June 13, 2001 1-23RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT: Coconut Dips candy, milk chocolate, sugar-free in 8 oz.clear plastic bags. Recall # F-417-1. CODE: All product on the market at the time the recall was initiated. MANUFACTURER: H.R. Davis Candy Company, Canton, OH. RECALLED BY: Manufacturer, by telephone and letter beginning on March 3, 2001. Firm intiated recall is complete. DISTRIBUTION: OH. QUANTITY: 56-8 oz. bags. REASON: The product contained undeclared sulfites.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
__________ PRODUCT: Serostim® 6 mg [Somatropin (rDNA origin) for injection], Rx. Each box contains 7 vials of Serostim® and 7 vials of sterile water for injection (diluent). Product is used for the treatment of AIDS patients. NDC 44087-0006-7. Recall # D-225-1. CODE: Lot MNK612A (exp. “08/02”) RECALLING FIRM/DISTRIBUTOR: Bellco Drug Corp., Amityville, New York. RESPONSIBLE FIRM AND MANUFACTURER: Unknown. RECALLED BY: The recalling firm (Bellco Drug Corp.) sent an “Urgent: Drug Recall” letter on 2/22/01. DISTRIBUTION: NY. QUANTITY: Unknown. REASON: Counterfeit. ________ PRODUCT: Serostim® 6 mg [Somatropin (rDNA origin) for injection], Rx. Each box contains 7 vials of Serostim® and 7 vials of sterile water for injection (diluent); used for the Treatment of AIDS patients. NDC 44087-0006-7. Recall # D-227-1. CODE: Lot MNK612A (exp. “08/02”). RESPONSIBLE FIRM AND MANUFACTURER: Unknown. RECALLED BY: Quality King Distributors, Inc., Ronkonkoma, New York, by “Urgent Voluntary Drug Recall” letter on 2/02/01. DISTRIBUTION: Nationwide. QUANTITY: Lot MNK612A (exp. 08/02) - 250 boxes. REASON: Counterfeit. ________ PRODUCT: Serostim 6 mg, (somatropin (rDNA origin) for injection, each carton contains seven vials of containing 6mg of somatropin, and seven vials of sterile diluent each containing 1 mL. Recall # D-228-1. CODE: MNK612A EXP 08/02, NDC 44087-0006-7. DISTRIBUTOR: Professional Wholesale, Inc., Baldwin Park, CA. RECALLED BY: Distributor, by letter. RESPONSIBLE FIRM AND MANUFACTURER: Unknown. DISTRIBUTION: AR, CA, KY, and TX. QUANTITY: 507 cartons. REASON: Counterfeit. ________ PRODUCT: Serostim 6 mg, (somatropin (rDNA origin) for injection, each carton contains seven vials of containing 6mg of somatropin, and seven vials of sterile diluent each containing 1 mL. Recall # D-229-1. CODE: MNK612A. Exp "08/02". RESPONSIBLE FIRM AND MANUFACTURER: Unknown. RECALLED BY: Dutchess Business Services, Inc., Las Vegas, NV, by fax on 12/19/00. DISTRIBUTION: KY, NV, NY, and CA. QUANTITY: 807 boxes. REASON: Counterfeit.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT: Defense Blood Standard System, Blood Bank Computer Software, - In use at 79 military facilities. Recall # B-897-1. CODE: Versions 3.00 and 3.01. MANUFACTURER: Electronic Data Systems (EDS), Herndon, VA. RECALLED BY: Department of Defense, Composite Health Care System II, DBSS Project Office, Falls Church, VA., sent a technical bulletins to seventy nine military facilities on July 21, 2000. Firm initiated recall is complete. DISTRIBUTION: Nationwide, Japan, Italy, England, Germany, South Korea, Guam. QUANTITY: 79 units. REASON: Due to a defect in computer software, expired blood products that were returned, and units that were received at out of spec temperatures, were not quarantined. ________ PRODUCT: Red Blood Cells. Recall # B-1137-1; Platelets. Recall #B-1138-1. CODES: Unit number 04LE21384. MANUFACTURER: The American National Red Cross, New England Region, Dedham, MA. RECALLED BY: Manufacturer, by letter dated December 15, 2000. Firm initiated recall is complete. DISTRIBUTION: NY and MA. QUANTITY: 2 units. REASON: Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. ________ PRODUCT: Platelets, Pheresis, Leukoreduced. Recall # B-1146-1. CODE: Unit 15-0101778, 15-0102078, 15-0101768. MANUFACTURER: Blood Systems, Incorporated, Midland, TX. RECALLED BY: Blood Systems, Incorporated, Scottsdale, AZ, by telephone on August 14, 2000, and by letter dated September 15, 2000. Firm initiated recall is complete. DISTRIBUTION: TX. QUANTITY: 2 units. REASON: Platelets, Pheresis products, labeled as Leukocyte Reduced, without white blood cell count determinations, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1198-1; b) Platelets. Recall # B-1199-1; c) Recovered Plasma, Frozen. Recall # B-1200-1. CODE: a), b) and c) Unit 9108715. MANUFACTURER: Medic Regional Blood Center, Knoxville, TN. RECALLED BY: Manufacturer, by letters dated June 24, 1999. Firm initiated recall is complete. DISTRIBUTION: TN and NY. QUANTITY: 3 units. REASON: Blood products, which tested negative for anti-HCV but were collected from a donor who previously tested positive, were distributed. ________ PRODUCT: Platelets. Recall # B-1190-1. CODES: Unit 16LY91297 MANUFACTURER: American Red Cross Blood Services, Central Ohio Region, Columbus, OH. RECALLED BY: Manufacturer, by letter dated January 29, 2001. Firm initiated recall is complete. DISTRIBUTION: OH. QUANTITY: 1 unit. REASON: Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed. _______ PRODUCT: Whole Blood. Recall # B-1285-1. CODE: Units 13L99788, 13L99793. MANUFACTURER: American Red Cross Blood Services, Southeastern Region, Detroit, MI. RECALLED BY: Manufacturer, by telephone on October 2, 2000, and by letter on January 29, 2001. Firm initiated recall is complete. DISTRIBUTION: MI. QUANTITY: 2 units. REASON: Blood products, which were mislabeled as CMV antibody negative, were distributed. _______ PRODUCT: a) Red Blood Cells, Leukocytes Reduced. Recall # B-1319-1; b) Platelets. Recall # B-1320-1. CODE: a) and b) Unit 0331822. MANUFACTURER: Community Blood Center of Greater Kansas, Kansas City, MO. RECALLED BY: Manufacturer, by telephone on April 25, 2000. Firm initiated recall is complete. DISTRIBUTION: MO. QUANTITY: 2 units. REASON: Blood products, collected from a donor who had traveled to an area designated as endemic for malaria, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1321-1; b) Platelets. Recall # B-1322-1. CODE: a) Units T88662, M85537, T96831, K07054, K09564; b) Units K09564. MANUFACTURER: Community Blood Center of Greater Kansas, Topeka, KS. RECALLED BY: Manufacturer, by letters dated September 10, 1998. Firm initiated recall is complete. DISTRIBUTION: MA,MO, KS, AR. QUANTITY: 6 units. REASON: Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1336-1. b) Recovered Plasma. Recall # B-1337-1. CODE: a) and b) Units 55FR06440, 55R16700. MANUFACTURER: American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AR. RECALLED BY: Manufacturer, by letters dated June 20, 2000, and July 19,2000. Firm initiated recall is complete. DISTRIBUTION: AR and CA. QUANTITY: 4 units. REASON: Blood products, collected from a donor who had engaged in high risk behaviors, were distributed. ________ PRODUCT: Red Blood Cells. Recall # B-1340-1. CODE: Unit 28LR07843. MANUFACTURER: American Red Cross Blood Services, Myrtle Beach, SC. RECALLED BY: American Red Cross Blood Services, South Carolina Region, Columbia, SC, by letter on April 15, 1999. Firm initiated recall is complete. DISTRIBUTION: SC. QUANTITY: 1 unit. REASON: Blood product, collected from a donor who had may have traveled to an area designated as endemic for malaria, was distributed. ________ PRODUCT: Red Blood Cells, Deglycerolized. Recall # B-1357-1. CODE: Unit 4118190. MANUFACTURER: LifeSource, Glenview, IL. RECALLED BY: Manufacturer, by telephone on October 26, 2000. Firm initiated recall is complete. DISTRIBUTION: IL. QUANTITY: 1 unit. REASON: Deglycerolized