NRAC Issue #1463 January 21, 2004 NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C. --------------------------------------------------------------------------- PRODUCT Vitros Immunodiagnostic Products CK-MB Reagent Pack, Ref 189 6836, 100 coated wells per pack. RECALL NUMBER # Z-0298-04. CODE Lot 611, Exp. 25 June 2004. MANUFACTURED & RECALLED BY Ortho-Clinical Diagnostics, Rochester, NY QUANTITY 774 reagent packs. DISTRIBUTION Nationwide and Canada. REASON Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results. --------------------------------------------------------------------------- PRODUCT IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (100 tests - reagents alone). RECALL NUMBER # Z-0293-04. CODE All lots. MANUFACTURED & RECALLED BY Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL QUANTITY 3,475 packs. DISTRIBUTION Internationally. REASON Chemotherapeutic concentrations of methotrexate in patient samples may carryover to subsequent samples, which would result in falsely elevated folate values, when performing IMx Folate testing. --------------------------------------------------------------------------- PRODUCT Bucky Diagnost FS Part number 9890-010-83651. RECALL NUMBER # Z-0268-04. CODE Site numbers: 504495, 105355, 104447. The firm uses site numbers instead of serial numbers. MANUFACTUURED & RECALLED BY Philips Medical Systems Sales & Service Region No American, Bothell, WA. QUANTITY 3 devices. DISTRIBUTION FL, NY, and CA. REASON Support chain attachment on the Bucky carriage may fail and cause the counter weights or X-ray tube to fall. --------------------------------------------------------------------------- PRODUCT Stryker brand Model 1550 Synergy Extended Stay Stretcher. RECALL NUMBER # Z-0267-04. CODE All stretchers manufactured between 1/1/1993 and 11/07/2003. MANUFACTURED & RECALLED BY Stryker Medical, Kalamazoo, MI QUANTITY 3,903. DISTRIBUTION Nationwide, Canada, Hong Kong, Israel, Mexico and Syria. REASON The user may be pinched by the side rail when raising or lowering the side rail. --------------------------------------------------------------------------- PRODUCT Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ. RECALL NUMBER # Z-0266-04. CODE Lot numbers 548727, 548723, 544906, 542967, 542966. MANUFACTURED & RECALLED BY Cardinal Health, McGaw Park, IL QUANTITY 1,083 packs. DISTRIBUTION GA, and AL. REASON The Namic Angiography Kit attached to the outside top of the Custom Sterile Pack is not sterile. --------------------------------------------------------------------------- PRODUCT CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes. RECALL NUMBER # Z- 0264-04. CODE Lot numbers: 207089, 209102, 02121321, 02171838, 02192048, 02212272, 02222332, 02242552, 02262741, 02272856, 02293066, 02313269, 02323381, 02333458, 02363752, 02383927, 02404141, 02414225, 02424507, 02434421, 02434520, 02444529, 02454627, 02454672, 02464725, 02474823, 02484921, 02505121, 03020326, 03040522, 03040669, 03060728, 03060803, 03060865, 03080924, 03101124, 03111222, 03131428, 03151624, 03171820, 03171998, 03192023, 03212226, 03212370, 03232422, 03242537, 03252628, 03262726, 03303276, and 03303313. MANUFACTURED & RECALLED BY Bausch & Lomb, Inc., Rochester, NY QUANTITY 2,500 six packs. DISTRIBUTION Nationwide and Internationally. REASON The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction. --------------------------------------------------------------------------- PRODUCT a) The Architect i2000, Clinical Chemistry Analyzer. RECALL NUMBER # Z-0262-04; PRODUCT b) The Architect c8000, Clinical Chemistry Analyzer, RECALL NUMBER # Z-0263-04. CODE a) List number 3M74-01, all serial numbers; b) List Number 1G06-01, all serial numbers. MANUFACTURED & RECALLED BY Abbott Laboratories, Inc., Irving, TX QUANTITY 371. DISTRIBUTION TX, PA, SC, CA, IN, and Internationally. REASON Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234). --------------------------------------------------------------------------- PRODUCT a) Irrigation aspiration system with double spike tubing and 33 cm probe, latex free, catalog # 55060. Sterile, single use. Hydro-Pro brand and Quanta Technologies L.L.C. brand. RECALL NUMBER # Z-0258-04; PRODUCT b) Irrigation aspiration system for Nexhat Dorsey type pumps with 33 cm probe and tubing, latex free, catalog # 55050. Hydro-Pro brand. RECALL NUMBER # Z-0259-04; PRODUCT c) Reorder # Lapkit 3. Contents: 1- 55060 suction/irrigation valve 2- 30012 insufflations tubing set 3- 5010 anti fog solution with sponge. Sterile. single use. Quanta Technologies L.L.C. brand. RECALL NUMBER # Z-0260-04; PRODUCT d) Auto Suture Irrivac Max Suction irrigation system with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United States Surgical brand. RECALL NUMBER # Z-0261-04. CODE a) Lot 50904994; b) Lot 50904971; c) Lot 994986; d) Lots 50904937 and 50904995. MANUFACTURED & RECALLED BY Vital Concepts, Inc., Grand Rapids, MI QUANTITY 3,273 DISTRIBUTION AZ, IL, IN, MI, and PA. REASON The probe may separate from the cannula. --------------------------------------------------------------------------- PRODUCT Prolene* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3"x6", each mesh in a sealed pouch package, 6 packages per papercard carton. ***STERILE: Sterility of contents guaranteed unless package has been opened or damaged*** RECALL NUMBER # Z-0251-04. CODE Lots RBE609 Exp 1/07, RJJ130 Exp 7/07. MANUFACTURED & RECALLED BY Owens & Minor Distribution, Inc., Glen Allen, VA QUANTITY 423 cartons (6 meshes/carton). DISTRIBUTION Nationwide. REASON Counterfeit product is an unapproved medical device with associated potential health hazard. --------------------------------------------------------------------------- PRODUCT Solar 9500 Information Monitor. RECALL NUMBER # Z-0250-04. CODE Software version 3A. MANUFACTURED & RECALLED BY General Electric Medical Systems Information Technology, Milwaukee, WI QUANTITY Maximum 648 Solar 9500s with Version 3A software (297 Solar 9500 Version. 3A software were manufactured plus 131 software update kits to update multiple). DISTRIBUTION Nationwide. REASON Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first. --------------------------------------------------------------------------- PRODUCT Prolene* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3"x 6", each mesh in a sealed pouch package, 6 packages per papercard carton. RECALL NUMBER # Z-0249-04. CODE All codes, including the lots that the manufacturer of authentic product specified as counterfeit, RBE609 Exp 1/07 and RJJ130 Exp 7/07. MANUFACTURED & RECALLED BY McKesson General Medical Corporation, Richmond, VA QUANTITY 180 cartons (6 each/carton). DISTRIBUTION Nationwide. REASON Counterfeit product is an unapproved medical device with associated potential health hazard. --------------------------------------------------------------------------- PRODUCT Surgical device packaged in a box which is labeled as Sterile with the following identification: "PMII Prolene Mesh Polypropylene Nonabsorbable Synthetic surgical Mesh Ethicon" Additional information including comparisons between authentic Ethicon product and counterfeit are available at the following website: > <>. RECALL NUMBER # Z-0246-04. CODE The firm found in their inventory codes listed in the Ethicon notice of lot numbers RBE609 (expiration date 1/07) and RJJ130 (expiration date 7/07). MANUFACTURED & RECALLED BY Q-Med Corporation, Ft Lauderdale, FL QUANTITY 1,250 boxes of six. DISTRIBUTION VA, and IL. REASON This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark. --------------------------------------------------------------------------- PRODUCT Prolene Polyproplyene Mesh, 3" x 6", Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; RECALL NUMBER # Z-0243-04. CODE Catalog number PMII, lot numbers RBE609, expiration date 1/07, and RJJ130, expiration date 7/07 Note: any box with an orange dot on the end of the box is suspected counterfeit product, regardless of lot number. MANUFACTURED & RECALLED BY Cardinal Health, McGaw Park, IL QUANTITY 365 boxes. DISTRIBUTION Nationwide. REASON Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII. --------------------------------------------------------------------------- PRODUCT VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood. RECALL NUMBER # Z-0242-04. CODE Lot 58151473. MANUFACTURED & RECALLED BY Edwards Lifesciences AG, Haina, San Cristobal, Dominican Republic QUANTITY 21,150. DISTRIBUTION Nationwide. REASON Seal integrity, sterility not assured. --------------------------------------------------------------------------- PRODUCT Phototherapy Lamp, Model 