2003. Firm initiated recall is ongoing.

PRODUCT: Harvard 2, Dual Infusion Pump (P/N 2002-001). Recall # Z-1208-03.

REASON: Under specific sequence conditions, the unit may appear to be infusing, but is not.

MANUFACTURER: Chattanooga, Corp, Hixson, TN, by telephone on May 30, 2003. Firm initiated recall is ongoing.

PRODUCT: Triton T-700 Traction Unit. Model/Catalogue Nos: 7950 (120 Volt) and 7952 (220 Volt). Recall # Z-1210-03.

REASON: Product contains an improper bracket for the transducer.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on July 22, 2003. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory System. Recall # Z-1217-03.

REASON: Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported.

MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letters dated August 22, 2003. Firm initiated recall is ongoing.

PRODUCT: AxSYM Homocysteine Reagent Pack, list 5F51-20. Recall # Z-1218-03.

REASON: There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ by facsimile on July 24, 2003. Firm initiated recall is ongoing.

PRODUCT: Calculator/Data Processing Module for Clinical Use. Recall # Z-1220-03.

REASON: Software Design Defect. Under certain conditions, results are removed.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 10, 2003:

CLASS I

MANUFACTURER: Becton Dickinson & Co., Sparks, MD, by letter on July 21, 2003. Firm initiated recall is ongoing.

PRODUCT: Becton Dickinson's ProbeTec ( ET Instrument. Recall # Z-1094-03.

REASON: Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.

CLASS II

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by telephone beginning on February 25, 2003, and letter dated February 27, 2003. Firm initiated recall is complete.

PRODUCT: Sarns MP4 Cardioplegia Sets; catalog number 15501. Recall # Z-0664-3.

REASON: There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.

MANUFACTURER: Watson Diagnostics, Inc., Corona, CA., by letter on August 7, 2003. Firm initiated recall is ongoing.

PRODUCT: Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box. Recall # Z-0977-03.

REASON: Lights split, spilling contents when bent to activate.

MANUFACTURER: Stryker Howmedica Osteonics, Mahwah, NJ, by letters on July 17, 2003. Firm initiated recall is ongoing.

PRODUCT: Femoral Resection Guide, Scorpio L.R.S. Instrumentation. Recall # Z-1143-03.

REASON: Scorpio Femoral Resection Guides have the potential to remove more bone than necessary.

MANUFACTURER: Hill-Rom Co, Inc., Batesville, IN, by letter dated August 8, 2003. Firm initiated recall is ongoing.

PRODUCT: Integris Monitor Arm; model P997-04. Recall # Z-1145-03.

REASON: The monitor may separate from the monitor arm, allowing the monitor to fall from the arm.

MANUFACTURER: Exactech, Inc., Gainesville, FL., by letters dated July 30, 2003. Firm initiated recall is ongoing.

PRODUCT: Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5). Recall # Z-1146-03.

REASON: The alpha and beta markings on the offset tibial bushings are in a location that would lead to the improper selection of an offset tibial tray.

MANUFACTURER: Baxter Healthcare, Corp., Round Lake, IL, by letter dated July 16, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Baxter Solution Set, 10 drops/mL, 101", Male LuerLock Adapter, catalog 1C8109; Baxter Healthcare Corporation, Deerfield, IL, USA. Recall # Z-1150-03;
b) Interlink System Solution Set with Microbore Tubing, 60 Drops/mL, 123", 2 injection sites, Male Luer Lock Adapter, catalog 2C6426; Baxter Healthcare Corporation, Deerfield, IL, USA. Recall # Z-1151-03;
c) Interlink System Continu-Flo Solution Set with Microbore Tubing, 60 drops/mL, 128", 3 injection sites, Male LuerLock Adapter, catalog 2C6521; Baxter HealthcareCorporation, Deerfield, IL, USA. Recall # Z-1152-03;
d) Continu-Flo Solution Set, 10 drops/mL, 104", 0.22 Micron Downstream High Pressure Extended Life Filter, 3 Injection Sites, Male Luer Lock Adapter, catalog 2C6593; Baxter Healthcare Corporation, Deerfield, IL, USA. Recall # Z-1153-03;
e) Interlink System Vented Nitroglycerin Set, 104", PVCTubing Segment, Injection Site, Male Luer Lock Adapter, catalog 2C7551; Baxter Healthcare Corporation, Deerfield, IL, USA. Recall # Z-1154-03;
f) Baxter Vented Nitroglycerin Set, 105", PVC Tubing Segment, Injeciton Site, Male Luer Lock Adapter, catalog2C7552; Baxter Healthcare Corporation, Deerfield, IL, USA. Recall # Z-1155-03;
g) Clearlink System Continu-Flo Solution Set, 10 drops/mL, 113", 2 Luer Activated Valves, Male Luer Lock Adapter, catalog 2C8519; Baxter Healthcare Corporation, Deerfield, IL, USA. Recall # Z-1156-03;
h) Clearlink System Nitroglycerin Set with DUO-VENT Spike, 60 drops/mL, 105", PVC Tubing Segment, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8851; Baxter Healthcare Corporation, Deerfield, IL, USA. Recall # Z-1157-03;
 i) Clearlink System Vented Paclitaxel Set, 10 drops/mL,111", Polyethylene Lined Tubing, Non-DEHP Pump Segment, 0.22 Micron Extended Life Filter, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8857; Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1158-03;
j) Continu-Flo Solution Set, 60 drops/mL, 106", 3 Luer Activated Valves, Male Luer Lock Adapter, catalog 2C9906; Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1159-03;
k) Baxter Y-Type Blood/Solution Set, 10 drops/mL, 112", Standard Blood Filter, 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C6750; Baxter Healthcare Corporation, Deerfield, IL, USA. Recall # Z-1160-03;
l) Clearlink System Y-Type Blood/Solution Set, 10 drops/mL, 112", Standard Blood Filter, 170 to 260 Micron Filter, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8750; Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1161-03;
m) Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter and Pressure Pump, 15 drops/mL, 99", 170 to 260 Micro Filter, Large Standard Blood Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 4C6723; Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1162-03;
n) Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 89", 170 to 260 Micron Filter, Large Bore Tubing, Male Luer Lock Adapter, catalog 4C7776A; Baxter Healthcare Corp., Deerfield, IL. Recall # Z-1163-03;
o) Colleague Pump Syringe Adapter Set, 92", Injection Site, Non-DEHP Tubing, Luer Lock Adapters, catalog 2C0169; Baxter Healthcare Corp, Deerfield, IL. Recall # 1164-03;
p) Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99", 170 to 260 Micron Filter, Large Standard Blood Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 2C6723; Baxter Healthcare Corp., Deerfield, IL.Recall # Z-1165-03;
q) Baxter Solution Set, 10 drops/mL, 76", Luer Activated Valve, Male Luer Lock Adapter, catalog 2C9901; Baxter Healthcare Corp., Deerfield, IL. Recall # Z-1166-03;
r) Baxter Solution Set, 60 drops/mL, 76", Luer Activated Valve, Male Luer Lock Adapter, catalog 2C9902; Baxter Healthcare Corp., Deerfield, IL. Recall # Z-1167-03;
s) Vented Solution Set, 10 drops/mL, 92", Luer Activated Valve, Male Luer Lock Adapter, catalog 2C9903; Baxter Healthcare Corp., Deerfield, IL. Recall # Z-1168-03;
t) Continu-Flo Solution Set, 10 drops/mL, 110", 3 LuerActivated Valves, Male Luer Lock Adapter, catalog 2C9905; Baxter Healthcare Corporation, Deerfield, IL.Recall # Z-1169-03;
u) Continu-Flo Solution Set, 10 drops/mL, 113", 2 Luer Activated Valves, Male Luer Lock Adapter, catalog 2C9907; Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1070-03;
v) Baxter Y-Type Blood/Solution Set, 10 drops/mL, 115", 80 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C7617; Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1171-03;
w) Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99", Large Standard Blood Filter, 170 to 260 Micron Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 2C7623; Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1172-03.
x) Fenwal Blood Component Recipient Set with Standard Blood Filter, 10 drops/mL, 55", 170 to 260 Micron Filter, catalog 4C2100; Baxter Healthcare Corporation, Deerfield, IL. Recall # Z- 1173-03.
y) Fenwal Y-Type Blood Component Recipient Set with Standard Blood Filter, 10 drops/mL, 65'', 170 to 260 Micron Filter, catalog 4C2196; Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1174-03;
z) Fenwal Straight Type Blood Set with Large Standard Blood filter, 15 drops/mL, 80'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 4C6766;Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1175-03;
aa) Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 107", 2 Injection Sites, Male Luer Lock Adapter, catalog 4C7774; Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1176-03;
bb) Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 10 drops/mL, 82", 170 to 260 Micron Filter, Large Bore Tubing, Male Luer Lock Adapter, catalog 4C7776; Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1177-03.

