September 12, 2001 01-36RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1333-1, Red Blood Cells, Unit FG40549 REASON: Blood product, collected from a donor whose hemoglobin/hematocrit was not documented, was distributed. MANUFACTURER/RECALLING FIRM: Healthcare Provider Services Inc., dba Rhode Island Blood Center, Providence, RI RECALLED BY: The recalling firm, by telephone on January 5, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: RI QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1661-1, Red Blood Cells, Washed, Unit 9523595 REASON: Blood product, collected from a donor taking the drug Lupron, was distributed. MANUFACTURER/RECALLING FIRM: Medic Regional Blood Center, Knoxville, TN RECALLED BY: The recalling firm, by telephone on July 8, 1999, and by letter dated July 9, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1833-1, Red Blood Cells, Unit FG38350 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Healthcare Provider Services Inc., dba Rhode Island Blood Center, Providence, RI RECALLED BY: The recalling firm, by letter on March 1, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: R.I. QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1834-1, Corneas, Tissue Numbers 01-0641-OD, 01-0641-OS REASON: Corneas, from a donor who tested repeatedly reactive for the antibody to the Hepatitis B core antigen (anti-HBc), were distributed. MANUFACTURER/RECALLING FIRM: Northwest Lions Eye Bank, Seattle, WA RECALLED BY: The recalling firm by telephone on May 21, 2001, and letter dated June 7, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1835-1, Red Blood Cells, Unit Y28379 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL RECALLED BY: The recalling firm, by letter dated June 6, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1837-1, Platelets, Pheresis, Unit 03P23061 REASON: Blood product, collected in a manner that compromises the sterility of the unit, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Southern Region, Atlanta, GA RECALLED BY: The recalling firm by telephone on January 8, 2000, and by letter dated January 25, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: GA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1839-1, Platelets, Pheresis, Units 06KC39962 (parts A and B), 06KC38918, 06KC37933 REASON: Blood products, collected from a donor with a history of jaundice and having tested positive for hepatitis A, were distributed. MANUFACTURER/RECALLING FIRM: American National Red Cross, Southern California Region, Santa Ana, CA RECALLED BY: The firm, by letters dated April 18, 2000 and May 24, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 4 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1840-1, Platelets, Pheresis, Unit 3975474 REASON: Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed. MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood Center, Houston, TX RECALLED BY: The recalling firm, by facsimile on 12/11/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1841-1, Red Blood Cells, Leukoreduced, Unit 3791496 B-1842-1, Platelets, Unit 3791496 REASON: Blood products, collected from a donor who had traveled to an area designated as endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood Center, Houston, TX RECALLED BY: The recalling firm, by facsimile dated February 5, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1843-1, Platelets, Unit 3980141 REASON: Blood product, collected from a donor whose body temperature had not been documented, was distributed. MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood Center, Houston, TX RECALLED BY: The recalling firm, by telephone on December 19, 2000 and by facsimile on December 20, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1844-1, Source Plasma, Units 8YT139, 8YT429 REASON: Blood products, collected from a donor who had body piercing within twelve months of donation, were distributed. MANUFACTURER/RECALLING FIRM: Aventis Bio-Services, Inc., Oklahoma City, OK RECALLED BY: The recalling firm, by facsimile dated November 20, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1845-1, Red Blood Cells, Luekoreduced, Unit 15009-9950 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER: Blood Systems, Inc., Midland, TX RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by letter dated March 20, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Texas QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1847-1, Red Blood Cells, Leukoreduced, Unit 17194-2343 REASON: Blood product prepared from an overweight whole blood unit, was distributed. MANUFACTURER: Blood Systems, Inc., San Angelo, TX RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by telephone on March 8, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Texas QUANTITY: 1 unitRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1836-1, Red Blood Cells, Irradiated, Unit C36469 REASON: Blood product, which was stored at unacceptable temperatures, was distributed. MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank, Aurora, IL RECALLED BY: The recalling firm, by letter dated May 29, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1838-1, Red Blood Cells, Leukoreduced, Irradiated, Units 03L18545, 03FJ63625, 03FX24288, 03FJ63613, 03FX24334, 03FX24346 REASON: Blood products, which were stored at unacceptable temperatures, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Southern Region, Atlanta, GA RECALLED BY: The recalling firm, by telephone on October 6, 2000, and by letter dated November 2, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: GA QUANTITY: 6 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1846-1, Platelets, Pheresis, Leukoreduced, (unit 2 of a split unit), Unit 17194-0530. REASON: Blood product, that had been lost in shipment prior to return to the blood center, was redistributed. MANUFACTURER: United Blood Services, Lubbock Center, Lubbock, TX RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by letter dated June 4, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: Texas QUANTITY: 1 unitRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1082-1 Sterile product is packaged in a white Tyvek pouch labeled in part, “MacroPore Instrument***StarBurst Screw Driver***Sterile***Catalog No. 02090***LOT 50489***05- 2005***MacroPore Inc.***San Diego, CA 92121***”. Non-sterile product is packaged in a white Tyvek pouch labeled in part, “MacroPore Instrument***StarBurst Screw Driver***Non- Sterile***Catalog No. 02090***LOT 50489***05-2005***MacroPore Inc.***San Diego, CA 92121***”. Labeling for the product is labeled in part, “Instructions For Use***MacroPore Craniomaxillofacial (CMF) and Neurological (Neuro) Surgery Products***DESCRIPTION***INDICATIONS*** CONTRAINDICATIONS***WARNINGS AND PRECAUTIONS***STORAGE AND HANDLING*** POSSIBLE ADVERSE EFFECTS***PROCEDURE***CLEANING AND STERILIZATION*** CAUTIONS***MACROPORE***San Diego, CA 92121***”. CODES: Lot 50489, Exp Date 5/2005 REASON: False perception of sterility on part of users. MANUFACTURER/RECALLING FIRM: MACROPORE, INC. SAN DIEGO, CA RECALLED BY: Manufacturer, by Product Bulletin on 9/5/00 and letters dated 9/11/00 and 9/28/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 62RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-647-1 Laser Product/Custom Gaging System; Model name and number: Custom gaging system. REASON: The products did not comply with the warning logotype, aperture label, identification and certification label requirements. MANUFACTURER/RECALLING FIRM: Kurt Manufacturing Company, Minneapolis, MN RECALLED BY: Manufacturer, by visit or letter to be completed by November 30, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 5 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0844-1 Dynarad Model HF-110A Mobile X-Ray System; Codes: Model HF-110A, serial numbers 0101 through 1085 REASON: Cracks may occur in the yoke supporting the generator MANUFACTURER/RECALLING FIRM: Dynarad Corp., Deer Park, NY. RECALLED BY: Del Medical Imaging Corp., Franklin Park, IL., by letters dated 6/15/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, and International. QUANTITY: 662 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0845-1 - Z-0846-1 Multi-Therapy Ambulatory Infusion Pumps sold under the following labels: a) Sabratek 6060 Homerun Infusion Pump, product codes 606000-40 (English), 606000-40L (loaner pump), 606000-40I (International), 606000-41 (Spanish), 606000-42 (Portugal), 606000-43 (France), 606000-44 (JMS), 606000-45 (Sweden), 606000-46 (Dutch) and 606000-47 (German) b) Baxter 6060 Multi-Therapy Ambulatory Infusion Pump, product code 2M9832 CODES: All serial numbers with installed software V2.06.5 and lower, or V2.10.3 and lower (International version). REASON: The infusion pump may overinfuse in the PCA mode of operation. MANUFACTURER/RECALLING FIRM: Sabratek Corp. Skokie, IL. RECALLED BY: Baxter Healthcare Corp., by recall letters dated 