9001W501JE. RECALL NUMBER # Z-0241-04. CODE The potentially affected lamps have serial numbers within the following ranges: 2000 SN 00501XXxxxxx SN 501XXxxxxx SN 2000-501XXxxxxx 2001 SN 2001-501XXxxxxx SN 01-xx xx xxxxxx 2002 SN 02 xx xx xxxxxx 2003 SN 03 xx xx xxxxxx. MANUFACTURED & RECALLED BY Fisher & Paykel Healthcare, Inc., Laguna Hills, CA QUANTITY 88 DISTRIBUTION Nationwide. REASON Component placement presents risk of electrocution to patients. --------------------------------------------------------------------------- PRODUCT Aeroset/Architect c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30. RECALL NUMBER # Z-0240-04. CODE All lots. MANUFACTURED & RECALLED BY Abbott Laboratories Diagnostic Div, South Pasadena, CA QUANTITY Information not available. 192 domestic consignees. DISTRIBUTION Nationwide and Internationally. REASON False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN. --------------------------------------------------------------------------- PRODUCT Misys Laboratory System. RECALL NUMBER # Z-0238-04. CODE Version 5.3 build 63 thru 6.3.2 and Lab Access Results. MANUFACTURED & RECALLED BY Misys Healthcare System, Tucson, AZ QUANTITY 125. DISTRIBUTION Nationwide, Canada, Saudi Arabia, United Kingdom. REASON Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients. --------------------------------------------------------------------------- PRODUCT a) 3M Attest 1264 Biological Indicators, in boxes of 100 per box. RECALL NUMBER # Z-0236-04; PRODUCT b) 3M Attest 1264P Biological Indicators, in boxes of 25 per box. RECALL NUMBER # Z-0237-04. CODE a) Lot numbers 2005-07 DR, 2005-07 DS, 2005-07 DT, 2005-07 DU, 2005-08 DA, 2005-08 DB, 2005-08 DC, 2005-08 DN, and 2005-08 DO; b) Lot numbers 2005-07 DW, 2005-08 DD, and 2005-08 DL. MANUFACTURED & RECALLED BY 3m Health Care, Saint Paul, MN QUANTITY 11,436 boxes (25 to 100 biologic indicators per box). DISTRIBUTION Nationwide and Internationally. REASON The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to negative after 24 hours of incubation. --------------------------------------------------------------------------- PRODUCT Calculator/Data Processing Module for Clinical Use. RECALL NUMBER # Z-0235-04. CODE Versions 5.2, 5.23 and 5.3. MANUFACTURED & RECALLED BY Misys Healthcare Systems, Tucson, AZ QUANTITY 485. DISTRIBUTION Nationwide and Internationally. REASON Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks. --------------------------------------------------------------------------- PRODUCT IMx Tacrolimus II Assay, list 3C10-20. RECALL NUMBER # Z-0230-04. CODE All lot numbers. RECALLED BY Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL QUANTITY Unspecified. DISTRIBUTION Nationwide, and Internationally. REASON Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances. --------------------------------------------------------------------------- PRODUCT ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide. RECALL NUMBER # Z-0229-04. CODE All lots of the German translated patient bracelets. MANUFACTURED & RECALLED BY Alcon Laboratories, Inc., Fort Worth, TX QUANTITY 3,142. DISTRIBUTION Germany, Switzerland, and Austria. REASON The patient bracelet that is given to patients post surgery after administering either ISPAN Perfluoropropane or ISPAN Sulfur Hexafluordie referred to the term, "stickoxid", which is the general term for nitrogen oxide and may be interpreted as either nitrogen monoxide (NO) or dinitrogen monxoide. The firm is recalling the old (blue) bracelets and replacing them with new (gray) bracelets that now reference the specific term dinitrogen monoxide N20 (laughing gas). --------------------------------------------------------------------------- PRODUCT Lithium Carbonate Extended Release Tablets, USP, 300 mg, 100 count bottle, Rx only. RECALL NUMBER # D-102-4. CODE Lot Number/Expiration Date: 403452044T (SEP 2004). MANUFACTURED & RECALLED BY Barr Laboratories, Inc., Forest, VA QUANTITY 3,165 bottles. DISTRIBUTION Nationwide. REASON Dissolution Failure: 12 month stability. --------------------------------------------------------------------------- PRODUCT Buspar Tablets (buspirone HCl, USP), 15 mg, 60 Dividose tablet and 180 Dividose tablet bottles, Rx Only. RECALL NUMBER # D-088-4. CODE Lot No. 3G74918 Expiration Date: Aug 31, 2006 (60 count bottle) Lot No. 