REASON: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process

MANUFACTURER: Wilson-Cook Medical Inc., Winston-Salem, NC, by letter on August 8, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Spiral Z Expandable Metal Biliary Stent. Recall # Z-1179-03; b) Za-Stent Expandable Metal Biliary Stent. Recall # Z-1180-03; c) Zilver Expandable Metal Biliary Stent. Recall # Z-1181-03.

REASON: The inner catheter of the introducer system may break after stent deployment.

MANUFACTURER: U & I America, Murray, UT, by letter on August 18, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Optima Poly Screw Driver, Part OP20002 Revision C. Recall # Z-1182-03; b) Optima Large Poly Screw Driver, Part OP20012 Revision B. Recall # Z-1183-03.

REASON: Reports of pieces chipping off the tip of screwdriver during use.

MANUFACTURER: Conmed Corporation, Utica, NY, by letters dated July 30, 2003. Firm initiated recall is ongoing.

PRODUCT: a) 1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as:
1) Cat No 1680-001 (1 unit per pouch/30 per box);
2) Cat No 1680-003 (3 units per pouch/30 per box);
3) Cat No 1680-005 (5 units per pouch/50 per box); and
4) Cat No 1680-030 (30 units per pouch/no box). The electrodes are packaged 600 units/case. Recall # 1184-03;
b) 1690 Ultratrace Series ECG Electrodes, clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1690-001 (1 unit per pouch/30 per box); Cat No 1690-003 (3 units per pouch/30 per box); Cat No 1690-005 (5 units per pouch/50 per box); Cat No 1690-010 (50 units per pouch/no box/ 1000 per case); Cat No 1690-030 (30 units per pouch/no box). The above are sold in boxes of 600 with the exception of 1690-010 (sold 1000 per case) as noted above. Recall # Z-1185-03.

REASON: Separation of the sensing element from the body of the electrode.

CLASS III

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter dated December 29, 2000. Firm initiated recall is complete

PRODUCT: Abbott Aeroset System list number 9D05-01. Recall # Z-1142-03.

REASON: ICT assays run using a manual dilution will not be calculated correctly by the software.

MANUFACTURER: C. R. Bard, Inc., Urological Division, Covington, GA, by letter on August 29, 2002. Firm initiated recall is complete.

PRODUCT: Bardex(r) Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device. The catheter is an open whistle tip with two eyes on the same side. It is made of red latex for added catheter stiffness and radiopacity, with a Lubricath hydrophilic coating. This product has 3 lumens; a lumen for drainage, a lumen for inflation of the bladder balloon, and a lumen for inflation of the prostatic balloon. Catalog Number 6016L22. Recall # Z-1144-03.

REASON: On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports.

MANUFACTURER: Zeus Scientific, Inc., Branchburg, NJ, by letter on June 22, 2001. Firm initiated recall is complete.

PRODUCT: Anti-Cardiolipin IgA ELISA test kit. Product is manufactured for Sigma Diagnostics, Inc., Saint Louis, MO. Recall # Z-1147-03.

REASON: Bacterial contamination of the high positive control.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA., by telephone between June 18, 2003 and July 3, 2003. Firm initiated recall is ongoing.

PRODUCT: Access Immunoassay System Technical Update 03.1, Part number 387851. Recall # Z-1148-03.

REASON: Defective software media distributed with upgrade software may cause installation failure and systems lock.

MANUFACTURER: ABX Diagnostics, Inc., Irvine, CA, by letter on June 5, 2003. Firm initiated recall is ongoing.

PRODUCT: ABX Diagnostices Pentra 60C+ Hematology Analyzer. Recall # Z-1149-03.

REASON: Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 27, 2003:

CLASS II

MANUFACTURER: Encore Medical, LP, Austin, TX, by telephone on April 23, 2003. Firm initiated recall is complete.

PRODUCT: Foundation Knee System, non-porous Femur Size 8, Right. Recall # Z-1069-03.

REASON: Product container was labeled incorrectly indicating left femur instead of right.

MANUFACTURER: Boston Scientific Scimed, Maple Grove, MN, by letter dated July 1, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm / 1.5 cm /90 cm (balloon width/balloon length/catheter length), Reference Catalog Number 37915-4015. Recall # Z-1096-03;
b) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 37915-4020. Recall # Z-1097-03;
c) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-4515. Recall # Z-1098-03;
d) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-5020. Recall # Z-1099-03;
e) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-6015. Recall # Z-1100-03; f) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-6520. Recall # Z-1101-03;
g) Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-7015. Recall # Z-1102-03;
h) Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-7020. Recall # Z-1103-03;
i) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916- 4015. Recall # Z-1104-03;
j) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4020. Recall # Z-1105-03;
k) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5
mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-4515. Recall # Z-1106-03;
l) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-4515. Recall # Z-1107-03;
m) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-5015. Recall # Z-1108-03;
n) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.5 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-5520. Recall # Z-1109-03;
o) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-6015. Recall # Z-1110-03;
p) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-6515. Recall # Z-1111-03;
q) Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-7020. Recall # Z-1112-03;
r) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/150 cm, Reference Catalog Number 38950-5020. Recall # Z-1113-03;
s) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/150 cm, Reference Catalog Number 38950-6020. Recall # Z-1114-03;
t) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0mm/1.5 cm/90 cm, Reference Catalog Number 38990- 4015, Product Number H7493791540150. Recall # Z-1115-03;
u) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-4020. Recall # Z-1116-03;
v) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/1.5 cm/90 cm, Reference Catalog Number 38990-5015. Recall # Z-1117-03;
w) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-5020. Recall # Z-1118-03;
x) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-6020. Recall # Z-1119-03;
y) Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-7020. Recall # Z-1120-03.