5/10/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and International QUANTITY: 2000 – 4000 pumps _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0847-1 and Z-0848-1 Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151 and 2M8151R (refurbished); for continuous or intermittent fluid delivery through clinically acceptable routes of administration such as intravenous, intra-arterial, subcutaneous, epidural or irrigation of fluid spaces applications; Made in Singapore Codes: Product code 2M8151 and 2M8151R (refurbished), all units. REASON: Damaged power cord may result in arcing and potential burning MANUFACTURER/RECALLING FIRM: Baxter Healthcare PTE Ltd. Singapore, SN RECALLED BY: Baxter Healthcare Corp., I.V. Systems Division Round Lake, IL., by "Urgent Product Recall" letters dated 4/24/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 80,000 pumps _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0849-1 Medela BiliBed Phototherapy Lamp, Model 0383009; used for the treatment of newborns with neonatal jaundice (hyperbilirubinemia); Codes: Models 0383009, all serial numbers included in the ranges of 970933 through 972184 and 1000569 through 1004473 REASON: Failure of the internal housing fan allows temperature to rise around infant. MANUFACTURER/RECALLING FIRM: Medela A.G. CH-6340 Baar, SZ RECALLED BY: Medela, Inc. McHenry, IL, by letters dated 5/11/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, Canada and Mexico. QUANTITY: 575 lamps _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0850-1 FreshLook (phemfilcon A) Toric for Astigmatism Soft Contact Lenses with Handling Tint; the soft contact lenses are individually packaged in sterile foil-sealed plastic packages, 6 packs per box. Codes: Lot 127945, expiration 2003-08 REASON: Mislabeled for corrective power, cylinder & axis MANUFACTURER/RECALLING FIRM: Wesley Jessen Corporation, Des Plaines, IL RECALLED BY: Manufacturer, by letters dated 2/7/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, Canada, Australia and England. QUANTITY: 119 6-packs _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0851-1 ICON Profile Processing Software used on the ICON P workstations designed for use with E.CAM Gamma Camera Systems to conduct cardiac Tomo and SPECT applications; 60195-5203. Codes: All E.CAM gamma cameras with the Profile option with ICON-P workstations and ICON software revision 8.1 or greater REASON: Artifacts on images from profile scans MANUFACTURER/RECALLING FIRM: Siemens Medical Systems, Inc., Hoffman Estates, IL RECALLED BY: Manufacturer, There was no end user notification other than the statement "Please install ICON 8.5 (Rev. 02) software on all ICON P workstations which process Profile studies.", which was included in the "What's New for ICON 8.5" letter sent to ICON Users that was revised in February 2000. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: National and International QUANTITY: 125 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0852-1/Z-0854-1 Cellulose Diacetate Hemodialyzers; a single use sterile device for hemodialysis of patients with acute or chronic renal failure; 12 units per case; marketed under the following brand names: a) Mera Meltra Nova 110 Hemodialyzer Cellulose Diacetate-N Membrane, cat. #277-451G b) Altra Nova 170 Cellulose Acetate-N Hemodialyzer, cat. #201-472 c) Altra Nova 200 Cellulose Acetate-N Hemodialyzer, cat. #211-484G Manufactured by Althin Medical AB, 37221 Ronneby, Sweden d) Althin A-15 Althane Capillary Dialyzer, cat. #237-015 Codes: Meltra Nova Model 110, product code 277-451G, lot 451-980911C Altra Nova Model 170, product code 201-472, lots 472-980825A, 472-980923E, 472-981113B Model 200, product code 211-484G, lots 484-981009A, 484- 981009C, 484-981012B, 484-990224B, 484-990311A, 484-990318C A Series Althane Model 1.5, product code 237-015, lots 1998M02R, 1998M02R1, 1998M02Z REASON: Iritis patient reactions MANUFACTURER/RECALLING FIRM: Manufactured by Althin Medical, Inc., Miami Lakes, FL RECALLED BY: Baxter Healthcare Corp. Round Lake, IL , by letters dated May 24, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and International. QUANTITY: 37,901 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0855-1/Z-0856-1 E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Codes: a) E.CAM Dual Head Variable System Gantry part #4280221, serial #0005 to 1215 5242826, serial #1001 to 3079 b) E.CAM Single Head Camera Gantry part #4380213, serial #0001 to 3023 REASON: Potential loss of engagement in radial drives. MANUFACTURER/RECALLING FIRM: Siemens Medical Systems, Inc., Hoffman Estates, IL RECALLED BY: Manufacturer, no end user notifications were issued. A revision of NM004/00/S was issued on 7/5/01, correcting the affected serial number ranges. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, and International. QUANTITY: 541 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0857-1/Z-0858-1 RadWorks Software Version 5.1 with Software Patch 5 or 7, and RadWorks WebViewer Software Verion 5.1 running on RadWorks 5.1 Software Patch 5 or 7; picture archival and communications system; Applicare Medical Imaging B.V., Zeist, The Netherlands Codes: RadWorks Software Version 5.1 with Software Patch 5 or 7 and RadWorks Webviewer Software 5.1 running on RadWorks 5.1 Software Patch 5 or 7 REASON: Software anomaly causes image to be associated with wrong DICOM header MANUFACTURER/RECALLING FIRM: Applicare Medical Imaging, B.V. ZEIST, RECALLED BY: GE Medical Systems Information Technologies, Mt. Prospect, IL , by telephone on 3/8/01,and .by letters dated 3/6/01 and flagged "URGENT Safety Alert". FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide through nine distributors in New Jersey, Wisconsin, Nebraska, Texas, Illinois, Colorado and Ohio. QUANTITY: 3319 RadWorks 5.1 and 56 RadWorks WebViewer 5.1 licenses _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-866-1 Raven Prospore2 Biological Indicator Intended for Steam Sterilization (121 degrees C) Contains Bacillus stearothermophilus spores, packaged 50 tests per box; and Raven Prospore ii Biological Indicators (same product) packaged 10- tests per box. (NOTE: The label for the 10-test boxes is an old label which was in use for this lot.). CODE: Lot No. 455, exp. 9/2002 REASON: Inappropriate color change. MANUFACTURER/RECALLING FIRM: Raven Biological Laboratories, Inc. Omaha, NE RECALLED BY: Manufacturer, by Fax on 6/15/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CA, FL, TX, NJ, TN, MD, MI and France, Germany, Turkey, Sweden, Italy, Brazil, Japan, Argentina, Croatia, Peru, Spain, and the Netherlands. QUANTITY: 615/50-pack boxes and 40/10-pack boxes. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-867-1. VDRL Test Control Serum Set, Catalog No. 235201, Lot Nos. 149027LA and 149484LA; REASON: The VDRL Weakly Reactive Serum Control demonstrates reactivity comparable to or stronger than the VDRL Reactive Control Serum. The unexpected reactivity of the control invalidates the assay and the users cannot qualify the antigen present in the sample. MANUFACTURER/RECALLING FIRM: Becton Dickinson Microbiology Systems, Sparks, MD. RECALLED BY: Manufacturer, by letter, on 6/12/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, PRR, Singapore, Thailand, Korea, India, Paraguay, Belgium and firm affiliates. QUANTITY: 1374 sets _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0872-1 - Z-0879-1 Ash Split Catheter, Bio-Flex Continuous/CAVH, Duo-Flow XTP, Hemo-Cath, Soft Line, and Tesio Hemodialysis and Apheresis Catheters. These products are hemodialysis catheters; the three types affected are: long term (chronic), short term (acute) and femoral (hemofiltration) catheters. Codes: Long Term Catheters: Ash Split Cath Long Term Hemodialysis Catheter (10FR x 18CM) - catalog number ASPC18P - all lots; Ash Split Cath Long Term Hemodialysis Catheter (10FR x 24CM) - catalog number ASPC24P - all lots; Bio-Flex Tesio Long Term Hemodialysis Catheter (7FR) - catalog number PBF - all lots; Tesio Long Term Hemodialysis Catheter (7FR) - catalog number MCTC730K - all lots; Hemo-Cath Long Term Silicone Double Lumen Hemodialysis Catheter (8FR x 18CM) - catalog numbers SL18P and MCDLTSL18P - all lots; and Hemo-Cath Long Term Silicone Double Lumen Hemodialysis Catheter (8FR x 24CM) - catalog numbers SL24P and MCDLTSL24P - all lots. Short Term Catheters: Duo-Flow XTP Short Term Double Lumen Hemodialysis Catheter (9FR x 12CM) - catalog numbers XTP94CT and XTP94MT - all lots; Duo-Flow XTP Short Term Double Lumen Hemodialysis Catheter (9FR x 15CM) - catalog numbers XTP96CT and XTP96MT - all lots; Hemo-Cath Short Term Silicone Double Lumen Hemodialysis Catheter (8FR x 12CM) - catalog number SL12P - all lots; Soft-Line Short Term Double Lumen Hemodialysis Catheter (7FR x 10CM) - catalog number T74M - all lots; Soft-Line Short Term Double Lumen Hemodialysis Catheter (9FR x 12CM) - catalog numbers T94C and T94M - all lots; Soft-Line Short Term Double Lumen Hemodialysis Catheter (9FR x 15CM) - catalog numbers T96C and T96M - all lots; and Soft-Line Short Term Double Lumen Hemodialysis Catheter (9FR x 20CM) - catalog numbers T98C and T98M - all lots. Femoral Catheter: Continuous/CAVH Hemodialysi Catheter (5FR x 7.6CM) - catalog number MC5CAVH3 - all lots. REASON: Unapproved for pediatric use as stated in literature. MANUFACTURER/RECALLING FIRM: Medical Components, Inc., Harleysville, PA. RECALLED BY: Manufacturer, by fax and UPS overnight on 4/27/00 and 1/2/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, and Canada. QUANTITY: Unknown _______________________________ RECALL NUMBER, PRODUCT AND CODE: IVAC MedSystem III Infusion Pump: Z-899-1 - Model No. 2860 (110V); Z-900-1 - Model No. 2863 (110V); Z-901-1 - Model No. 2865 (220V); Z-902-1 - Model No. 2866 (220V); Z-903-1 - MiniMed MMT 9500 (110V). REASON: The motor drive is subject to premature wear which can cause alarms and error notices which may affect fluid delivery. MANUFACTURER/RECALLING FIRM: Alaris Medical Systems, Inc., San Diego, CA RECALLED BY: Manufacturer, by letter dated 4/20/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and International. QUANTITY: Undetermined. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Touch-Proof Leadwires, Black and Red Wire, Micro-Z Neuromuscular Stimulators: Z-904-1 Black Wire, Part No. 0-24-ML WBLK-0-0, Lot No. 99H007 Z-905-1 Red Wire, Part No. 0-24-ML WRED-0-0, Lot No. 99H008. REASON: A design flaw (untapered pins) may cause an intermittent failure to conduct electrical energy from the stimulator to the electrode. MANUFACTURER/RECALLING FIRM: Prizm Medical, Inc., Duluth, GA RECALLED BY: Manufacturer, by letter and phone on 11/3-4/99. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide & Israel & Chennal. QUANTITY: 214 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0906-1 Behring Coagulation System (BCS) software CODES: Model OVIO03, Version 2.2 REASON: Leak of piston pump valve introduces air bubbles. MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH Marburg RECALLED BY: Dade Behring, Inc., Newark, DE, by letter. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: NY, IL,and MI QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0907-1 Dimension RxL integrated chemistry system. Prostate Specific Antigen (PSA) Flex Reagent Cartridge. Codes: catalog number RF450. Lots: JS1284 exp. 10/11/01, IP1265 exp. 9/22/01, IR1265 exp. 9/22/01, HN1240 8/28/01, UA1207 exp. 7/26/01, UB1194 exp. 7/13/01, TC1174 exp. 6/23/01, FN1156 exp. 6/5/01, SA1125 exp. 5/5/01, DP1102 exp. 4/12/01, PC1087 exp. 3/28/01, CP1068 exp. 3/9/01, BM1045 exp. 2/14/01, AR1010 exp. 1/10/01, LS0344 exp. 12/9/00, and KM0327 exp. 11/22/00. REASON: False positive results - increased number. MANUFACTURER/RECALLING FIRM: Dade Behring, Inc., Newark, DE. RECALLED BY: Manufacturer, by letter on 11/20/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and to the following foreign countries: Venezuela, Denmark, Brazil, Austrailia, Guam, Canada, Hong Kong, Belgium, and China. QUANTITY: 10, 327 cartons _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0931-1 Medex Bifurcated Set, with SmartSite Valve, 25 sets per case. Codes: Lot Number: 31A2255849, Cat Number: MX20498 REASON: The device is labeled as Latex Free, however it actually contains latex. MANUFACTURER/RECALLING FIRM: Medex, Inc. Hilliard, OH RECALLED BY: Medex, Inc. Dublin, OH , by telephone on 3/7/2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY: 9 cases (225 sets) _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0939-1 - Z-0940-1 FlexiLab Laboratory Information System, Versions 5.23 and 5.3 with Microbiology Module. REASON: Incorrect printing of lab test results. MANUFACTURER/RECALLING FIRM: Sunquest Information Systens, Inc. Tucson, AZ RECALLED BY: Manufacturer, by two notices, PSN-01-L08 dated March 23, 2001 and CN-01- 07 dated April 16, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Denmark. QUANTITY: Undetemined _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0941-1 - Z-0942-1 FlexiLab Codes: v. 5.23 and 5.3 REASON: Incorrect data is filed to patient file. MANUFACTURER/RECALLING FIRM: Sunquest Information Systems, Inc. Tucson, AZ RECALLED BY: Manufacture, Product Safety Notice, PSN-01-L11, issued on April 10, 2001, FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and United Kingdom, and Denmark. QUANTITY: Undetermined _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0943-01 VidaMed Transurethral Needle Ablation (TUNA) System VTS PROVu ground pad Model Number(s): 7002 CODES: 510283 515179 519471 520314 REASON: Potential burn of a return electrode following a TUNA procedure. MANUFACTURER/RECALLING FIRM: Vidamed, Inc. Fremont, CA RECALLED BY: Manufacturer, by letter on May 3, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and International QUANTITY: 8,037 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0944-01 FluidSense FS-01 Infusion Pump Codes: Serial Numbers: 100302-102393 (not inclusive) REASON: Keyboard may malfunction with stuck keys or provide no response to touch MANUFACTURER/RECALLING FIRM: Mack Technologies, Westford, MA RECALLED BY: Fluidsense Corp. Newburyport, MA , by n 4/10/2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CA, FL, TN QUANTITY: 1109 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0950-01 Precision PCx Blood Glucose Test Strips Codes: P/N 98757-01, Lot Number: 118545 REASON: Assigned High and Normal Control Ranges are incorrect MANUFACTURER/RECALLING FIRM: MEDISENSE UK LIMITED ABINGDON, RECALLED BY: Abbott Laboratories, Inc. Bedford, MA., by telephone on 11/3/00 and by letter dated 11/1/00. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 3226 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0952-01 - Z-0953-01 GEM Premier 5300 GEM Premier Plus 5500 Codes: a) GEM Premier Model No. 5300. All serial numbers b) GEM Premier Plus Model 5500. All serial numbers REASON: Inaccurate pO2 reading MANUFACTURER/RECALLING FIRM: Instrumentation Laboratory Co. Ann Arbor, MI RECALLED BY: Instrumentation Laboratory Co. Lexington, MA., by voluntary recall notice on 8/23/00. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: Model 5300: 400 units Model 5500: 222 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0954-01 Symmetra I-125 Brachytherapy Sources Sealed source, Radionuclide Codes: Symmetra I-125 Brachytherapy Sources Lot # Labeled Activity Range Actual Activity Range B7012201033 .220 - .238 mCi .239 - .258 mCi Implanted B701240103 .220 - .238 mCi .124 - .135 mCi Returned B7010301026 .305 - .330 mCi .259 - .280 mCi Implanted B712200001 .305 - .330 mCi .331 - .388 mCi Implanted B712210001 .305- .330 mCi .331 - .358 mCi Implanted B712220001 .305 - .330 mCi .259 - .280 mCi Implanted B712290001 .305 - .330 mCi .259 - .280 mCi Implanted B701230102 .331 - .358 mCi .281 - .304 mCi Returned B712190001 .331 - .358 mCi .359 - .388 mCi Implanted B712110003 .359 - .388 mCi .389 - .421 mCi Implanted B712110004 .359 - .388 mCi .389 - .421 mCi Implanted B701050102 .389 - .421 mCi .281 - .304 mCi Implanted B701050103 .389 - .421 mCi .281 - .304 mCi Implanted B701080101 .389 - .421 mCi .281 - .304 mCi Implanted B701120103 .389 - .421 mCi .220 - .238 mCi Implanted B701120105 .389- .421 mCi .220 - .238 mCi Implanted B712280001 .305 - .330 mCi .259 - .280 mCi Calibration Seed (Disposed) REASON: Labeled with wrong activity levels MANUFACTURER/RECALLING FIRM: BEBIG ISOTOPENTECHNIK GMBH BERLIN, RECALLED BY: UROMED CORP. NORWOOD, MA, by telephone on 1/30/01. FIRM INITIATED RECALL: Completed DISTRIBUTION: NY, FL, TX QUANTITY: 1208 SEEDS _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0955-01 - Z-0957-01 a) Agilent Model M3500B Heartstream XLT Defibrillator, also labeled as: Laerdal Heartstart 4000 Model M5500B Dibrillator/Monitor b) Heartstream XL Model M4735A Defibrillator/Monitor CODES: a) S/N range: US00100100-US101521 b) S/N range: US00100100-US00100778 REASON: Defibrillator may shut down or fail to power on MANUFACTURER/RECALLING FIRM: Agilent Technologies Inc., Andover, MA RECALLED BY: Firm notified consignees on 2/5/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 1338 units Heartstream XLT, 566 Heartstream XL _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0958-01 - Z-0965-01 Superview Speedband Multiple Band Ligator and Injection Superview Speedband Multiple Band Ligator Sterile Codes: UPN Descriptor M00542250 Superview 5 Band, Box 1 Lot Numbers: 613110A, 628120A, 625090A, 619100A, 601110B M00542251 Superview 5 Band, Box Lot Numbers: 608110A, 614110A, 617110A, 628110B, 604120A, 613120A, 614120A, 628120B, 605011A, 615011A, 620090A, 602100A, 604100A, 617100A, 620100A, 625100B M00542280 Superview 8 Band, Box 1 Lot Numbers: 605011B, 602110A M00542281 Superview 8 Band, Box 2 Lot Numbers: 601120A, 604120B, 627120A, 615011B, 630100A, 601110A, 613110B, 615110A, 628110A M00542150 Injection Superview 5 band w/o Needle Lot Numbers: 603011B, 614100B, 618120A M00542350 Injection Superview 5 band with Needle Lot Number: 3706692 M00542180 Injection Superview 8 band w/o Needle Lot Numbers: 614100A, 618120B, 603011A M00542380 Injection Superview 8 band with Needle Lot Number: 3656041 REASON: Band ligator fails to deploy MANUFACTURER/RECALLING FIRM: MEDSOURCE TECHNOLOGIES NEWTON, MA RECALLED BY: Boston Scientific/Microvasive Endoscopy Div., Natick, MA., by letter on 2/09/01 via FedX. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Japan, Europe QUANTITY: 25,154 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Model Nos. 501-4, 501-5, 501-6 Series, Deluxe LaserStar 501-4002 Nd:Yag, Hi Performance LaserStar Model 501-4002HP and Standard LaserStar Model No. 501-4003 Nd:Yag; laser welding products which are not medical devices: Z-967-1 - Model No. 501-4xxx Series; Z-968-1 - Model No. 501-5xxx Series; Z-969-1 - Model No. 501-6xxx Series. REASON: The products failed to have a readily available remote interlock connector. MANUFACTURER/RECALLING FIRM: LaserStar Technology, Division of Crafford Precision Products Company, Riverside, RI RECALLED BY: Manufacturer, by letter to be completed by November 30, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and International QUANTITY: 395 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0970-1 - Z-0971-1 Wako Lyophilized Chemistry 2, Product Code 7707A, Lot 7707A01, MFD Mar-00, Exp Date 31 Mar 2003; Wako Lyophilized Chemistry 1, Product Code 1104A, Lot 7704A01, MFD Mar-00, Exp Date 31 Mar 2003. REASON: Unit recalled by component manufacturer due to positive for anti-HCV. MANUFACTURER/RECALLING FIRM: Bio-Rad Laboratories, Inc., Irvine, CA. RECALLED BY: Manufacturer, by letter dated January 10, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Japan QUANTITY: Unknown. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0972-1 - Z-0973-1 Plum A+ Infusion Pump List No. 11973 Plum A+ Peripheral Card List No. 12380-04-05/06 CODES: Abbott part number 11973 Abbott part number 12380-04-05/06 All lot/serial numners are involved. REASON: There is a potential for error in delivery if Duration is changed while in “Titration Mode”. MANUFACTURER/RECALLING FIRM: Abbott Laboratories Abbott Park, IL RECALLED BY: Abbott Laboratories, Hospital Products Division Morgan Hill, CA, by letters dated 4/2/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 4,060 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0975-1 Tosoh AIA-PACK brand Troponin I, Immunoassay Test Cups Codes: Lot Numbers: A719706; A919707; B119708; B319709 REASON: False positive and false negative results. MANUFACTURER/RECALLING FIRM: TOSOH MEDICS, INC. SOUTH SAN FRANCISCO, CA RECALLED BY: Manufacturer, by telephone and letters on July 25, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Canada, Chile and Mexico. QUANTITY: 399 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0979-1 TracheoSoft, 8.0mm Shiley, XLT Distal Extension – Tracheostomy tube and tube cuff. The product is an extended length tracheostomy tube that has a disposable inner cannula. It is available in four sizes V 5, 6, 7 and 8mm and four different SKUs. There are cuffed and uncuffed versions and proximal and distal versions of the above sizes. Only the 8.0mm Shiley TracheoSoft XLT with Distal Extension - Cuffed Tracheostomy Tube is the subject of this recall. CODES: Catalog Number: 73120-080, Lot Number: 2001-01-4470 REASON: Device components can become disconnected or dislodged, leading to ineffective ventilation. MANUFACTURER/RECALLING FIRM: Mallinckrodt Medical Athlone, Ireland, RECALLED BY: NELLCOR PURITAN BENNETT, INC. Pleasanton, CA , by telephone and letter on 4/17/01, with follow-up letter on 4/19/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: U.S., Canada, U.K., Germany, Austria, Italy, Spain, Ireland. and France QUANTITY: 560 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0980-1 - Z-0981-1 Hamilton Disposable Precision Tips, A Microlab AT Series A pipette CODES: Models: 235300, 235400 REASON: A defect in the molding of the tip barrel. MANUFACTURER/RECALLING FIRM: Hamilton Co., Reno, NV. RECALLED BY: Manufacturer, via letter on 3/8/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AZ, NC, and NJ. QUANTITY: 12 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0982-1 Dialysis Reverse Osmosis (RO) Water System, a water treatment system used in hemodialysis applications. CODES: The following RO serial numbers are affected by this recall: 97004, 97005, 97007, 97009-97019, 97021, 97024-97033, 97036, 97038, 97039, 97041-97043, 97045, 97048-97055, 97059, 97060-97066, 97069, 97070- 97080, 97082, 97084-97086, 97088, 97089, 97093, 97095-97096, 97100, 97102, 97106, 97109, 97112-97114, 97117, 97123, 97124, 97127-97129. REASON: The fuse holder may fail prematurely, heat up, and result in a potential fire. MANUFACTURER/RECALLING FIRM: AMERIWATER DAYTON, OH RECALLED BY: Firm issued a "Quality Advisory Notice", dated 2/17/1999, and a second notice and telephone call on 11/6/2000 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 85 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0983-1 FREEHAND System, Implantable Receiver-Stimulator (IRS) Electrodes for the NeuroControl FreeHand System. The system uses electrical muscle stimulation which is intended to improve a patient's ability to grasp, hold, and release objects. Codes: Serial Numbers: The five (5) units subject to recall were identified with the following Serial Numbers and Dates of Manufacture: Serial #92 and Serial #94, manufactured on 8/13/1996; and Serial Nos. 111, 114, and 115, manufactured on 1/29/1997. REASON: The electrode device may fail to deliver proper stimulation to the patient. MANUFACTURER/RECALLING FIRM: NEUROCONTROL CORP. VALLEYVIEW, OH RECALLED BY: Manufacturer, by telephone on 10/27 and 11/1/2000, and by letter dated 11/6/2000 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: PA and CA. QUANTITY: 5 units (not implanted) _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0984-1 STERIS 20 Sterilant Concentrate, used with the STERIS SYSTEM 1 PROCESS. STERIS 20 is packaged in a cup consisting of two parts: 35% peracetic acid liquid and a dry powdered formulation (sterilant builders). 20 cups per carton. Codes: Catalog # S2000. The following 36 Lot Numbers are recalled: A424-01024, A426-01024, A427-01024, A427-01027, A431-01027, A432-01027, A435-01027, A436-01027, A437-01027, A439-01027, A440-01027, A440-01103, A441-01103, A446-01103, A447-01103, A448-01103, A450-01103, A451-01103, A452-01103, A454-01103, A455-01108, A456-01108, A458-01108, A464-01108, A466-01108, A468-01114, A469-01114, A470-01114, A471-01114, A472-01114, A473-01114, A474-01114, A475-01114, A477-01114, A479-01114, and A480-01114. REASON: Metal particles may lodge in endoscope lumen and result in ineffective sterilization and/or may dislodge into patient during a surgical procedure. MANUFACTURER/RECALLING FIRM: STERIS CORP. MENTOR, OH RECALLED BY: FIrm mailed recall letters, dated January 16,2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Ntionwide and Canada QUANTITY: 23748 cases (474,960 cups) _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0985-1 - Z-0996-1 ENDOPATH Non-Bladed Obturator Trocar, with smooth or stability sleeve, handled or non-handled. Sizes: 5mm, 10/11mm, and 10/12mm. Lengths: 100mm and 75mm. The defective Trocars are packaged as 6 per single sales unit per box or 2 to 5 units per procedure kit/tray. Codes: All finished packaging lot numbers are recalled. The lot numbers consist of a 6-digit number. 5mm size: Distributed between December 1997 and December 2000, with expiration dates between December 2000 and November 2005. 