3D68441 Expiration Date: Feb 28, 2005 and 3B63278 Expiration Date: Apr 30, 2006 (180 count bottle). MANUFACTURED & RECALLED BY Bristol Myers Squibb Co., C.P.O., Mount Vernon, IN QUANTITY 39,755 bottles. DISTRIBUTION Nationwide. REASON Mislabeled: Dosing instructions for the 15 mg Dividose tablet is incorrect in that the diagram for two-thirds of a tablet should denote a 10 mg dose rather than a 15 mg dose. --------------------------------------------------------------------------- PRODUCT Amiodarone HCL Injection, 150 mg/3ml, 50 mg/ml, 10 x 3 mL Single use Vial, Preservative Free, Rx only, For IV Use Only. RECALL NUMBER # D-087-4. CODE Lot Numbers (Exp Dates): 446102 (06/04), 446103 (06/04), 446104 (07/04), 446105 (06/04), 446106 (10/04), 446107 (10/04), 446110 (10/04), 450470 (10/04), 495013 (11/04), 496062 (11/04), 496799 (11/04), 500104 (11/04), 502519 (02/05), 502522 (02/05), 508688 (06/05). MANUFACTURED & RECALLED BY Bedford Laboratories, Bedford, OH QUANTITY 1,084,800 vials. DISTRIBUTION Nationwide. REASON The vials contain crystalline particulate matter adhering to the bottom of the glass vials. --------------------------------------------------------------------------- PRODUCT Nardil Tablets (Phenelzine Sulfate Tablets, USP), 15 mg, 100 count bottles, Rx Only. RECALL NUMBER # D-082-4. CODE Lot number (Exp. Date): 90113L (11/03), 91913L (11/03), 92513L (12/03), 92613L (12/03), 24113L (12/03), and 24213L (1/04). MANUFACTURED & RECALLED BY Pfizer Inc., New York, NY QUANTITY 95,933 bottles. DISTRIBUTION Nationwide, Canada, Spain, and South Africa. REASON Subpotent: (stability). --------------------------------------------------------------------------- PRODUCT a) Antacid (Calcium carbonate, USP 500 mg), 150 count bottles, Bartell Drugs Mint Flavor Antacid Regular Strength Antacid/Calcium Supplement Sodium Free/Calcium Rich, The product is also labeled as Bartell Drugs Mint Flavor Antacid Regular Strength Antacid/Calcium Supplement Calcium Rich. RECALL NUMBER # D-085-4; PRODUCT b) Antacid Tablets (Calcium Carbonate USP, 750 mg) 96 count bottles, Bartell Drugs Tropical Fruit Flavors Antacid Extra Strength Antacid/Calcium Supplement Great Taste/Calcium Rich. RECALL NUMBER # D-086-4. CODE a) Lot No.(Expiration Date): 311476 (1/04), 309854 (11/03), 310566 (3/03), 318093 (1/04), 317253 (1/04); b) Lot No./Expiration Date: 318125 (1/05), 319441(1/05), 321186(1/05), 322664 (3/05). MANUFACTURED & RECALLED BY Magno Humphries Inc., Tigard, OR QUANTITY 5,952 bottles. DISTRIBUTION Nationwide. REASON a) Misbranding: bottle is incorrectly labeled as containing 200 mg of calcium per serving rather than 400 mg and the percent daily value is incorrectly denoted as 20% rather than 40%; b) Misbranding: bottle is incorrectly labeled as containing 20% daily value of calcium rather than correctly containing 30% daily value of calcium. --------------------------------------------------------------------------- PRODUCT Butalbital, Aspirin, and Caffeine Capsules, (50 mg Butalbital, 325 mg Aspirin, 40 mg Caffeine), 100 count bottles, Rx only. RECALL NUMBER # D-078-4. CODE Lot number M031552024. MANUFACTURED & RECALLED BY Lannett Co, Inc., Philadelphia, PA QUANTITY 4,772 bottles. DISTRIBUTION Nationwide. REASON ANDA/NDA Discrepancies: Manufacturing process used an unapproved source of butalbital. --------------------------------------------------------------------------- PRODUCT Fluoxetine Capsules USP, 10mg, 100 count bottles (Aqua Blue/White), Rx Only. RECALL NUMBER # D-077-4. CODE Lot Number(Exp. Date): 106805 (04/04). MANUFACTURED & RECALLED BY IVAX Pharmaceuticals, Inc., Northvale, NJ QUANTITY 11,204 bottles. DISTRIBUTION Nationwide. REASON Impurities; Total Impurity level exceeded (12 month). --------------------------------------------------------------------------- PRODUCT Paraplatin (carboplatin aqueous solution) Injection, 50 mg per vial, 10 mg per mL sterile, 5 mL vials, For IV Use, Single-Dose Vial, Rx Only, NDC 0015-3210-30. RECALL NUMBER #D-101-4. CODE Lot Number(Expiration Date): 3H63625 (1/31/05). MANUFACTURED & RECALLED BY Bristol-Myers Squibb Co., New Brunswick, NJ QUANTITY 28,027 units. DISTRIBUTION Nationwide. REASON Subpotent: (3 month stability). --------------------------------------------------------------------------- PRODUCT Unasyn for Injection (ampicillin sodium/sulbactam sodium) 1.5 g equivalent to 1 g ampicillin/0.5g sulbactam, 10 Single Dose ADD-Vantage Vial, For Intravenous use only, Rx Only. RECALL NUMBER # D-079-4. CODE Lot Number/Exp. date: R283A (1 Oct 06). MANUFACTURED & RECALLED BY Pfizer Laboratories, Div Pfizer, Inc., Terre Haute,IN QUANTITY 6,629 trays of 10. DISTRIBUTION Nationwide. REASON Lack of Assurance of Sterility. --------------------------------------------------------------------------- PRODUCT APAP tablets, (Acetaminophen), 325 mg, 100 count bottles, DixonÕs (Brand Name). RECALL NUMBER # D-103-4. CODE Lot No. 319687 Exp. 03/05 (bottom of bottle). MANUFACTURED & RECALLED BY Magno Humphries, Inc., Tigard, OR QUANTITY 504 bottles. DISTRIBUTION Nationwide. REASON Mislabeling- bottles labeled to contain 325 tablets actually contain 500 mg acetaminophen caplets. --------------------------------------------------------------------------- PRODUCT a) EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. EndoReturn arterial cannula, 21 Fr. Product code ER21 (07043). The cannulas are also packaged in kits that have no specific lot number. The EndoReturn arterial cannula is packaged in the EndoCPB (Cardiopulmonary Bypass) System with Cardioplegia Catheter, Product codes ECPB211, 212, 213, 214, 231, 232. Also, the EndoCPB system without Cardioplegia Catheter, Product codes ECPB211, 212, 231, 232. RECALL NUMBER # Z-0307-04; PRODUCT b) EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. EndoReturn arterial cannula, 23 Fr. Product code ER23 (07044). RECALL NUMBER # Z-0308-04; PRODUCT c) DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. DirectFlow arterial cannula, 24Fr, Product Code DFK24 (06723). The cannulas are also packaged in kits that have no specific lot numbers associated. The kits are identified as the ENDODIRECT System, Product codes ED241, 242, 243, 244. RECALL NUMBER # Z-0309-04; PRODUCT d) SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoClamp-ST II aortic catheter. SoftClamp II arterial cannula, 24Fr. SCK (06724). Cannulas are also packaged in kits with no specific lot numbers associated. The kits is identified as SoftClamp System, Product Code SC-24. RECALL NUMBER # Z-0310-04; PRODUCT e) Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042). RECALL NUMBER # Z-0311-04. CODE a) Lot Numbers 020349, 050327, 060337; b) Lot Numbers 020347, 030343, 060338, 080348; c) Lot Numbers 010367, 020342, 020378, 020379, 020380, 030353, 060358; d) Lot numbers 030356, 050347, 060359; e) Lot number 020374. MANUFACTURED & RECALLED BY Heartport Inc, Somerville, NJ QUANTITY 933. DISTRIBUTION Nationwide and Internationally. REASON Damaged hemostasis valves that prevent or present difficulty when inserting catheters. --------------------------------------------------------------------------- PRODUCT a) Arrow A Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable Vascular Access System (Product # AP-06520) Product # AP-06520 kit contains 1 implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), straight non-coring needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case). RECALL NUMBER # Z-0254-04; PRODUCT b) Arrow A Port with Attachable Silicone Rubber Catheters Implantable Vascular Access System (Product # AP-01510). Product # AP-01510 kit contains 1 implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm) straight non-coring needle, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case). RECALL NUMBER # Z-0255-04; PRODUCT c) Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable (Product # AP-06042) [NB: titanium port]. Product # AP-06042 kit contains 1 low profile implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), injection needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case). RECALL NUMBER # Z-0256-04; PRODUCT d) Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable Vascular Access System (Product # AP-06022) [NB: plastic port] Product # AP-06022 kit contains 1 low profile implantable plastic port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), straight non-coring needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case). RECALL NUMBER # Z-0257-04. CODE a) AP-06520 MF3074927 MF3075118 MF3085217 MF3085281 MF3095491 MF3095574 MF3095611; b) AP-01510 MF3085292 MF3085315 MF3095551 MF3095651; c) AP-06042 MF3075086 MF3075140 MF3085285; d) AP-06022 MF3075080 MF3085227 MF3085410. MANUFACTURED & RECALLED BY Arrow International, Inc., Mount Holly, NJ QUANTITY 913. DISTRIBUTION Nationwide and Internationally. REASON The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided. --------------------------------------------------------------------------- PRODUCT Sure Temp Plus Model 690/692 Oral Temperature Probes. RECALL NUMBER # Z-0354-04. CODE Welch Allyn¨ Part #s: 0690-XXX Serial Numbers/Lot Numbers 02692-000 Oral Probe 4 ft. 412003-442003, 472003, 522003-582003. 