REASON: Some of the product pouches have holes in the seals.

MANUFACTURER: Valleylab, Inc., Boulder, CO, by letter on July 16, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Radionics Disposable Grounding Plate. Recall # Z-1121-03;

b) Radionics Cool-tip RF Electrode Kit, containing DGP-HP single-use grounding pads. Recall # Z-1122-03.

REASON: Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.

MANUFACTURER: Boston Scientific Scimed, Maple Grove, MN, by letter dated July 16, 2003. FDA initiated recall is ongoing.

PRODUCT: Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235. Recall # Z-1123-03.

REASON: There is an increased potential for broken struts of the stents.

MANUFACTURER: Intralase Corp., Irvine, CA, by letters on July 15, 2003. Firm initiated recall is ongoing.

PRODUCT: Intralase FS Laser System. Laser Keratome. Recall # Z-1124-03.

REASON: Gantry moves toward patient when 'Home' button is used after procedure

MANUFACTURER: Meridian Bioscience, Inc., Cincinnati, OH, by telephone and fax on June 18, 2003. Firm initiated recall is ongoing.

PRODUCT: Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G. Recall # Z-1127-03.

REASON: The low Positive Standard kit component is losing potency that may result in false positive test results.

MANUFACTURER: Philips Medical Systems, Bothell, WA, by letter dated February 13, 2002. Firm initiated recall is ongoing.

PRODUCT: Easy Web. Recall # Z-1128-03.

REASON: Potential for incorrect body part information.

MANUFACTURER: Abbott Laboratories, Inc, Irving, CA, by Technical Service Bulletin on December 10, 2001. Firm initiated recall is complete.

PRODUCT: Architect Processing Module, List number 8C89-01. Recall # Z-1133-03.

REASON: Under specific conditions, the system can allow an incorrect sample ID to be assigned to another sample in a different carrier.

MANUFACTURER: Molnlycke Health Care, Inc., Newton, PA, by letters dated July 9, 2003. Firm initiated recall is ongoing.

PRODUCT: Barrier Hip Sheet with Side Pockets. Recall # Z-1137-03.

REASON: Pouch may tear which could result in contamination of sterile field.

CLASS III

MANUFACTURER: Diametrics Medical, Inc. Roseville, MN, by telephone on July 14, 2003. Firm initiated recall is ongoing.

PRODUCT: IRMA SL Blood Analysis System CC pH, pCO2, p)O2, Hct, Na, K, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box. Recall # Z-1072-03.

REASON: An incorrect lot designation, when entered into the blood analysis device, causes the device to give an error message and not operate.

MANUFACTURER: Hardy Media, Inc. Dba Hardy Diag., Santa Maria, CA, by telephone on June 25, 2003, and by letter. Firm initiated recall is ongoing.

PRODUCT: Blood Agar Plates, 5%. Recall # Z-1076-03.

REASON: Customers complained of bacterial contamination.

MANUFACTURER: Beckman Coulter, Inc. Brea, CA, by letter on June 19, 2003. Firm initiated recall is ongoing.

PRODUCT: Synchron LX Systems Primary Tube Sample Template (a piece of "labeling" for use with the Synchron LX 20 and LX 20 Pro systems), Part Number: 967178. Recall # Z-1077-03.

REASON: Dead volume on sight gauge for the Synchron LX 20 Pro Systems not stated, which may result in instrument error.

MANUFACTURER: Fresenius Hemocare, Inc., Redmond, WA, by letter dated July 10, 2003. Firm initiated recall is ongoing.

PRODUCT: Prosorba Protein A Immunoadsorption Column. Recall # Z-1086-03.

REASON: No package insert.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letters dated February 28, 2003, March 01, 2003, and April 14, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) MR Systems. Recall # Z-1087-03;
b) Leonardo Workstations with software version 2022A/B, 2003A. Recall # Z-1088-03;
c) Leonardo Workstations with software versions prior to 2022A. Recall # Z-1089-03.

REASON: Software problem. This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.

MANUFACTURER: Coopervision, Inc., Scottsville, NY, by telephone on July 22, 2003. FDA initiated recall is complete.

PRODUCT: Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Recall # Z-1091-03.

REASON: Mislabeled with incorrect sphere power.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on June 23, 2003. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory System versions 5.3 up to 5.3.2 with Lab Access Results Workstation. Recall # Z-1093-03.

REASON: Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatment.

MANUFACTURER: Olympus America, Inc., Melville, NY, by letters, dated March 5, 2003. Firm initiated recall is ongoing.

PRODUCT: Olympus Image Manager Software. Recall # Z-1126-03.

REASON: Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.

MANUFACTURER: Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letters dated July 21, 2003. Firm initiated recall is ongoing

PRODUCT: Imx Rubella IgM Reagent Kit, 100 tests. Recall # Z-1129-03.

REASON: The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.

MANUFACTURER: Abbott Park Laboratories, Abbott Park, IL, by letter dated May 30, 2003, and June 4, 2003. Firm initiated recall is ongoing

PRODUCT:
a) Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L-0.7,M - 1.2 and H - 3.0. Recall # Z-1130-03;
b) Imx Free T4 Reagent Kit, list 2222-20, 100 test kit. Recall # Z-1131-03;
c) Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0. Recall # Z-1132-03.

REASON: The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 20, 2003:

CLASS II

MANUFACTURER: Deltec, Inc, St. Paul, MN, by letter on July 8, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Ventra Percutaneous Intravenous Catheter Repair Kit for Luer Connector Segments and Single-Lumen Catheters, Reorder Number 21-0105. Recall # Z-1066-03;
b) Ventra Percutaneous Intravenous Catheter Repair Kit for 9 French Dual-Lumen External Catheter Segment, Reorder Number 21-0106. Recall # Z-1067-03;
c) Ventra Percutaneous Intravenous Catheter Repair Kit for 11 French Triple-Lumen External Catheter Segment, Reorder Number 21-0107. Recall # Z-1068-03.

REASON: Silicone adhesive in kits used to repair damaged catheters does not set (cure) properly and remains in a tacky state.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letters on or about April 28, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Cyto-Stat/Coulter Clone B6-RD, Part number 6604426. Recall # Z-1070-03;
b) Coulter Clone B6-FITC Reagent. Recall # Z-1071-03.

REASON: Diminished expression on B-Cell populations when drawn in EDTA tubes, which may lead to inaccurate interpretation of phenotype results.

MANUFACTURER: Rx Textiles, Inc., Monroe, NC, by email on June 11, 2003, and by letter on June 18, 2003. Firm initiated recall is ongoing.