blood product, which was not visually examined for residual glycerol, were distributed. ________ PRODUCT: Deglycerolized Red Blood Cells. Recall # B-1358-1. CODE: Units 2701863, 2701897. MANUFACTURER: Central California Blood Center, Fresno, CA. RECALLED BY: Manufacturer, by telephone on September 21, 1999. Firm initiated recall is complete. DISTRIBUTION: CA. QUANTITY: 1 unit. REASON: Deglycerolized blood products, which were not tested or visually examined for residual glycerol, were distributed. ________ PRODUCT: a) Leukocytes. Recall # B-1359-1; b) Source Plasma. Recall # B-1360-1. CODE: a) Unit 0820584360. b) Units 0820585348, 0820585045, 0820584360, 0820584031, 0820583630, 0820583222, 0820582493, 0820582104, 0820581054, 0820580767, 0820580310, 0820579612, 0820579316, 0820578817, 0820579458, 0820578099, 0820576995, 0820576702, 0820575922, 0820575718, 0820575154, 0820574843, 0820572160, 0820571728, 0820570447, 0820585992, 0820574138, 0820573976, 0820573080, 0820572856, 0820569247, 0820568844, 0820568215, 0820567987, 0820567358, 0820567133, 0820566380, 0820565406, 0820564381, 0820564068, 0820582779, 0820581757, 0820570017, 0820565837, 0820565041. MANUFACTURER: North American Biologicals, Inc., Detroit, MI. RECALLED BY: North American Biologicals, Boca Raton, FL, by "Lookback reports" sent on June 8, 1999 or June 15, 1999, implying that the donor had initially tested positive on May 13, 1999. Corrected recall letters were sent May 10, 2001. Firm- initiated recall complete. DISTRIBUTION: FL, VA, NJ, Austria and Korea. QUANTITY: 46 units. REASON: Blood products, collected from a donor who had been previously deferred or a reactive anti-HCV test, were distributed. ________ PRODUCT: Recovered Plasma. Recall # B-1389-1. CODE: Unit numbers 07K57585, 07K58903, and 07K61771. MANUFACTURER: The American National Red Cross, Arizona Region, Tucson, AZ. RECALLED BY: Manufacturer, by letter dated March 8, 2000. Firm initiated recall is complete. DISTRIBUTION: CA. QUANTITY: 3 units. REASON: Blood products, that tested negative for antibody to human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor that previously tested repeatedly reactive for anti-HIV-1, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1390-1; b) Fresh Frozen Plasma. Recall # B-1391-1. CODE: a) and b) Unit number 07FK34372. MANUFACTURER: The American National Red Cross, Arizona Region, Tucson, AZ. RECALLED BY: Manufacturer, by letter dated February 21, 2000. Frim initiated recall is complete. DISTRIBUTION: CA and AZ. QUANTITY: 2 units. REASON: Blood products, that tested negative for hepatitis, but were collected from an unsuitable donor based on previous reactive hepatitis testing, were distributed. ________ PRODUCT: a) Red Blood Cells, Leukocytes Reduced. Recall # B-1393-1; b) Recovered Plasma. Recall # B-1394-1. CODE: a) and b) Unit number 3619500. MANUFACTURER: Community Blood Bank of Lancaster, County Medical Society, Lincoln, NE. RECALLED BY: Manufacturer, by telephone and facsimile on August 30, 2000, and issued a follow-up letter to the consignee of the Recovered Plasma on December 21, 2000. Firm initiated recall is complete. DISTRIBUTION: NE, FL and Switzerland. QUANTITY: 2 units. REASON: Blood products, that tested initially reactive for hepatitis B surface antigen (HBsAg), were distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1432-1; b) Recovered Plasma. Recall # B-1433-1. CODE: a) Unit numbers 18GG28219 and 18L71590 b) Unit numbers 18GG28219, 18L71590, and 18H33857. MANUFACTURER: The American National Red Cross, Great Lakes Region, Lansing, MI. RECALLED BY: Manufacturer, by letters dated May 30, 2000, and June 9, 2000. Firm initiated recall is complete. DISTRIBUTION: MI and Switzerland. QUANTITY: 5 units. REASON: Blood products, collected