02692-100 Oral Probe 9 ft. 412003-442003, 472003, 522003-582003 02893-000 Oral Probe Well Kit 4 ft. 412003-442003, 472003, 522003-582003 02893-100 Oral Probe Well Kit 9 ft. 412003-442003, 472003, 522003-582003 Probes are contained in Welch Allyn¨ Thermometer Boxes with Part #s: 0690-XXX Serial Numbers/Lot Numbers 01690-000 03397655 - 03505486 01690-200 03397655 - 03505486 E-01690-200 03397655 - 03505486 01690-300 03397655 - 03505486 01690-400 03397655 - 03505486 01690-410 03397655 - 03505486 01690-500 03397655 - 03505486 E-01692-200 03397655 - 03505486 01692-200 03397655 - 03505486 01692-300 03397655 - 03505486 01692-400 03397655 - 03505486 01692-500 03397655 - 03505486 01692-700 03397655 - 03505486 Probes are contained in Welch Allyn¨ Vital Signs Monitor III boxes with Part Numbers: Serial Numbers/Lot Numbers 53NTO-E1 JA000244, JA000282, JA000283, JA000284, JA000285, JA000286, JA000287, JA000288, JA000289, JA000290, JA000291, JA000292, JA000293, JA000294, JA000295, JA000296, JA000297, JA000298, JA000299, JA000300, JA000301, JA000302, JA000303, JA000304, JA000305, JA000306, JA000307, JA000308, JA000309, JA000310, JA000311, JA000312, JA000313, JA000314, JA000315, JA000316, JA000317, JA000318, JA000319, JA000320, JA000331, JA000332, JA000333, JA000334, JA000335, JA000336, JA000337, JA000340, JA000341, JA000342, JA000343, JA000344, JA000345, JA000347, JA000348, JA000349, JA000352, JA000353, JA000354 53NTP-E1 JA000232, JA000243, JA000246, JA000255, JA000258, JA000259, JA000271, JA000278, JA000281, JA000326, JA000327, JA000328, JA000357. MANUFACTURED & RECALLED BY Welch Allyn, Inc., San Diego, CA QUANTITY 4,453. DISTRIBUTION Nationwide. REASON Mechanical setting errors that result in calibration errors. --------------------------------------------------------------------------- PRODUCT a) Hollow Fiber Dialyzer Model Filtryzer B1-1.3H. RECALL NUMBER #Z-0349-04; PRODUCT b) Hollow Fiber Dialyzer Model Filtryzer B3-1.0A, B3 -1.3A, and B3-1.6a. RECALL NUMBER # Z-0350-04; PRODUCT c) Hollow Fiber Dialyzer, Model Filtryzer BK-2.IU. RECALL NUMBER # Z-0351-04; PRODUCT d) Hollow Fiber Dialyzer, Model Toraysulfone BS-1.6, and BS-1.8. RECALL NUMBER #Z-0352-04. CODE a) Lot 10830640 (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual units or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.); b) Lot numbers: 10630840, 10230940, and 20230540. (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual units or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.); c) Lot numbers 10531140, 11230940, 20121440, and 21230140. (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual units or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.); d) Lot numbers: 20310140, 20910540, and 20910541. (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual unit or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.). MANUFACTURED & RECALLED BY Toray Marketing & Sales (America),Inc. Houston, TX QUANTITY 768 units. DISTRIBUTION CA, NJ, FL, TX, OH, WI, NY, and WA. REASON Potential loose header (end cap) on hollow fiber dialyzers. --------------------------------------------------------------------------- PRODUCT a) Smith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates unit previously serviced). RECALL NUMBER # Z-0247-04; PRODUCT b) Smith & Nephew Endocoupler C-Mount 35 mm Focal Length Reference :7204614 and 7204614S (S indicates unit previously serviced). RECALL NUMBER # Z-0248-04. CODE a) Part Number: 7204823, Camera Coupler, C-Mount, 30mm F.L. Serial Numbers (SR prefix): 8632 8646 8652 8659 8670 8679 8693 8709 8714 8633 8647 8655 8660 8675 8686 8694 8711 8716 8635 8648 8657 8665 8676 8687 8712 8727 8636 8649 8658 8668 8677 8691 8707 8713 8728 Part Number: 7204823S, Camera Coupler, C-Mount, 30mm F.L. Serial Number SR8705; b) Number: 