PRODUCT: PHS, Tubular Stockinette Cotton, 6'x 48', 8'x 72', 4'x 60' and 4'x 48' Double Ply, 6'x 72', 4'x 48' and 6'x 48' Single Ply and 4' x 4 YDS, 6' x 4 YDS and 3'x 4YDS, 1/pk 25 pk/cs. Recall # Z-1074-03.

REASON: Product may not be sterile.

MANUFACTURER: Guidant Corporation ACS, Temecula, CA, by letter on 07/15/2003. Firm initiated recall is ongoing.

PRODUCT: Guidant Multi-Link Zeta Coronary Stent System. Recall # Z-1075-03.

REASON: Potential loss of package sterility.

MANUFACTURER: Alcon Laboratories, Inc., Orlando, FL, by letters on July 21, 2003. Firm initiated recall is ongoing.

PRODUCT: "Alcon Ladarwave Custom Cornea Wavefront System" Aberrometer software Version 7.91. Recall # Z-1078-03.

REASON: Software error could, under specific circumstances, allow the patient's centration images and data to be stored incorrectly.

MANUFACTURER: Ballard Medical Products, Draper, UT, by letter on June 13, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Kimberly-Clark/Ballard TRACH-CARE*MAC (Multi Access Catheter) for Neonates. Recall # Z-1079-03;
b) Kimberly-Clark / Ballard TRACH-CARE*MAC (Multi Access Catheter) for Neonates. Recall # Z-1080-03;
c) Kimberly-Clark / Ballard TRACH-CARE*MAC (Multi Access Catheter) for Neonates. Recall # Z-1081-03;
a) Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. Recall # Z-1082-03;
b) Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. Recall # Z-1083-03;
c) Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. For international distribution only. Recall # Z-1084-03;
d) Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. For distribution to Germany only. Recall # Z-1085-03.

REASON: Incorrect plug was included in the multi access catheter pkg. When inserted in the "Y" it may disengage, allowing a leak of ventilator gases.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on June 16, 2003. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory System. Recall # Z-1090-03.

REASON: Software anomaly allows patient reports to contain incomplete data used for Anatomic Pathology Module.

MANUFACTURER: Misys Healthcare System, Tucson, AZ, by fax on July 2, 2003. Firm initiated recall is complete.

PRODUCT: Misys Laboratory System. Recall # Z-1092-03.

REASON: Patient files become mixed up due to a software defect.

MANUFACTURER: Zeus Scientific, Inc., Raritan, NJ. Firm initiated recall is ongoing. Recalling Firm: Zeus Scientific, Inc., Branchburn, NJ, by letter on June 12, 2003.

PRODUCT: Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic. Recall # Z-1095-03.

REASON: The Calibrator included within the kit may be losing reactivity.

CLASS III

MANUFACTURER: Zeus Scientific, Inc., Branchburg, NJ, by letters on February 24, 2000. Firm initiated recall is complete.

PRODUCT: Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabosorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. Recall # Z-1065-03.

REASON: The high positive control/low positive standard ratio recovering too low.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 6, 2003:

CLASS II

MANUFACTURER:Stryker Instruments, Instruments Div., Kalamazoo, MI, by letters dated June 12, 2003. Firm initiated recall is ongoing.

PRODUCT:Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000. Recall # Z-0921-03.

REASON:Non-sterilized product sold as sterile.

MANUFACTURER:Cardinal Health, McGaw Park, IL, by letter dated June 27, 2003. Firm initiated recall is ongoing.

PRODUCT:Custom Sterile Surgical Procedure Packs. The product packaging consists of a vented polybag with a label insert inside the polybag.

a) Sterile Minor Extremity Pack, Catalog SOP11MEMMD, order 101449. Recall # Z-1020-03;
b) Sterile Major Abdominal Pack, Catalog SBA21MAHVJ, order 101491. Recall # Z-1021-03;
c) Sterile General Local Tray, Catalog SBA11GLMMD, order 101466. Recall # Z-1022-03;
d) Sterile Laparotomy Pack, Catalog SBA61MJSFH, order 101438. Recall # Z-1023-03;
e) Sterile General Surgery Pack, Catalog SBA35GSMOG, order 101467. Recall # Z-1024-03.

REASON: The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.

MANUFACTURER:Quest Medical, Inc., Allen, TX, by letters via fax on May 23, 2003, May 28, 2003, and May 29, 2003. Firm initiated recall is ongoing.

PRODUCT:Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes. Recall # Z-1037-03.

a) Catalog Number: 5001102;
b) Catalog Number: 5001104;
Lots manufactured but not distributed:
c) Catalog Number: 6001101; d) Catalog Number: 7001102.

REASON: Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open-heart surgery.

MANUFACTURER: Cryolife, Inc. Kennesaw, GA, by letter on July 10, 2003. Firm initiated recall is ongoing.

PRODUCT:CryoValve, Synegraft Pulmonary Valve & Conduit.

Recall # Z-1038-03.

REASON: Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms was distributed.

MANUFACTURER:Depuy Orthopaedics, Inc. Warsaw, IN, by Urgent Recall Notice on June 27, 2003. Firm initiated recall is ongoing.

PRODUCT:a) ProVision Hytrel Elastomer Hood, product 5431-05-000.
Recall # Z-1040-03;
b) ProVision Hytrel Universal Hood/Gown, product 5431-31-000. Recall # Z-1041-03;
c) ProVision Barrier Universal Hood/Gown, product 5431-33-000. Recall # Z-1042-03;
d) ProVision Disposable Hood, product 5431-50-000.
Recall # Z-1043-03;

REASON: Lack of assurance of sterility, due to the possibility of an incomplete package seal.

MANUFACTURER:Roche Diagnostics, Corp., Indianapolis, IN, by letter dated June 26, 2003. Firm initiated recall is ongoing.

PRODUCT:MagNA Pure LC Instrument, Catalog number 2236931. Recall # Z-1044-03.

REASON: A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols.

MANUFACTURER:Henry Schein, Inc., Melville, NY, by telephone on June 27, 2003, and by letters on June 27, 2003 and July 10, 2003. FDA initiated recall is ongoing.

PRODUCT:
a) Positive Touch (TM) TEXTURED POWDER-FREE LATEX EXAM GLOVES, Large. Reorder No. 8843. Single Use Only. Qty. 100 Per Box (50 pairs), 1000 Per Case.
Recall # Z-1045-03;
b) Positive Touch (TM) SMOOTH POWDER-FREE LATEX EXAM GLOVES, Large. Reorder No. 8878. Single Use Only. Qty. 100 Per Box (50 pairs), 1000 Per Case.
Recall # Z-1046-03.

REASON: FDA's analysis revealed defects (holes) in the latex gloves.

MANUFACTURER:Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter dated June 12, 2003. Firm initiated recall is ongoing.

PRODUCT:AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21 (French label), and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0). Recall # Z-1047-03.

REASON: AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%.

MANUFACTURER: Power Medical Interventions, New Hope, PA, by letter dated June 30, 2003. FDA initiated recall is ongoing.

PRODUCT:
a) SurgASSIST System. Circular Stapler DLU 29 mm, product code CS29. Recall # Z-1048-03;
b) SurgASSIST System. Circular Stapler DLU 33 mm, product code CS33. Recall # Z-1049-03

REASON: Latching mechanism failure.

