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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