7204614, Camera Coupler, C-Mount, 35mm F.L. Serial Numbers (QW prefix): 15601 16920 16981 18031 18066 18111 18143 18276 18354 15603 16924 16982 18032 18067 18112 18147 18278 18355 15604 16927 16983 18033 18068 18113 18149 18282 18358 15605 16932 16985 18035 18069 18114 18157 18283 18359 15607 16933 16987 18036 18070 18116 18158 18284 18362 15606 16935 16988 18039 18071 18118 18168 18288 18363 15609 16936 16989 18040 18072 18119 18169 18289 18370 15612 16950 16990 18041 18073 18120 18177 18291 18382 15617 16951 16991 18042 18074 18121 18187 18292 18391 15622 16957 16992 18043 18075 18122 18188 18295 18399 15623 16958 16993 18044 18076 18123 18189 18296 18445 15626 16961 16994 18045 18077 18125 18198 18300 18460 15630 16962 17005 18046 18078 18126 18199 18301 18461 16697 16964 17006 18047 18079 18127 18200 18303 18462 16713 16965 17025 18048 18080 18128 18201 18304 18464 16719 16966 17029 18049 18084 18129 18203 18306 18469 16720 16967 17030 18050 18088 18130 18204 18307 18470 16722 16968 17045 18051 18093 18131 18205 18308 18471 16726 16969 17050 18052 18097 18132 18206 18309 18476 16729 16970 17052 18053 18098 18133 18207 18310 18477 16797 16971 17068 18054 18100 18134 18209 18315 18478 16891 16972 17069 18055 18101 18135 18210 18325 18479 16897 16973 17092 18056 18102 18136 18212 18326 18480 16898 16974 17100 18057 18103 18137 18219 18336 16899 16975 18000 18059 18104 18138 18239 18342 16907 16976 18001 18060 18105 18139 18258 18346 16914 16977 18024 18062 18107 18140 18266 18351 16915 16978 18029 18063 18108 18141 18269 18352 16916 16980 18030 18064 18110 18142 18275 18353 Part Number: 7204614S, Camera Coupler, C-Mount, 35mm F.L. Serial Numbers (QW prefix): 18034 18096 18160 18259 18297 18383 18416 18434 18453 18038 18099 18161 18260 18313 18384 18417 18435 18454 18058 18106 18162 18261 18314 18385 18418 18436 18455 18061 18109 18163 18262 18316 18386 18419 18437 18456 18065 18115 18164 18263 18323 18393 18420 18438 18457 18081 18144 18165 18264 18324 18394 18421 18439 18458 18082 18145 18166 18267 18333 18395 18422 18440 18459 18083 18146 18167 18270 18334 18402 18423 18441 18463 18085 18148 18170 18272 18335 18403 18424 18442 18465 18086 18150 18171 18273 18344 18404 18425 18443 18466 18087 18151 18172 18274 18345 18405 18426 18444 18467 18089 18152 18231 18277 18356 18408 18427 18446 18472 18090 18153 18232 18279 18364 18411 18428 18447 18473 18091 18154 18246 18285 18366 18412 18429 18448 18474 18092 18155 18250 18287 18373 18413 18430 18450 18475 18094 18156 18256 18293 18374 18414 18431 18451 18095 18159 18257 18294 18376 18415 18433 18452. MANUFACTURED & RECALLED BY Smith And Nephew, Inc., Endoscopy Division, Andover, MA QUANTITY 447 units. DISTRIBUTION Nationwide and Internationally. REASON Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process. --------------------------------------------------------------------------- PRODUCT a) Neonate 4 Disposable Blood Pressure Cuff With 1 Tube, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn "Tycos" and Allegiance "Tactics" labels. The "4" represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: Welch Allyn Tycos #5082-104-1 (10 pack/1 tube); Welch Allyn Tycos #5082-241-9 (5 pack/1 tube, multi-size pack); Allegiance Tactics #30502-113S (case of 40/1tube); Welch Allyn Tycos/Allegiance #5082-241-15 (5 pack/1 tube, multi-size pack); RECALL NUMBER # Z-0244-04. PRODUCT b) Neonate 4 Disposable Blood Pressure Cuff With 2 Tubes, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn "Tycos" and Allegiance "Tactics" labels. The "4" represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: Welch Allyn Tycos #5082- 104-2 (10 pack/2 tubes); Welch Allyn Tycos #5082-104-2CL (10 pack/2 tubes, with clamp); Welch Allyn Tycos #5082- 241-10 (5 pack/2 tubes, multi-size pack); Allegiance Tactics #30502-113 (case of 40/2 tubes); Allegiance Tactics #30502-213 (case of 40/2 tubes, with clamp); Welch Allyn Tycos/Allegiance #5082-241-16. RECALL NUMBER # Z-0245-04. CODE a) Code dates between June 20, 2003 and October 8, 2003. (Codes found on the outer carton only.); b) Code dates between June 20, 2003 and October 8, 2003. (Codes found on outer carton only.). MANUFACTURED & RECALLED BY Welch Allyn, Inc., Skaneateles Falls, NY QUANTITY 26,190 units. DISTRIBUTION Nationwide, Singapore, Ireland, Australia, and