MANUFACTURER:Encision, Inc., Boulder, CO, by visits beginning June 23, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Active Electrode Monitoring System. EM2 NC AEM Monitor (NON-COM). Catalog Number EM2 NC. Recall # Z-1050-03;
b) Active Electrode Monitoring System. EM2+A NC AEM Monitor (NON-COM). Catalog Number EM2+A NC.  Recall # Z-1051-03.

REASON: Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.

MANUFACTURER:LMA North America Inc., San Diego, CA, by letters on June 18, 2003. Firm initiated recall is ongoing.

PRODUCT:LMA-Unique Laryngeal Mask Airway Size 4, Catalog No. 12140, and Catalog No. 12150. Recall # Z-1053-03.

REASON: Sterility cannot be assured.

MANUFACTURER:Medex, Inc., Duluth, GA, by letter dated June, 2003. Firm initiated recall is ongoing.

PRODUCT:Medex 2000 Series Syringe Infusion Pumps.

The 2001 series is a general use pump, 2001E is for German use, 2001G is for use in the UK, 2001T is for use in Taiwan, 2010iK is for use in Korea, (the pumps with different languages have different syringes than those used in the U.S.), 001H has a different power cord connector, "VX" in the suffix means it is an evaluation pump, "NFHU" is not for human use; used in test labs for testing purposes, 2010 has an anesthesia mode built into the software, "ZE" are returned because of outdated software. They are refurbished or up graded and re-distributed, 2010i has an anesthesia mode and library mode for programming. Recall # Z-1060-03.

REASON: Inadequate warning label as pertains to use of the pump in conjunction with Extracorporeal Membrane Oxygenation (ECMO) procedures.

MANUFACTURER:Boston Scientific Corporation, Natick, MA, by letter on July 3, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250. Recall # Z-1061-03;
b) ASAP Channel Cut Biopsy System, 15 gauge Reference Number: 1390. Recall # Z-1062-03;
c) ASAP Channel Cut Biopsy System, 18 gauge Reference Number: 1394. Recall # Z-1063-03.

REASON: Sterility of the device may be compromised due to a lack of package integrity.

MANUFACTURER:Ohmedia Medical, A division of Datex-Ohmeda, Inc., Laurel, MD, by e-mail and telephone on June 13, 2003. Firm initiated recall is complete.

PRODUCT:
a) Servo Controlled Oxygen System for Ohmeda's Medical Giraffe OmniBed; b) Ohmeda's Medical Girraffe Incubators. Recall # Z-1064-03.

REASON: Medical device malfunction affecting instrument's calibration and alarm systems.

CLASS III

MANUFACTURER:Portex, Inc., Keene, NH, by telephone on June 18th and 19th, 2003. Firm initiated recall is ongoing.

PRODUCT:Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D.9.0mm Catalog Number: 593090. Recall # Z-1039-03.

REASON: Mislabeled: Tracheostomy tube was not fenestrated as specified on the label.

MANUFACTURER:Cook, Inc., Bloomington, IN, by letter dated July 1, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Cook Polyvinyl Alcohol Foam (PVA) Embolization particles, particle size 47-90 microns, 1 cc; order number PVA-50. Recall # Z-1054-03;
b) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 90-180 microns, 1 cc; order number PVA-100. Recall # Z-1055-03;
c) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 180-300 microns, 1 cc; order number PVA-200. Recall # Z-1056-03;
d) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 300-500 microns, 1 cc; order number PVA-300. Recall # Z-1057-03;
e) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 500-710 microns, 1 cc; order number PVA-500. Recall # Z-1058-03;
f) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 710-1000 microns, 1 cc; order number PVA-700. Recall # Z-1059-03.

REASON: Vial contains less product than is declared on the label.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 30, 2003:

CLASS II

MANUFACTURER: Portex Ltd., Hythe, Kent, GB, by telephone on May 16, 2003, and by letter on May 17, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Portex Uncuffed Nasal Tracheal Tubes, Ivory 5mm x 25cm Reference Number: 100/105/050. Recall # Z-0991-03; b) Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3mm x 17cm Reference Number: 100/111/030. Recall # Z-0992-03; c) Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3.5mm x 19cm Reference Number: 100/111/035. Recall # Z-0993-03; d) Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 8mm x 33cm Reference Number: 100/111/080. Recall # Z-0994-03; e) Portex Uncuffed Oral Tracheal Tubes, Siliconised 6mm x 19cm Reference Number: 100/126/060. Recall # Z-0995-03; f) Portex Uncuffed Oral/Nasal Tracheal Tube, Murphy Eye Clear 3.5mm x 19cm Reference Number: 100/127/035. Recall # Z-0996-03; g) Portex Uncuffed Oral/Nasal Tracheal Tubes, Murphy Eye Siliconised 5mm x 25cm Reference Number: 100/141/050. Recall # Z-0997-03; h) Portex Tracheal Tube Profile Soft-Seal Cuff, Ivory Nasal 5mm x 25cm Reference Number: 100/179/050.Recall # Z-0998-03; i) Portex Profile Soft-Seal Cuff Oral/Nasal Tracheal Tube, Clear Murphy Eye 8 mm x 33cm Reference Number: 100/199/080. Recall # Z-0999-03.

REASON: Tracheal tubes may be non-sterile.

MANUFACTURER: Zoll Medical Corporation, Burlington, MA, by letter on June 25, 2003 and June 26, 2003. Firm initiated recall is ongoing.

PRODUCT: Zoll M Series External Defibrillator. Recall # Z-1000-03.

REASON: Defibrillator may fail to charge or hold its charge above energies of 75 joules.

MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, by letter dated May 27, 2003. Firm initiated recall is ongoing.

PRODUCT: MagNA Pure LC Instrument; Catalog number 2236931. Recall # Z-1001-03.

REASON: Potential for false negative patient results with software version 3.0.

MANUFACTURER: Coapt Systems, Inc., Palo Alto, CA., by letters on May 19, 2003. Firm initiated recall is ongoing.

PRODUCT: Drill bits used in ENDOTINE Forehead( 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303. Recall # Z-1002-03.

REASON: During use, the device has a potential for unacceptable deep hole in the cranium, which can cause patient injury.

MANUFACTURER: EBI, L.P., Parsippany, NJ, by letter dated June 17, 2003. Firm initiated recall is ongoing.

PRODUCT: EDI VueCath Endoscopic Spinal System. Catalog Number: S002. Recall # Z-1006-03.

REASON: Non sterile device is labeled sterile.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on June 10, 2003, and on June 13, 2003. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory System. Recall # Z-1007-03.

REASON: Software anomally. Results with a global flag failure that auto file without review can cause abnormal results being communicated without associated abnormal designations.

MANUFACTURER: Sanarus Medical, Inc., Pleasanton, CA, by letter on June 16, 2003. Firm initiated recall is ongoing.

PRODUCT: Sanarus Visica( Treatment System (disposable), Model/ Product Code: VP-0500 (single). Recall # Z-1008-03.