10/11mm and 10/12mm sizes: Distributed between December 1997 and September 2000, with expiration dates between December 2000 and August 2005. The affected CATALOGUE NUMBERS [PRODUCT CODES] are as follows: Disposable Single Sales Unit, 5 mm [length 75 mm and 100 mm]: 35OL, 35HL, 35OS, 35HS, 35HST, 35NST, 35HLT, and 35NLT. Disposable Single Sales Unit, 10/11 mm [length 100 mm]: 511O, 511H, 511NT, and 511HT. Disposable Single Sales Unit, 10/12/mm [length 100 mm]: 512ON, 512HN, 512NT, and 512HT. Resposable Single Sales Unit, 5 mm [length 100 mm]: 355NA, and 35LNA. Resposable Single Sales Unit, 10/11 mm [length 100 mm]: 511HA, and 511NA. Resposable Single Sales Unit, 10/12 mm [length 100 mm]: 512HA, and 512NA. Laparoscopic Cholecystectomy Trays: All numbers beginning with: FD, FDO, FNA, FNC, KDC, KNC, and VNC. Laparoscopic Gastric Kits: All numbers beginning with: KNG, and FNG. Laparoscopic OB/GYN Trays: All numbers beginning with: FNO, and KN. Laparoscopic Hernia Trays: All numbers beginning with: FNH and KNH. Laparoscopic Access/Basic Trays: All numbers beginning with: KNA. Laparoscopic Bowel Trays: All numbers beginning with: KNB. REASON: The lens tip of the trocar may separate from the obturator during surgery. MANUFACTURER/RECALLING FIRM: ETHICON ENDO-SURGERY, INC. Ciudad Juarez Chihuahua,MEXICO, RECALLED BY: ETHICON ENDO-SURGERY, INC. CINCINNATI, OH, by Certified Mail on 9/25/2000 FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and Worldwide QUANTITY: 1,022,411 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0997-1 - Z-1022-1 Product Name / Catalog Number / Lot Number: 1) Premier CMV IgG; Cat # CME100 Lots: CME100.003, CME100.004, CME100.005 2) Premier CMV IgM; Cat # CME150 Lots: CME150.002, CME150.003, CME150.004 3) Premier EBV Early Antigen IgG; Cat # EAI101 Lots: EAI101.005, EAI101.007, EAI101.008 4) Premier EBV VCA IgG; Cat # EBE100 Lots: EBE100.004, EBE100.005, EBE100.008, EBE100.009,EBE100.010 5) Premier EBV VCA IgG SemiQuantitative; Cat # EBE101 Lots: EBE101.009, EBE101.011, EBE101.012 6) Premier EBV VCA IgM; Cat # EBE150 Lots: EBE150.005, EBE150.009, EBE150.011, EBE150.012 7) Premier EBV EBNA-1 IgG; Cat # ENE102 Lots: ENE102.004, ENE102.007, ENE102.008 8) Premier EBV VCA/EA IgM; Cat # EVE150 Lots: EVE150.005, EVE150.006 9) Premier HSV Type 1 IgM; Cat # H1E150 Lots: H1E150.008 10) Premier Type Specific HSV-1 IgG; Cat # H1I101 Lots: H1I101.008, H1I101.009 11) Premier Type Specific HSV-1 IgG; Cat # H1S100 Lots: H1S100.007, H1S100.008, H1S100.009 12) Premier HSV Type 2 IgM; Cat # H2E150 Lots: H2E150.004, H2E150.007, H2E150.008, H2E150.009, H2E150.010 13) Premier Type Specific HSV-2 IgG; Cat # H2I101 Lots: H2I101.005, H2I101.007, H2I101.008 14) Premier Type Specific HSV-2 IgG; Cat # H2S100 Lots: H2S100.005, H2S100.007 15) Premier Type Specific HSV-1 & 2 IgG; Cat # H3I101 Lots: H3I101.002, H3I101.003 16) Premier Lyme IgM; Cat # LDE150 Lots: LDE150.004, LDE150.005, LDE150.006 17) Premier Rubeola IgG; Cat # RBE100 Lots: RBE100.003, RBE100.004 18) Premier Rubeola IgM; Cat # RBE150 Lots: RBE150.004, RBE150.005 19) Premier Rubella IgG; Cat # RUE100 Lots: RUE100.004, RUE100.005 20) Premier Rubella IgM; Cat # RUE150 Lots: RUE150.002, RUE150.003 21) Premier Rubella IgG; Cat # RUE101 Lots: RUE101.003, RUE101.004 22) Premier Toxoplasma IgG; Cat # TXE100 Lots: TXE100.002, TXE100.003 23) Premier Toxoplasma IgG; Cat # TXE101 Lots: TXE101.001 24) Premier Toxoplasma IgM; Cat # TXE150 Lots: TXE150.001, TXE150.002 25) Premier VZV IgG; Cat # VZE101 Lots: VZE101.005, VZE101.006 CODES: All lot numbers still within expiration dates. REASON: The kits are not properly validated, which may give variable or inaccurate test results. MANUFACTURER/RECALLING FIRM: MERIDIAN DIAGNOSTICS, INC. CINCINNATI, OH RECALLED BY: The firm issued a recall notification by FedEx on 3/9/2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and Italy, Canada, Columbia, Mexico, New Zealand, Philippines, Costa Rica, Panama, Germany, Belgium, West Indies, Australia, Venezuela, and Switzerland. QUANTITY: 20,286 kits _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1022-1 2.4mm Locking Screws, component/accessory of the Osteomed Rigid Fixation System - Mandibular Frature/Reconstruction System. Codes: Recalled accessory is not coded on the packaging. Part Number Lot Number Qty 206-0206 994262 204 206-0208 884263 205 206-0210 994264 392 206-0212 994265 404 206-0214 994266 407 206-0218 994268 200 206-0216 994267 209 206-0220 994269 204 206-0222 994270 208 REASON: The locking screw can fracture/break during surgical procedure. MANUFACTURER/RECALLING FIRM: OSTEOMED CORP. ADDISON, TX RECALLED BY: Manufacturer, by letter dated 4/28/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: Canada, Norway QUANTITY: 2434 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1027-1 - Z-1030-1 a) Aaron Ball Electrode, 5mm; b) PSS Ball Electrode 5mm; c) Sklar Ball Electrode 5mm; d) Apple Medical Ball Electrode 5 mm. CODES: a) Cat. Number ES07, Lot Numbers 2000-11-09, 2000-11-30 and 2000-12-14; b) Cat Number 465, Lot numbers 1100-B, 1200-B and 0101-B c) Catalog Number 96-1045, Lot Number 0101-A, d) Catalog Number 900-163, Lot numbers 1000-D, 1100-D and 0101-B. REASON: Electrode fell apart during use. MANUFACTURER/RECALLING FIRM: Aaron Medical Industries, St. Petersburg, FL RECALLED BY: Manufacturer, by letter on 2/26/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, and Canada, New Zealand, and Spain QUANTITY: 4,249 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1031-1/ Clinitron At-Home Air Fluidized Therapy Codes: Model CS (also identified as model #C-6) - All serial numbers REASON: Power cords overheating, smoking, or melting during normal operations. MANUFACTURER/RECALLING FIRM: Hill-Rom, Inc. Charleston, SC RECALLED BY: Manufacturer, Power cords were sent via UPS to every patient's home for replacement. Additionally, all service centers received an inventory of cords to replace all units presently located in their service location. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 2873 units (1799 in patient homes & 1074 in service centers) _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1033-1/ VasoSeal VHD Device Bascular Hemostasis device Catalog number 75304 CODES: VasoSeal VHD Device, Kit #4 Device Listing: A063825 Catalog Number 75304 Manufacturing Lot Number:03051172 REASON: Portion of VasoSeal VHD lot shipped prior to receipt of complete pyrogen testing. MANUFACTURER/RECALLING FIRM: Datascope Corp. Collagen Products Division Mahwah, NJ RECALLED BY: Manufacturer, by letter on March 19, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 180 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1034-1 - Z-1041-1 Datascope's Percor STAT-DL and True Sheathless 9.5 Fr.Intra-Aortic Balloon Catheter for optional Sheathless Insertion. CODES: Product Numbers: 0684-00-0255-0X, 0884-00-4031-0X, 0684-00-0256-0X, 0684-00-0270-0X; 0884-00-3431-0X, 0684-00-0343-0X, 0784-00-0138-0X, 0884-00-2513-0X Lot Identification: 995, 996, 997, 997A REASON: Defect in the Y-fitting component which could cause slow gas leak. MANUFACTURER/RECALLING FIRM: DataScope Corp. Fairfield, NJ. RECALLED BY: Manufacturer, by Certified mail and registered mail on April 30, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: National and International QUANTITY: 590 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1042-1 Valleylab LigaSure vessel sealing system, CODES: Catalog Number: LS1000, Lot ANH000503. REASON: Previously recalled product, not released for distribution, was distributed. MANUFACTURER/RECALLING FIRM: Valleylab, Inc., Boulder, CO RECALLED BY: Manufacturer, by letters dated 05/04/2001 FIRM INITIATED RECALL: Completed DISTRIBUTION: CA, CO, and PA QUANTITY: 18 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1043-1 All products bearing the Hydrocath trademark. Products manufactured from 1996 until 1998 were labeled as Ohmeda Hydrocath Central Venous Catheters. In 1998, BD acquired Ohmeda and labeling will indicate BD Hydrocath Central Venous Catheters. CODES: Becton Dickinson reference numbers 681173 thru 681222, 681275 thru 681278. All catheters labeled as BD Hydrocath or Ohmeda Hydrocath. REASON: Immediate-type hypersensitivity reactions, primarily in pediatric/infant patient MANUFACTURER/RECALLING FIRM: BD Critical Care Systems PTE LTD Singapore, RECALLED BY: Becton Dickinson Infusion Therapy Systems, Inc. Sandy, UT, by letter on 5/9/2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Mexico, Japan, and other European countries not yet furnished. QUANTITY: Approximately 2,135,000 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1044-1 - Z-1045-1 a) Kendall SCD Clear Sequel/SCD Response Tubing Assembly used with Model 6325 and 7325; b) Kendall SCD Blue Quick-Lock Tubing Assembly used with Models 5320 and 5325 CODES: a) Product Code: 6328 Lot Numbers: 118761, 118762, 118763, 119574 b) Product Code: 5378A Lot Number: 119571 REASON: Tubing Assemblies assembled incorrectly and compression sleeves may not inflate properly. MANUFACTURER/RECALLING FIRM: THE KENDALL CO. LP ARGYLE, NY RECALLED BY: THE KENDALL CO. LP MANSFIELD, MA, by letter on 6/19/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: #6328= 590 eaches; #5378=7 eaches _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1046-1 Lifescan brand One Touch Hospital Blood Glucose Test Strips, 50-count test strips in a package. CODES: Lot 009894A, Exp. Date: 09/02 REASON: The product was assigned an incorrect calibration code (“calcode”). MANUFACTURER/RECALLING FIRM: LifeScan, Inc, Milpitas, CA RECALLED BY: Manufacturer, by letters on May 31, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 2224 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1048-1 Medusa 2000 MED20SP Link Software Versions 1.2 and 1.3 The software Medusa 2000 is an interface link to the Ortho Summit Processor (OSP) which is a mass processing device for microplate based assays [tests for viral markers by ELISA]. The software is responsible for conveting OSP files into a format for use by Medusa 2000. CODES: Medusa 2000 MED20SP Link Software Versions 1.2 and 1.3 REASON: Software may process result instead of invalidating the plate MANUFACTURER/RECALLING FIRM: SANGUIN INTL., INC. STAFFORDSHIRE DE 13 8AX, RECALLED BY: SANGUIN INTL., INC. HAMDEN, CT, by letter on 6/12/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AL and TN QUANTITY: 2 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1049-1 Acuity Central Monitoring Stations with software versions 4.03.00, 4.03.01, 4.03.02, 4.03.03, 4.03.04, and 4.03.05 when connected to VHF/UHF telemetry units CODES: software versions 4.03.00, 4.03.01, 4.03.02, 4.03.03, 4.03.04, and 4.03.05 REASON: Incorrect Visual Display MANUFACTURER/RECALLING FIRM: WELCH ALLYN PROTOCOL, INC. BEAVERTON, OR RECALLED BY: Manufacturer, by letter dated March 13, 2001 and May 28, 2001 and by telephone on June 18, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Netherlands, France, and Canada QUANTITY: 198 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1050-1 - Z-1052-1 AutoSuture [Single use Staplers]as follows: CODES: a) ILA* 75-3. 