South Africa. REASON Incorrect location of inflatable portion of cuff that may result in cuff falling off patient's arm, error code when used with patient monitor, or an inaccurate reading. --------------------------------------------------------------------------- PRODUCT a) Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Standard, Product #ATB35. RECALL NUMBER # Z-0212-04; PRODUCT b) Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Vascular/Thin, Product #ATW35. RECALL NUMBER # Z-0213-04; PRODUCT c) FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD065. RECALL NUMBER # Z-0214-04; PRODUCT d) FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD063. RECALL NUMBER # Z-0215-04; PRODUCT e) FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #FBW24. RECALL NUMBER # Z-0216-04; PRODUCT f) FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD064. RECALL NUMBER # Z-0217-04; PRODUCT g) FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KBW16. RECALL NUMBER # Z-0218-04; PRODUCT h) FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KNB21. RECALL NUMBER # Z-0219-04; PRODUCT i) FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL22. RECALL NUMBER # Z-0220-04; PRODUCT j) General Laparoscopic Tray, Product #TGL33. RECALL NUMBER # Z-0221-04; PRODUCT k) General Laparoscopic Tray, Product #TGL53. RECALL NUMBER # Z-0222-04; PRODUCT l) FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL56. RECALL NUMBER # Z-0223-04; PRODUCT m) FlexTray Procedure Delivery System Endopath Gynecololgy Tray, Product #FN065. RECALL NUMBER # Z-0224-04; PRODUCT n) FlexTray Procedure Delivery System Endopath Gastric Tray, Product #KGB11. RECALL NUMBER # Z-0225-04; PRODUCT o) FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL45. RECALL NUMBER # Z-0226-04. CODE a) Lot Numbers: T4VP02, T4VU1R, T4VV8G, T4VY38, T4W14P, T4W31X, T4W40L, T4W49R, T4W78J, T4W94K, T4W94L, T4WD1Z, T4WE79, T4WG29, T4WH7T, T4WP20, T4WP6M, T4WR1U, T4WV5C, T4WV5D, T4WX38, T4WY96, T4WY9P, T4WZ5H, T4X06W, T4X19X, T4X19Y, T4X21T, T4X54V, T4X84D, T4XC4X, T4XC4Y, T4XD42, T4XD46, T4XE9P, T4XF1L, T4XM0T, T4XM0U, T4XN1K, T4XV2R, T4XV2T, T4XW1U, T4XW1V, T4XZ65, T4Y28Z, T4Y465, T4Y466, T4Y77P, T4Y801. b) Lot Numbers: T4VM9R, T4VN0R, T4VNOX, T4VP71, T4VR0U, T4VR3F, T4VR8Z, T4VT68, T4VT75, T4VU1Z, T4VV8U, T4VW33, T4VW34, T4VW7F, T4VW97, T4VX7P, T4VX7R, T4W03T, T4W11A, T4W11X, T4W188, T4W189, T4W31Y, T4W66N, T4W66T, T4W67V, T4W70V, T4W86G, T4W86H, T4W86N, T4WA3R, T4WA6T, T4WA9Z, T4WD68, T4WD6L, T4WD6M, T4WG04, T4WG05, T4WG4K, T4WG6T, T4WG90, T4WH0K, T4WH5J, T4WH5X, T4WH7N, T4WH9G, T4WK6Z, T4WK70, T4WL2U, T4WM6V, T4WN19, T4WN2K, T4WT0F, T4WT0G, T4WU2P, T4WU4L, T4WU5G, T4WU9W, T4WV7E, T4WV8X, T4WX7E, T4WY7P, T4WY7R, T4WZ62, T4X11U, T4X15M, T4X16G, T4X27L, T4X28X, T4X35P, T4X367, T4X46T, T4X46U, T4X631, T4X634, T4X706, T4X707, T4X708, T4X78T, T4X83P, T4X904, T4X905, T4X929, T4XA2Z, T4XA30, T4XC31, T4XE0A, T4XE20, T4XE21, T4XE8Z, T4XE9M, T4XE9N, T4XG9Y, T4XG9Z, T4XH00, T4XH01, T4XK06, T4XK08, T4XK09, T4XM47, T4XM48, T4XM7L, T4XN4Z, T4XN53, T4XN5N, T4XR2N, T4XR2R, T4XT15, T4XU8W, T4XV2K, T4XV2N, T4XW40, T4XW79, T4XZ9L, T4Y01X, T4Y02U, T4Y16K, T4Y16L, T4Y16M, T4Y21N, T4Y21P, T4Y21R, T4Y26W, T4Y26X, T4Y272, T4Y39G, T4Y39L, T4Y634, T4Y635, T4Y636, T4Y75M, T4Y75N, T4Y75P, T4Y75R, T4Y75T, T4YA05, T4YA06, T4YC2K, T4YC2M, T4YC2P; c) Lot Numbers: T4W63C, T4WA2D, T4WD82, T4WT5U, T4Y19Z; d) Lot Numbers: T4W23Y, T4WA33, T4WN15, T4WN5A, T4XY22, T4XZ1E; e) Lot Numbers: T4VZ68, T4W30K, T4W881, T4WL7Z, T4WR5X, T4WT38, T4WY34, T4X38G, T4X52L, T4YC9J; f) Lot Numbers: T4W19H, T4WN1J; g) Lot Numbers: T4XD0F, T4XK71; h) Lot Numbers: T4VT9K, T4Y61F; i) Lot Numbers: T4VU41, T4VY0X, T4W345, T4W346, T4WY38, T4X059, T4X33K, T4YC9Z, T4YE00; j) Lot Numbers: T4WF6D, T4WT8Y, T4X52J, T4Y03E; k) Lot Numbers: T4WP5P; l) Lot Numbers: T4YD0G; m) Lot Numbers: T4VX78, T4WK0G, T4WL8T, T4XH6P, T4Y96L; n) Lot Numbers: T4VN3C, T4W02R, T4W76M, T4WA05, T4WK2N, T4X33J. o) Lot Numbers: T4WX67, T4X22Y, T4X95D, T4XG4C, T4XK7M, T4XM7U, T4XY24, T4Y32W. MANUFACTURED & RECALLED BY Ethicon Endo-Surgery, Cincinnati, OH QUANTITY 67,530 units. DISTRIBUTION Nationwide and Internationally. REASON A defective articulation band may result in improper staple formation with possible hematosis. --------------------------------------------------------------------------- 1