REASON: Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.

MANUFACTURER: Guidant Corp-Cpi Division, St Paul, MN, by letter, dated June 23, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Pulsar Max II Multiprogrammable Pacemaker, Model 1180. Recall # Z-1009-03; b) Pulsar Max II Multiprogrammable Pacemaker, Model 1181. Recall # Z-1010-03; c) Discovery II Multiprogrammable Pacemaker, Model 0481. Recall # Z-1011-03; d) Discovery II Multiprogrammable Pacemaker, Model 0981. Recall # Z-1012-03; e) Discovery II Multiprogrammable Pacemaker, Model 1184. Recall # Z-1013-03; f) Discovery II Multiprogrammable Pacemaker, Model 1283. Recall # Z-1014-03; g) Discovery II Multiprogrammable Pacemaker, Model 1284. Recall # Z-1015-03; h) Discovery II Multiprogrammable Pacemaker, Model 1286. Recall # Z-1016-03; i) Discovery II Multiprogrammable Pacemaker, Model 1280. Recall # Z-1017-03;

REASON: Some of the pacemakers may fail to pace due to an inadequately soldered electrical connection at an integrated circuit.

MANUFACTURER: Medisav Services, Inc., Ontario L3S 1Y7, Canada. FDA initiated recall is ongoing

PRODUCT: MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesive for soft tissue approximation; 0.22 cc plastic squeeze tubes packaged in a Tyvek/PPE pouch with paper label, 10 units per case. Recall # Z-1018-03.

REASON: The liquid tissue adhesive was marketed with FDA pre-market clearance.

MANUFACTURER: Vail Products, Inc., Toledo, OH, by letter in April 2003, and by telephone, fax, and letter on June 30, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Vail Enclosed Bed System, model 1000. Recall # Z-1025-03; b) Vail Enclosed Bed System, model 2000. Recall # Z-1026-03.

REASON: Patients may become entrapped between the bottom side rail and mattress.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letters dated June 20, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Hill-Rom Newborn bassinet, model P247. Recall # Z-1027-03; b) Hill-Rom Newborn bassinet, model P248. Recall # Z-1028-03.

REASON: The caster/wheel may come off of the bassinet, causing the bassinet to tip.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated February 28, 2002. Firm initiated recall is ongoing

PRODUCT: Magic View 1000U, version VE40A. Digital Image Communication System. Recall # Z-1029-03.

REASON: Software issue. New examinations may not be saved properly and the examination may be lost.

MANUFACTURER: Boston Scientific Corporation, Natick, MA, by sales representatives' visit beginning on June 23, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Fibered Platinum Coil, 0.035 Type, 4 mm x 30 mm. Catalog no. 372403. Recall # Z-1033-03; b) Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm. Catalog no. 372906. Recall # Z-1034-03.

REASON: Product's Outer box label may not match pouch label: a 4 mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa.

MANUFACTURER: Arrow International, Inc., Reading, PA, by letters dated July 9, 2003. Firm initiated recall is ongoing.

PRODUCT: 9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath. Catalog numbers AK-07903-AG, SI-07903-AG, JM-07903-AG, and CI-07903-AG. Recall # Z-1035-03.

REASON: Separation of sheath.

MANUFACTURER: Allergan Medical Optics Inc., Santa Ana, CA, by letters on July 2, 3, and 8, 2003. Firm initiated recall is ongoing.

PRODUCT: AMO PhacoFlex II Model SI40NB, Intraocular Lenses. Recall # Z-1036-03.

REASON: Post operative complaints of cloudiness in the intraocular lenses.

CLASS III

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by a reagent bulletin dated September 30, 2002. Firm initiated recall is complete.

PRODUCT: Roche/Hitachi Tina-quant RF II; catalog # 3004902. Recall # Z-1030-03.

REASON: Test results may exhibit a positive bias when plasma samples are used for the assay.

MANUFACTURER: Zeus Scientific Inc., Branchburg, NJ, by DHL on November 9, 2001. Firm initiated recall is complete.

PRODUCT: Rheumatoid Factor ELISA Test Kit. Labeled under the following names: a) Sigma Diagnostics, Inc, Saint Louis, MO. Product Number 507-B; b) Zeus Scientific, Inc., Branchburg, NJ. Product Number 2Z921M. Recall # Z-1031-03. REASON: Calibrator C not meeting its optical density specification.

MANUFACTURER: Siemens Medical Solutions USA, Inc., by letter on October 30, 2002. Firm initiated recall is complete.

PRODUCT: Cathcor/LX/Desktop, System, X-Ray, Angiographic. Recall # Z-1032-03.

REASON: Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 23, 2003:

CLASS II

MANUFACTURER: Abbott Laboratories HPD/ADD, Abbott Park, IL, by letters dated June 9, 2003, June 13, 2003, and July 7, 2003. Firm initiated recall is ongoing.

PRODUCT: A) Vented and Non-Vented Burette I.V. Gravity Feed Administration Sets; sterile, Rx, single use devices; 15 different sets listed. Recall # Z-0955-03; several different sizes under this recall B) I.V. Extension Sets; sterile, Rx, single use devices; 22 different sets listed in the code information section below. Recall # Z-0956-03; Please Note: items p, q & r (list 191700204, 191700404 and 191700415) were packaged in kits with Sporanox Injection distributed by Ortho Biotech Products, Raritan, NJ. C) Primary I.V. Gravity Administration Sets; sterile, Rx, L 60064 USA; 95 different sets listed, several different sizes. Recall # Z-0957-03; D) I.V. Pump Sets with Cassettes for use with Abbott Plum Series and Lifecare Infusion Pumps; sterile, Rx, single use devices; 86 different sets listed. Recall # Z-0958-03; a) LifeShield Latex-Free Primary I.V. Pump Set with E) Secondary I.V. Gravity Feed Sets; sterile, Rx, single use devices; 15 different sets listed. Recall # Z-0959-03; several sizes involved

REASON: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

MANUFACTURER: Cobe Cardiovascular, Inc, Arvada, CO, by telephone and letter on May 9, 2003. Firm initiated recall is complete.

PRODUCT: Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt. Catalog # 027819201. Recall # Z-0960-03.

REASON: Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.

MANUFACTURER: MedAmicus, Inc., Plymouth, MN, by letters dated June 6, 2003 or June 20, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Medamicus FlowGuard 16FR Valved Peelable Introducer Kit, Catalog Number 10532-011. Recall # Z-0962-03; b) Medamicus FlowGuard 15FR Valved Peelable Introducer Kit, Catalog Number 10532-010. Recall # Z-0963-03; c) Angio Dynamics 14F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507601. Recall # Z-0964-03; d) Angio Dynamics 15F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507602. Recall # Z-0965-03; e) Angio Dynamics 16F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507603. Recall # Z-0966-03; f) Medamicus FlowGuard 16FR Valved Peelable Introducer Kit, Catalog Number 10684-003. Recall # Z-0967-03 g) Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011. Recall # Z-0968-03.

REASON: Stability testing, after accelerated aging of the device, shows that the handle of device does not meet strength specifications

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by Recall Notice on March 19, 2003. Firm initiated recall is complete.