8 Order Code 4914 Affected Lot Numbers: P0M456, P1A104, P1A132, P1A199, P1B246, P1B247, P1C382, P1C592, P1C615, P1C680, P1E96, P1B248R b) ILA* 75-4.8 Order Code 4916 Affected Lot Numbers: P1A166, P1A273, P1D66 c) ILAN* 75-4.8 (Non anastomotic) Order Code 4917 Affected Lot Number: P1A390 REASON: Stapler may fire without the staples being completely formed into the tissue MANUFACTURER/RECALLING FIRM: USSC Puerto Rico, Inc. Mercedita, PR RECALLED BY: United States Surgical Corp. North Haven, CT, by letter on 7/12/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Canada, Japan, Korea, Singapore, Switzerland, Austria. QUANTITY: 7967 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1053-1 Maquet Alphamaxx Surgical Tables, Model 1133 CODES: Serial Numbers 11, 12, 14, 16, 17, 18 REASON: Table did not elevate when the Table-Up function was activated MANUFACTURER/RECALLING FIRM: Maquet Aktiengesellschaft Rastatt, Germany, RECALLED BY: Getinge/Castle, Inc. North Charleston, SC, by a Product Safety Notification on July 25, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CA, CO and IL. QUANTITY: 13 tables _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1054-1 Maquet Surgical Table, Model C-Max CODES: AR001011, AR001012, AR001013, AR001014, AR001015, AR001016, AR001017, AR001018, AR001019, AR001020, AR001021, AR001022, AR001024, AR001026, AR001027, AR001028, AR001029, AR001030, AR001031, AR001032, AR001033, AR001034, AR001035, AR001036, AR001037, AR001038 REASON: There is a potential of allowing the patient's head to drop. MANUFACTURER/RECALLING FIRM: ALM Orleans CEDEX 2, France, RECALLED BY: Getinge/Castle, Inc. North Charleston, SC, a Product Safety Notification was sent on 7/25/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: GA, MD, PA, TN, TX & WA QUANTITY: 26 tablets _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1056-1 Respironics Noninvasive Extrathoracic Ventilator NEV-100 CODES: NEV-100(Noninvasive Extrathoracic Ventilators), all serial numbers manufactured between 4/1992 and 2/1999. REASON: Faulty RFI filter may cause device to stop, reset and/or exhibit a smoky odor. MANUFACTURER/RECALLING FIRM: Respironics Colorado, Inc. Westminster, CO RECALLED BY: Manufacturer, by letter on 5/24/1999 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Australia, Brazil, Canada, China, Egypt, France, Germany, Greece, India, Italy, Japan, Korea, Mexico, and Taiwan. QUANTITY: 448 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1057-1 Acuity Central (Monitoring) Station CODES: FW03140982 through FW04330603 and TW03049094 through TW03049286 REASON: System crashes and lock-up. MANUFACTURER/RECALLING FIRM: Welch Allyn Protocol, Inc. Beaverton, OR RECALLED BY: Manufacturer, by letter dated 6/1/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AZ, CA, DE, IN, KY, NC, NJ, OH, PA, and TX. Singapore, Belgium, Egypt, Poland, New Zealand QUANTITY: 43 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1058-1 Siemens Compressor Compact,115V/60Hz CODES: Part Number: 61 50 440 EH81E, Serial numbers: 20001-20962 tREASON: Defective clutch in the compressor may result in low pressure alarm or noisy units MANUFACTURER/RECALLING FIRM: Siemens Elema AB/Electromedical Division SOLNA, RECALLED BY: Siemens Medical Systems, Inc. Danvers, MA, by Update Instruction EM002/01/1 on 6/28/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 854 units clutch replacement/972 units for F3 Fuse _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1061-1/ - Z-1066-1 Catheter Innovations PASV Implantable Port (plastic) Single or Dual port. CODES: Catalog No's: PRTC66P, PRTC96P, PRTD10P, PRTC66A, PRTC96A, PRTD10A. All lots. REASON: Implantable plastic catheter ports may leak due to cracking. MANUFACTURER/RECALLING FIRM: Catheter Innovations, Inc. Salt Lake City, UT RECALLED BY: Manufacturer, by fax and registered mail, on 02/02/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and Belgium, Canada, Italy, UK, and Turkey. QUANTITY: 180 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1067-1 Enteral Feeding Tube, Preassembled with Stylet, size 10 French 45 inch (114 cm), non-sterile, 10 feeding tube units per case. CODES: Lot Numbers: 59233ZU01, 60273ZU01, 62020ZU01. Ross List Number: 55041. REASON: Stylet may extend beyond the tip of the tube and cause tissue damage. MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc., Laurinburg, NC RECALLED BY: Ross Products Division, Abbott Laboratories, Inc. Columbus, OH on 3/27/2001, by telephone and by Federal Express letter FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 303 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1068-1 - Z-1069-1 Bard Access Opti-Flow Pre-Curved Dual Lumen Catheters, and Bard Access Opti-Flow Straight Chronic Dual Lumen Catheters CODES: All of the following are "Opti-Flow" dual lumen catheters. TRAYS 5636192 "Pre-Curved" 19 cm Insertion Length with VitaCuff Lots 36HK0035, 36IK0077, 36KK0065 5636232 "Pre-Curved" 23 cm Insertion Length with VitaCuff Lot 36LJ0066 KITS 5634150 "Pre-Curved" 15 cm Insertion Length Lot 22JKA184 5634152 "Pre-Curved" 15 cm Insertion Length with VitaCuff Lots 22BLA627, 22JKA179 5634190 "Pre-Curved" 19 cm Insertion Length Lots 22ALA621, 22DKA129 5634192 "Pre-Curved" 19 cm Insertion Length with VitaCuff Lots 22AKM021, 22AKM022, 22ALA617, 22LJM005, 22DKA125, 22DKA131, 22FKA139, 22GKA146, 22GKA147, 22HKA162, 22HKA165, 22JKA178, 22AKM024. 5634230 "Pre-Curved" 23 cm Insertion Length Lots 22FKY005, 22FKY006, 22HKA159, 22HKA163, 22JKA194. 5634232 "Pre-Curved" 23 cm Insertion Length with VitaCuff Lots 22BLY030, 22EKA132, 22EKA134, 22FKY003 22GKA140, 22LKA609. 5634270 "Pre-Curved" 27 cm Insertion Length Lots 22JKA188, 22KKA199. 5634272 "Pre-Curved" 27 cm Insertion Length with VitaCuff Lot 22IKA169. CATHETERS ONLY 5632150 "Pre-Curved" 15 cm Insertion Length Lot 22JKA183. 5632190 "Pre-Curved" 19 cm Insertion Length Lots 22HKA158, 22DKA128, 22GKY009. 5632192 "Pre-Curved" 19 cm Insertion Length with VitaCuff Lot 22HKA161. 5632230 "Pre-Curved" 23 cm Insertion Length Lot 22LJM010. 5632232 "Pre-Curved" 23 cm Insertion Length with VitaCuff Lot 22LJM012. 5632270 "Pre-Curved" 27 cm Insertion Length Lot 22AJK189. TRAYS 5635692 "Straight" 19 cm Insertion Length with VitaCuff Lots 36AKO036, 36HKO036, 36IKO070. 5635732 "Straight" 23 cm Insertion Length with VitaCuff Lots 36BLO051, 36LJO048, 36JKO064. KITS 5633150 "Straight" 15 cm Insertion Length Lots 22ALA127, 22JKA181. 5633152 "Straight" 15 cm Insertion Length with VitaCuff Lot 22JKA180. 5633270 "Straight" 27 cm Insertion Length Lots 22BLA629, 22JKA191, 22KKA603. 5633272 "Straight" 27 cm Insertion Length with VitaCuff Lot 22JKA192. 5633690 "Straight" 19 cm Insertion Length Lots 22EKA135, 22LJM006, 22FKY004. 5633692 "Straight" 19 cm Insertion Length with VitaCuff Lots 22KJM002, 22EKA202, 22DKA126, 22EKY002, 22FKA137, 22GK3439, 22GK3440, 22HJM707, 22HJM708, 22HKA152, 22IKA171. 5633730 "Straight" 23 cm Insertion Length Lots 22ALA620, 22DKA123, 22IJM726, 22LJM007. 5633732 "Straight" 23 cm Insertion Length with VitaCuff Lots 22BLA631, 22LJM017, 22DKA127, 22EKA200, 22EKY001, 22FKA136, 22FKA138, 22HKA156, 22IJM734, 22IKA167, 22IKA174, 22LJM009, 22LJM016. CATHETERS ONLY 5631550 "Straight" 15 cm Insertion Length Lot 22JKA182. 5631690 "Straight" 19 cm Insertion Length 22DKA124. 5631692 "Straight" 19 cm Insertion Length with VitaCuff Lot 22EKA201, 22LJM011. 5631730 "Straight" 23 cm Insertion Length Lots 22GK3454, 22HKA154. 5631732 "Straight" 23 cm Insertion Length with VitaCuff Lot IJM733. 5631770 "Straight" 27 cm Insertion Length Lots 22JKA190, 22GKY007, 22GKY008. 