PRODUCT: Misys Laboratory System. Recall # Z-0972-03.

REASON: Abnormal results are flagged as normal.

MANUFACTURER: PerkinElmer Life Sciences, Inc., Norton, OH, by telephone on May 16, 2002. Firm initiated recall is complete.

PRODUCT: Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit. Catalog # FR-8050. Recall # Z-0973-03.

REASON: The CSF Gels were manufactured incorrectly resulting in irregular wavy bands.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax dated June 2, 2003. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory System using Microbiology versions 5.2 (build 4 and higher), 5.23 and 5.3. Recall # Z-0974-03.

REASON: Susceptibility comments are ommited from Microbiology cumulative reports.

MANUFACTURER: Siemans Medical Solutions USA, Inc., Plymouth Meeting, PA, by letter dated April, 2003. Firm initiated recall is ongoing.

PRODUCT: Acuson Cypress Echocardiography System, Imaging System. Catalog # 8264604. Recall # Z-0975-03.

REASON: Software problem - loss of data.

MANUFACTURER: Siemens Medical Solutions, USA, Inc., Malvern, PA, by letter in May 2003. Firm initiated recall is ongoing.

PRODUCT: Axiom Sensis. Programmable Diagnostic Computer. Recall # Z-0979-03.

REASON: Software problem - erroneous results or system crashes.

MANUFACTURER: Deltec, Inc., St. Paul, MN, by letter on June 23, 2003. Firm initiated recall is ongoing.

PRODUCT: Deltec CASS-Prizm PCS II Ambulatory Infusion Pump with Revision E Software. Recall # Z-0980-03.

REASON: Pump keyboard entries by the patient can result in the patient having unintended access to programming screens and result in improper drug dosage.

MANUFACTURER: A. R. C. Laser Corp., Salt Lake City, UT, by telephone on June 6, 2003, and by fax and letter on June 10, 2003. Firm initiated recall is ongoing.

PRODUCT: A.R.C. Laser Photolysis Probes/Handpieces. Catalog Number LY11002. Recall # Z-0981-03.

REASON: Product may not have been properly sterilized.

MANUFACTURER: Numed Inc., Hopkinton, NY, by letters dated June 26, 2003. FDA initiated recall is ongoing.

PRODUCT: CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in laser welded rows with a "zig" pattern. The number of zigs can be varied and will impact the strength of the stent as well as the eventual diameter and percent stent shortening. CP stents are sold either sterile or non-sterile, and sold in different lengths. Recall # Z-0983-03.

REASON: Lacks a 510k clearance for marketing.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letters dated April 19, 2003. Firm initiated recall is ongoing.

PRODUCT: Axiom Aristos X-Ray System. Recall # Z-0984-03.

REASON: Software malfunction. May indicate that the image is flipped when it is not.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letters dated April 15, and April 23, 2003. Firm initiated recall is ongoing.

PRODUCT: 3D Ceiling Suspension. Recall # Z-0987-03.

REASON: The back up safety catch may not function properly.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letters on May 5, 2003. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft Aortic Valve and Conduit. Recall # Z-0988-03.

REASON: Donor of distributed allograft was diagnosed with dilated/ischemic cardiomyopathy..

MANUFACTURER: Hill-Rom Manufacturing, Inc., Charleston, SC, by letter on May 5, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Clinitron CII Air Fluidized Therapy unit. Recall # Z-0989-03; b) Clinitron Up-Lift Air Fluidized Therapy unit. Recall # Z-0990-03.

REASON: Malfunction of side-rail latching pin coupled with inadequate directions for use.

MANUFACTURER: Nipro Corp, Miami, FL, by letter on November 8, 2002. Firm initiated recall is ongoing.

PRODUCT: Nipro SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula Set and EXEL Secure Touch Safety AV Fistula Needle Set. Recall # Z-0408-03.

REASON: Air or fluid leakage at the hub/needle junction.

CLASS III

MANUFACTURER: Zeus Scientific, Inc., Branchburg, NJ, by letter on March 19, 2001. Firm initiated recall is complete.

PRODUCT: Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055. Recall # Z-0961-03.

REASON: Mix-up between low positive and negative controls.

MANUFACTURER: PerkinElmer Life Sciences, Inc., Norton, OH, by telephone and facsimile on May 30, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Neonatal Total Galactose Test Kit, Item #NG-1000, Filter #903, contents for 960 assays. Recall # Z-0969-03; b) Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays. Recall # Z-0970-03; c) Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays. Recall # Z-0971-03.

REASON: The device is not stable throughout its labeled expiration date.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter in November, 2002. Firm initiated recall is complete.

PRODUCT: Magnetom Symphony/Sonata, OR Table. Recall # Z-0976-03.

REASON: OR Table stops during the transfer of the table to the MR system and will not move.

MANUFACTURER: Coopervision, Inc., Scottsville, NY, by letters dated June 24, 2003. Firm initiated recall is ongoing.

PRODUCT: Soft Contact Lenses (toric) packaged under the following labels: CV/ENCORE toric (methafilcon A) and ONEVUE 55 toric (methafilcon A) flexible wear. Recall # Z-0978-03.

REASON: The actual sphere power of the lens is lower than the labeled value.

MANUFACTURER: Ventlab Corporation, Mocksville, NC, by fax on March 15, 2003. Firm initiated recall is ongoing.

PRODUCT: V*CARE, Infant Resuscitator, with 40 cm H_O Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background, which included Direction for Use statement #5. To remove vomitus: Disconnect resuscitator from patient. Tap the patient valve several times while squeezing the bag body. Retest the resuscitator for proper functioning. Recall # Z-0982-03.

REASON: Printed bag with instructions to verify the pressure with a "certified manometer" was omitted in some of the product.

MANUFACTURER: Ethicon Endo-Surgery, Cincinnati, OH, by letter on May 21, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm. Recall # Z-0985-03. b) Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TLC10, staple size: 3 mm x 3.85 mm. Recall # Z-0986-03.

REASON: The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.

MANUFACTURER: Life-Tech International, Inc, Stafford, TX, by letter on May 9, 2001. Firm initiated recall is complete.

PRODUCT: ProLong Continuous Nerve Block Set. Recall # Z-1003-03.

REASON: Catheter does not fit through the needle resulting in delay of medical procedure.

MANUFACTURER: Mitek Worldwide, Norwood, MA, by letter on June 16, 2003

PRODUCT: a) Mitek Products. Profile 7 x 25 mm Cannulated Interference Screw Round Head Catalog Number: 230325. Recall # Z-1004-03; b) Profile 8 x 20 mm Cannulated Interference Screw Round Head Catalog Number: 230420. Recall # Z-1005-03.

REASON: Mislabeled - Incorrect Screw Size. The unit labeled 7x25 mm screw may be a 8x20 mm; and the unit labeled 8x20 mm may be a 7x25 mm.

MANUFACTURER: Boston Scientific Corporation, Natick, MA, by letter on June 26, 2003. Firm initiated recall is ongoing.