5631850 "Straight" 35 cm Insertion Length Lots 22JKA185, 22CKA111, 22EKA133, 22KKA602. REASON: Catheter tips may separate during use. MANUFACTURER/RECALLING FIRM: Medron, Inc. Salt Lake City, UT RECALLED BY: Bard Access Systems, Salt Lake City, UT, by recall packets via Fedex on 3/27/2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide to all states except ME and VT. Foreign distribution to Canada and Australia. QUANTITY: 47,757 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1070-1 Medex 60-inch Low-Vol Extension Set with Female Luer Lock, Male Luer Lock, and Non-Removable Slide Clamp. The product is packaged as 50 units per case, and labeled in part, ' ** Medex - A Furon Company Hilliard, OH 43026 USA ** PRODUCT 536035 ** 60in/152cm Ext. W/M/FLL Clamp APV 1.0 ml ** Latex Free ** STERILE ** ' CODES: Lot Number: 31A290143 REASON: The immediate container is labeled with the incorrect product number/priming volume. MANUFACTURER/RECALLING FIRM: Medex, Inc. Hilliard, OH RECALLED BY: Medex, Inc., Dublin, OH, by telephone and facsimile on 6/12/2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 200 cases (10,000 units) _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1071-1 Amsco Reliance 444 Washer-Disinfector, single-chamber. CODES: Serial Numbers: 3601900003, 3601900004, 3604100008, 3605901035, and 3609401004. REASON: An electrical shock hazard may exist due to improper ground wiring. MANUFACTURER/RECALLING FIRM: STERIS CANADA CORP. BEAUPORT, QUEBEC, RECALLED BY: STERIS CORP. MENTOR, OH, by letters, dated 7/12/2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: NY, PA, NJ, and DE. QUANTITY: 5 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1073-1 AutoDose Pump, Model P4120, an External Infusion Pump CODES: The firm provided a list of serial numbers affected but they are nonsequentially assigned to various consignees. REASON: Rollers in pump may pinch fingers of caregiver. MANUFACTURER/RECALLING FIRM: Tandem Medical San Diego, CA RECALLED BY: Firm's Recall was initiated on July 24, 2001 by letter. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 249 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1074-1 - Z-1077-1 FluidSense Sterile Administration Sets as follows: The sets are used with the FluidSense Fluid Delivery System [FS-01]. CODES: ES-O5 Secondary Administration Set -P/N 100324 ES-06 Large Volume Extension Set- P/N 100325 ES-07 Large Volume Administration Set- P/N 100326 ES-08 Low Contain Volume (Pedatric) Adminstration P/N 102191 All lots REASON: Core Y-Site may separate from plastic housing and dislodge MANUFACTURER/RECALLING FIRM: Elcam Paltics Merom Hagali, Israel RECALLED BY: Fluidsense Corp. Newburyport, MA., on 5/31/01 by e E-maile. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CA, FL, TN, QUANTITY: 19,840 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1078-1 Clinical Information Center Software. The brand name was Marquette when the product was initially distributed. CODES: All devices with V.2 and later revisions of the software. REASON: Device can improperly restart resulting in no alarms or information at the central station for 2 minutes. MANUFACTURER/RECALLING FIRM: GE Medical Systems, Information Technologies, Milwaukee, WI RECALLED BY: Manufacturer, by letter dated June 7, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and worldwide. QUANTITY: 645 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1082-1 StarBurst Screw Driver. This medical device is a screwdriver designed for use with the firm’s MacroPore System. The MacroPore System consists of resorbable implants and accessories for bone healing applications. The catalog numbers affected are 02090. The devices from this catalog number were sold in sterile and non-sterile forms. Only the sterile units were subject to the removal. REASON: False perception of sterility on part of users. MANUFACTURER/RECALLING FIRM: MACROPORE, INC. SAN DIEGO, CA RECALLED BY: Manufacturer, by Product Bulletin on 9/5/00 and letters dated 9/11/00 and 9/28/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 62 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1083-1 - Z-1084-1 Allograft Heart Valve CODES: Model No. AV05 - Serial Number 3877299 Model No. PV05 - Serial Number 3871398 REASON: Failure to meet curent guidelines regarding serodilution of plasma. MANUFACTURER/RECALLING FIRM: CRYOLIFE, INC. KENNESAW, GA RECALLED BY: Manufacturer, by letter on 6/23/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: MD and OK QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1086-1 - Z-1087-1 Polysynthane Hemodialyzers; 24 units per case; The products were distributed under both the Baxter label: Baxter Healthcare Corporation, Renal Division, Deerfield, IL 60015, and the Gambro label: the following models are affected: a) Model PSN-170, 1.7 m2 surface area x 229 mm length product code 5M1817 - Baxter label, global multi-language 5Q6123 - Baxter Japanese label 5M4117 - Gambro label b) Model PSN-210, 2.1 m2 surface area x 229 mm length product code 5M1818 - Baxter label, global multi-language 5Q6124 - Baxter Japanese label 5M4118 - Gambro label Codes: All lots of the PSN 170 and PSN 210 dialyzers a) Model PSN-170, 1.7 m2 surface area x 229 mm length product code 5M1817 - Baxter label, global multi-language 5Q6123 - Baxter Japanese label 5M4117 - Gambro label b) Model PSN-210, 2.1 m2 surface area x 229 mm length product code 5M1818 - Baxter label, global multi-language 5Q6124 - Baxter Japanese label 5M4118 - Gambro label REASON: Fiber blood leaks MANUFACTURER/RECALLING FIRM: BAXTER HEALTHCARE CORP. MOUNTAIN HOME, AR RECALLED BY: BAXTER HEALTHCARE CORP. DEERFIELD, IL, by letters dated 4/4/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Canada, Ecuador, Greece, Venezuela, Colombia, Belgium, Sweden, Mexico, Australia, Argentina, Shanghai and Germany QUANTITY: 1,239,047 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1088-1/Z-1092-1 Medtronic Activa Tremor Control Systems, also called Medtronic Activa Systems For Deep Brain Stimulation (DBS). Each consists of a neurostimulator or pulse generator, an extension, and a lead, which are used for the treatment of tremor due to Parkinson's Disease and Essential Tremor. Identified below are the specific pulse generators, extensions, and leads that can be used: Medtronic Generators Itrel I, II and 3 Implantable Pulse Generators Models 7420, 7421, 7424, 7425. Medtronic Soletra Quadripolar Neurostimulator for Deep Brain Stimulation, Model 7426 Medtronic Model 7495 DBS Extension For Stimulation of the Brain, Codes: All lots and serial numbers REASON: Using diathermy to treat patients with neurostimulation devices can cause injury MANUFACTURER/RECALLING FIRM: MEDTRONIC, INC. MINNEAPOLIS, MN RECALLED BY: On 5/16/2001, the firm sent a "Safety Alert" to physicians who implanted or are monitoring patients with Medtronic Neurostimulation Systems. Another Safety Alert, dated 5/18/2001, will be sent to patients who have the systems implanted. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and worldwide QUANTITY: An estimated 65,000 patients (6500 DBS patients) have Medtronic neurostimulation devices. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1093-1 - Z-1094-1 Becton Dickinson Saf-T-Intima IV Catheter. Catalog No. 383323, Lot 101322, and Catalog No. 383336, Lot 101328 and 101329. Codes: Catalog Number 383323, Lot 101322. Catalog Number 383336, Lot 101328, 101329 REASON: The telescoping needle shield would not function as designed due to improper epoxy application during manufacture. As a needle is withdrawn, the needle shield is supposed to telescope over the needle to prevent the possibility for needle sticks. MANUFACTURER/RECALLING FIRM: Becton Dickinson Infusion Therapy Systems Inc. Sandy, UT RECALLED BY: Manufacturer, on 3/16/2001, by letters. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 9,200 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1095-1 - Z-1099-1 a) Codman SiphonGuard CSF Control Device S/N 883944 b) CodmanHakim Programmable Valve, In-Line Reservoir Separable Distal Catheter with SiphonGuard Device c) CodmanHakim Programmable Valve, with Right Angle Reservoir, Separable Distal Catheter with SiphonGuard Device d) CodmanHakim Programmable Valve, In-Line Reservoir Unitized Distal Catheter with SiphonGuard Device e) CodmanHakim Programmable Valve with Right Angle Reservoir Unitized Distal Catheter with SiphonGuard Device CODES: a) Catalog # 82-3090 [Stand-Alone] b) Catalog # 82-3132 Lot numbers: beginnning with PP, PN c) Catalog # 82-3136 Lot numbers: beginnning with PP, PN d) Catalog # 82-3142 Lot numbers: beginnning with PP, PN e) Catalog 3 82-3146 Items B-D are serialized, all serial numbers begin with PP or PN REASON: Device may activate at lower than intended flow rates MANUFACTURER/RECALLING FIRM: SARL CODMAN LELOCLE SWITZERLAND, RECALLED BY: CODMAN & SHURTLEFF INC RAYNHAM, MA, by FED'X letter on 5/8/01 and 5/17/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Australia, Egypt, New Zealand, Spain, UAE, England QUANTITY: 215 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1100-1 - Z-1105-1 Brand Name: Dall Miles Vitallium Cable Crimp Sleeve Common Name:Cable Crimp Sleeve Classification Name:Appliance, fixation, nail/blade/plate combination Multiple Component Codes: Part Number Description 6704-0-410 Small Vitallium Cable Sleeve Plus 1.6mm Cable Lot # ILUX01, ILUY01, ILUZ01, ILVA01, ILVB01, ILVC01, ILVD01, IMDMO1, IMDN01, IMDO01, IMDP01, IMDR01, IMDS01, 6704-0-420 Small vitallium Cable Sleeve Plus 1.6mm Beaded Cable Lot # ILUP01, ILUR01, ILUS01, ILUT01, ILUU01, ILUV01, ILUW01, IMAF01, IMAG01, IMAH01, IMAI01, 6704-0-510 Medium Vitallium Cable Sleeve Plus 2.0mm Cable Lot # ILPO01, ILPP01, ILRF01, IJMA01, IJMB01, IJMC01, IJMD01, IJME01, ILLW01, ILNU01, ILNV01, ILNW01, ILNX01, ILNY01, ILNZ01, ILOA01, ILPJ01, ILPK01, ILPL01, ILPM01, ILPN01, ILRG01, ILRH01, ILRI01, ILRJ01, ILRK01, ILRL01, ILRZ01, ILSA01A,ILSB01, ILSC01, ILSD01, ILSE01, ILSF01, ILSV01, ILSWO1, ILSX01, ILSY01, ILSZ01, ILTA01, ILTB01, ILUA01, ILUB01, ILUC01, ILUD01, ILUE01, ILUF01, ILUG01, ILWS01, ILWT01, ILWU01, ILWW01, ILWX01, ILWY01, ILXA01, ILXB01, ILXC01, ILXD01, ILXE01, ILXF01, ILXG01, ILYN01, ILYO01, ILYP01, ILYR01, ILYS01, ILYT01, ILYU01, ILYV01, ILYW01, ILYX01, ILYY01, ILYZ01, ILZA01, ILZB01, ILZR01, ILZS01, ILZT01, ILZU01, ILZV01, ILZW01, ILZX01, IMBE01, IMBF01, IMBG01, IMBH01, IMBI01, IMBJ01, IMBK01, IMBT01, IMBU01, IMBV01, IMBW01, IMBX01, IMBY01, IMBZ01, IMDF01, IMDG01, IMDH01, IMDI01, IMDJ01, IMDK01, IMDL01, IMEO01, IMEP01, IMER01, IMES01, IMET01, IMEU01, IMEV01, IMFD01, IMFE01, IMFF01, IMFG01, IMFH01, IMFI01, IMFJ01, IMHC01, IMHD01, IMHE01, IMHJ01, IMHK01, IMHL01, IMHR01, IMHS01, IMHT01, IMHU01, IMHV01, IMHW01, IMHX01, IMJI01, IMJJ01, IMJK01, IMJL01, IMJM01, IMJN01, IMJO01, 6704-0-520 Medium Vitallium Cable Sleeve Plus 2.0mm Beaded Cable Lot # ILLN01, ILLO01, ILLR01, ILLS01, ILLT01, ILLU01, ILNM01, ILNN01, ILNO01, ILNP01, ILNR01, ILNS01, ILNT01, ILPR01, ILPS01, ILPT01, ILPU01, ILPV01, ILPW01, ILRS01, ILRT01, ILRU01, ILRV01, ILRW01, ILTX01, ILRY01, ILTC01, ILTD01, ILTE01, ILTF01, ILTG01, ILTH01, ILTI01, ILUI01, ILUJ01, ILUK01, ILUL01, ILUM01, ILUN01, ILUP01, ILXH01, ILXI01, ULXJ01, ILXK01, ILXL01, ILXM01, ILXN01, ILZY01, ILZZ01, IMAA01, IMAB01, IMAC01, IMAD01, IMAE01, IMBL01, IMBM01, IMBN01, IMBO01, IMBP01, IMBR01, IMBS01, IMCA01, IMCC01, IMCD01, IMCE01, IMCF01, IMCG01, IMEW01, IMEX01, IMEY01, IMWZ01, IMDW01, IMDX01, IMDY01, IMFK01, IMFL01, IMFM01, IMFN01, IMFO01, IMFP01, IMFR01, IMHF01, IMHG01, IMHH01, IMHI01, IMHM01, IMHN01, IMHO01, IMHP01, IMIU01, IMIV01, IMIW01, IMIX01, IMIY01, IMIZ01, IMIJA01 6704-4-016 Small Cable Sleeve 1.6mm Lot # CCAEBH 6704-4-020 Medium Cable Sleeve 2.0mm Lot# CAUUF, CAUUH, CAUUI, CAUUJ, CAUUK, CAUUM, CAUUN, CAUUO, CAUUG, CAUUP, CAUUR, CAUUS, CAUUT, CAUUU, CCAETA, CCAETJ, CCAETB, CCAETC, CCAETD, CCAETE, CCAETF, CCAETG, CCAETH, CCAETI, CCAEYA, CCAEYJ, CCAEYB, CCAEYC, CCAEYD,CCAEYE, CCAEYF, CCAEYG, CCAEYH, CCAEYI, CCAFCE,CCAFCN, CCAFCF, CCAFCG, CCAFCH, CCAFCI, CCAFCK, CCAFCL, CCAFCM, CCAFHG, CCAFHH, CCAFHI, CCAFHJ, CCAFHK, CCAFHL, CCAFHM, CCAFJV, CCAFJW, CCAFJX, CCAFJY, CCAFJZ, CCAFNK, CCAFNU, CCAFNL, CCAFNM, CCAFNN, CCAFNO, CCAFNP, CCAFNR, CCAFNS, CCAFNT, CCAFRU, CCAFRV, CCAFRW, CCAFRX, CCAFRY, CCAFRZ, CCAFUP, CCAFUR, CCAFUS, CCAFUT, CCAFUU, CCAFUZ, CCAFUW, CCAFUX, CCAFUY, CCAFZC, CCAFZL, CCAFZD, CCAFZE, CCAFZF, CCAFZG, CCAFZH, CCAFZI, CCAFZK, CCAGDA, CCAGDB, CCAGDC, CCAGDD, CCAGDJ, CCAGDE, CCAGDF, CCAGDG, CCAGDH, CCAGDI REASON: Cable crimp sleeves not heat treated which can cause fracture during crimping MANUFACTURER/RECALLING FIRM: HOWMEDICA OSTEONICS CORP. RUTHERFORD, NJ RECALLED BY: Manufacturer, by letters dated June 18, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Australia, Sweden, Germany, Canada, Chile, China, Holland, France, Spain, Italy, Japan, New Zealand, and United Kingdom. QUANTITY: 8914 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1105-1/Z-1107-1 Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures Codes: a) Model 4380213 - E.CAM Gantry Single Head, serial numbers 0001 thru 2016 b) Model 4380221 - E.CAM Gantry Dual Head, serial numbers 0005 thru 2038, and 31827 Model 5242826 - E.CAM Gantry Dual Head, serial numbers 1001 thru 2012 REASON: Resistor Packs installed backwards cause software errors MANUFACTURER/RECALLING FIRM: SIEMENS MEDICAL SYSTEMS, INC. HOFFMAN ESTATES, IL RECALLED BY: No end user notifications were issued. Siemens initiated a Mandatory Next Service Call Field Modification Instruction (FMI-00270) on 12/4/98 FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and International QUANTITY: 229 units ________________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1109-1 - Z-1110-1, MAC Two Lumen Central Venous Access Kit/Set. Codes:catalog #AK-11142 - Lots: RF1020751, RF1031739, RF1031850, RF1033089, RF1043328, and RF1044374. catalog #SI-11142 - Lots: RF0126277, RF1031741, and RF1043329. REASON: Potential for leakage of fluid or air from hemostasis valve w/obturator in place MANUFACTURER/RECALLING FIRM: ARROW INTL., INC. READING, PA RECALLED BY: The recalling firm sent a recall letter to their accounts dated 7/23/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Germany, Auckland, England, Athens, South Africa, Japan, England, Caracas. QUANTITY: 4710 kits _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1111-1 "Reli On" Insulin Syringe, 3/10 cc, 30 gauge 5/16" (8mm) Needle (sterile).Labeled: "ULTRA COMFORT SHORT NEEDLE Insulin Syringes Reli On U-100 Insulin for 30 Units or Less***3/10cc***". Packed in boxes of 100 Single Use Syringes CODES: Lot number: 374317 Exp. Date: 4/06 REASON: Insulin Syringes Mislabeled as 3/10cc, 30 unit instead of 1/2cc, 50 unit MANUFACTURER: KENDALL/DIV. OF TYCO HEALTHCARE GROUP LP NORFOLK, NE RECALLED BY: KENDALL/ A DIVISION OF TYCO HEALTHCARE MANSFIELD, MA, by telephone on 7/18/01. FIRM INITIATED RECALL: Kendall notified WalMart, Bentonville, AR, by telephone on 7/18/01. WalMart notified their pharmacies by letter on 7/18/01. DISTRIBUTION: Nationwide. QUANTITY: 400,200 syringes _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1112-1 Olympus Uteromat Fluid Control model A4058. Designed for infusion of low viscosity distension media during hysteroscopic procedures to distend the cavum uteri (uterine cavity). Device provides constant monitoring and display of inflow fluid volume and fluid loss, permanent measuring of fluid consumption automatic calculation of the total amount of fluid loss, additional warning for rapid absorption. Codes: Serial Numbers: 0006CM268 - 0006CM272, 0011CM286 – 0011CM295, 0101CM027 – 0101CM031, 0101CM476 – 0101CM480, 9606CE087 – 9606CE104, 9607CE336 – 9607CE345, 9701CE081 – 9701CE084, 9703CE061 – 9703CE070, 9709CE416 – 9709CE425, 9903CM294 – 9903CM303, 9904CM400 – 9904CM409, 9909CM059 – 9909CM064, 9909CM156 – 9909CM169. There are an additional 11 units with serial numbers that do not exist in the Olympus' old computer system (not available in BPCS). REASON: Software malfunction. MANUFACTURER: World of Medicine Gmbh Ludwigsstadt RECALLED BY: Olympus America, Inc. (OAI) Melville, NY, by letters, dated 4/30/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, and Brazil. QUANTITY: 88 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1113-1 - Z-1114-1 Human Heart Valves, processed and frozen, for transplantation Codes: Aortic valves, ID #98-0266HV-01 and ID #98-0271HV-01; Pulmonary Valve, ID #98-0266HV-02 REASON: Sera from donor of human tissues were tested with unapproved method. MANUFACTURER/RECALLING FIRM: LIFENET VIRGINIA BEACH, VA RECALLED BY: Recalling firm, by telephone on 2/12/01 and 3/28/01, and by letter on 3/30/01 and 4/9/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA and NC QUANTITY: 3 valves RECALLS AND FIELD CORRECTIONS: DEVICES-- CLASS III _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0861-1 lMx Glycated Hemoglobin Calibrators; list 1A86-01; an In Vitro diagnostic for calibration of the IMx Analyzer when used for the determination of Glycated Hemoglobin in human anticoagulated whole blood; each kit consists of 6 vials, Calibrators A - F, 0 -2.4 GHb; CODES: List 1A86-01, Lots 68577M200 and 68577M201 REASON: Elevated Low Control values MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park, IL RECALLED BY: Manufacturer, by letters dated 2/28/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and International QUANTITY: 1925 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0863-01 Steri-Oss HL Threaded Implant, HA-Coated 4.5D x 10mm, Endosseous Implant, CODES: Part Number 4610HL; Lot Number 321814 REASON: Label on cap does not match labels on inner and outer vials. MANUFACTURER/RECALLING FIRM: Nobel BioCare USA, Inc. Yorba Linda, CA RECALLED BY: Manufacturer, by letter on June 29, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Germany, Chile, Argentina, Korea, Hong Kong, Japan. QUANTITY: 237END OF ENFORCEMENT REPORT FOR SEPTEMBER 12, 2001. ####
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