PRODUCT: Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number 6557. Recall # Z-1019-

REASON: Mislabeled; Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 16, 2003:

CLASS II

MANUFACTURER: Getinge/Castle, Inc., Rochester, NY, by letter dated March 25, 2003. Firm initiated recall is ongoing.

PRODUCT: Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden. Recall # Z-0908-03.

REASON: Hot water may splash from the washer chamber creating a burn hazard.

MANUFACTURER: Draeger Medical, Inc., Telford, PA, by letters dated May 7, 2003. Firm initiated recall is ongoing.

PRODUCT: Evita 4 Continuous Ventilator. Catalog numbers 4116640 and 8412980. Recall # Z-0954-03.

REASON: Software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 9, 2003:

CLASS I

MANUFACTURER: Respironics California, Inc., Carlsbad, CA, by Field Communication 2001-25 dated June 8, 2001. Firm initiated recall is complete.

PRODUCT: ESPRIT Ventilator, Model V1000. Recall # Z-0951-03.

REASON: Material hardness on original design check valve may cause premature failure.

CLASS II

MANUFACTURER: The OR Group, Inc., Acton, MA, by letter on June 6, 2003. Firm initiated recall is ongoing.

PRODUCT: Allen Medical Systems PAL Pro Stirrups. Catalog Number A-10051-A1. Recall # Z-0953-03.

REASON: Foot Stirrups may detach from mount when user is locking system.

MANUFACTURER: Abbott Laboratories HPD/ADD, Abbott Park, IL, by letters dated June 9, 2003, and June 13, 2003. Firm initiated recall is ongoing.

PRODUCT:
A) Vented and Non-Vented Burette I.V. Gravity Feed Administration Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL. Recall # Z-0955-03;

B) I.V. Extension Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL. Please Note: items p, q & r (list 191700204, 191700404 and 191700415) were packaged in kits with Sporanox Injection distributed by Ortho Biotech Products, Raritan, NJ. Recall # Z-0956-03;

C) Primary I.V. Gravity Administration Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL. Please note, item k, list 018810458, lot 910824W, was also case packed with Liposyn II 20%, list 09793-04-03, lot 94533DF and list 09792-04-02, lot 92522DF, distributed by Abbott Laboratories, North Chicago, IL. Recall # Z-0957-03;

D) I.V. Pump Sets with Cassettes for use with Abbott Plum Series and Lifecare Infusion Pumps; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL. Recall # Z-0958-03;

E) Secondary I.V. Gravity Feed Sets; sterile, Rx, single use devices. Recall # Z-0959-03.

REASON: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

CLASS III

MANUFACTURER: Standard Imaging, Inc., Middleton, WI, by telephone, and letter dated May 28, 2003. Firm initiated recall is ongoing.

PRODUCT: Exradin A12 Ionization Chamber. Recall # Z-0952-03.

REASON: Ionization chambers, used for checking x-ray equipment, are experiencing some drift from the tested calibration factors.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 2, 2003:

CLASS II

MANUFACTURER: Philips Medical Systems, Bothell, WA, by letter beginning June 12, 2003. Corrections are expected to be completed by the end of October 2003. Firm initiated recall is ongoing.

PRODUCT: OmniDiagnost x-ray systems. Recall # Z-0874-03.

REASON: The units do not provide the source to image receptor distance (SID) on the beam limiting device.

MANUFACTURER: Canon USA, Inc., Irvine, CA, by letters on March 11, and March 26, 2003. Firm initiated recall is ongoing.

PRODUCT: Rational Imaging TM Software, model Ultra 10 PACS System. Recall # Z-0905-03.

REASON: Imaging archive system software mismatches images and patient names.

MANUFACTURER: Fresenius Hemocare, Inc., Redmond, WA, by telephone on January 21, and January 23, 2003, and by letter on January 21, 2003. Firm initiated recall is complete.

PRODUCT: ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR 40 Autotransfusion Reservoir. The component that is the subject of the recall is the AT1 Autotransfusion Set. Recall # Z-0906-03.

REASON: Sterility may be compromised.

MANUFACTURER: Immedica, Inc., Chatham, NJ, by letter on February 10, 2003. Firm initiated recall is ongoing

PRODUCT: TransFx Pin, External Fixation Pin. 3.0/4.0mm x 80mm, 20mm thread. Recall # Z-0907-03.

REASON: Mislabeled, wrong identification number on pin.

MANUFACTURER: Getinge/Castle, Inc., Rochester, NY, by letter dated March 25, 2003. Firm initiated recall is ongoing.

PRODUCT: Model 8666 Washer/Disinfector with holding tank heater option. Recall # Z-0908-03.

REASON: Hot water may splash from the washer chamber creating a burn hazard.

MANUFACTURER: Bayer HealthCare LLC, Diagnostics Div., Elkhart, IN., by letter on May 13, 2003, and on or about June 20, 2003. Firm initiated recall is ongoing.

PRODUCT: Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6516C, 6516F, and 6518C. (The different product codes are for the various countries where the product is distributed). Recall # Z-0911-03.

REASON: Analyzer will produce erroneous results due to missing grounding strap.

MANUFACTURER: Safco Dental Supply Co., Inc., Northbrook, IL, by letter dated May 30, 2003. Firm initiated recall is ongoing.

PRODUCT: Supergrade Earloop Masks, surgical mask; 50 masks per box. Recall # Z-0944-03.

REASON: The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on May 12, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Uroview 2000 X-ray System. Recall # Z-0945-03; b) Uroview 2500 X-ray System. Recall # Z-0946-03; c) Uroview 2600 Uroview System. Recall # Z-0947-03.

REASON: Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.

MANUFACTURER: Pioneer Surgical Technology, Marquette, MI, by letter dated May 29, 2003. Firm initiated recall is ongoing.

PRODUCT: StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer. Recall # Z-0948-03.

REASON: Label may bear an incorrect part number (2227-02-02) and size (03.8MM).

MANUFACTURER: Alphatec Mfg., Inc., Carlsbad, CA, by letter dated May 19, 2003. Firm initiated recall is ongoing.

PRODUCT: Alpha Mirage Top Tightening Spinal System 5.5 mm x 45 mm Length Bone Screws. Recall # Z-0949-03.

REASON: Laser marking is wrong on bone screws, says 40 and is 45 mm long.

CLASS III

MANUFACTURER: Disc Orthopaedic Technologies, Inc., Cranbury, NJ, by letters on October 14, and December 11, 2002. Firm initiated recall is complete.

PRODUCT: Fixion PF ("Proximal Femur") Hip Peg. Fixion PF Hip Pegs are manufactured in the following various lengths; 80mm, 81mm, 90mm, 91mm, 100mm, 101mm, 105mm, 110mm, 111mm, 120mm, and 121mm. The Fixion PF Hip Peg is intended for use in the fixation of proximal fractures in the femur. Recall # Z-0943-03.

REASON: The Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure.

MANUFACTURER: The Binding Site, Inc, San Diego, CA, by fax on March 27, 2003. Firm initiated recall is complete.

PRODUCT: Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029. Recall # Z-0950-03.

REASON: Risk of false positives.
 

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