from an ineligible donor, were distributed. ________ PRODUCT: Red Blood Cells. Recall # B-1434-1. CODE: Unit number K24880. MANUFACTURER: Community Blood Center of Greater Kansas City, Topeka, KS. RECALLED BY: Manufacturer, by letter dated October 6, 1998. Firm initiated recall is complete. DISTRIBUTION: KS and Switzerland. QUANTITY: 1 unit. REASON: Blood products, collected from a donor that did not answer one of the medical history questions concerning risk of infection with the human immunodeficiency virus (HIV), were distributed. ________ PRODUCT: Source Plasma. Recall # B-1436-1. CODE: Unit numbers 00GMIA6092, 00GMIC5098, and 00GMIC5350. MANUFACTURER: Community Bio-Resources, Inc., Grand Rapids, MI. RECALLED BY: Community Bio-Resources, Inc., Hoover, AL., by letter dated July 5, 2000. Firm initiated recall is complete. DISTRIBUTION: MI and Austria. QUANTITY: 1 unit. REASON: Blood products, collected from an ineligible donor, were distributed. ________ PRODUCT: Red Blood Cells. Recall # B-1437-1; Recovered Plasma. Recall # B-1438-1. CODE: Unit number M85777. MANUFACTURER: Community Blood Center of Greater Kansas City, Topeka, KS. RECALLED BY: Manufacturer, by letter dated October 25, 1998. Firm initiated recall is complete. DISTRIBUTION: MO and FL. QUANTITY: 2 units. REASON: Blood products, collected from an unsuitable donor due to behavior associated with an increased risk of infection with the human immunodeficiency virus (HIV), were distributed. ________ PRODUCT: a) Red Blood Cells, Leukocytes Reduced. Recall # B-1439-1; b) Platelets. Recall # B-1440-1; c) Recovered Plasma. Recall # B-1441-1. CODE: a), b) and c) Unit number 39G09394. MANUFACTURER: American Red Cross Blood Services, Greater Alleghenies Region, Huntington, WV. RECALLED BY: Manufacturer, by letters dated December 7, 2000, December 12, 2000, and January 8, 2001. DISTRIBUTION: WV, OH, NY. QUANTITY: 3 units. REASON: Blood products, collected from an unsuitable donor due to behavior associated with an increased risk of infection with the human immunodeficiency virus (HIV)or the hepatitis B virus (HBV), were distributed.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT: Platelets, Pheresis - Leukocytes Reduced, Irradiated. Recall # B-990-1. CODE: Unit 19236-2697. MANUFACTURER: United Blood Services, Reno, NV. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by telephone and letter on September 14, 1998. Firm initiated recall is complete. DISTRIBUTION: NV. QUANTITY: 1 unit. REASON: Blood product, which was collected from a donor with an elevated body temperature, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-1204-1. b) Red Blood Cells, Leukocytes Reduced. Recall #B-1205-1. CODE: a) Unit 12449-8420; b) Unit 12449-3381. MANUFACTURER: Blood Systems, Inc., McAllen, TX. RECALLED BY: Manufacturer, by telephone on January 10, 2001 and by letter dated January 25, 2001. Firm initiated recall is complete. DISTRIBUTION: TX. QUANTITY: 2 units. REASON: Blood products, which were incorrectly tested for anti-e and labeled as “e negative”, were distributed. _______ PRODUCT: Platelet, Pheresis. Recall #B-1206-1. CODE: Units: 49GP04197, 49GP04199 (split unit), 49GP04200, 49GP04202. MANUFACTURER: American National Red Cross, Southwest Region,Tulsa, Oklahoma. RECALLED BY: Manufacturer, letter dated December 20, 2000. Firm initiated recall complete. DISTRIBUTION: TX and OK. QUANTITY: 5 units. REASON: Blood products, which were exposed to unacceptable shipping temperature, were distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Reduced, Pheresis (2nd Bag). Recall #B-1207-1. CODE: Unit: 17194-1720. MANUFACTURER: Blood Systems, Inc., McAllen, TX. RECALLED BY: Manufacturer, by telephone on February 7, 2001. Firm initiated recall is complete. DISTRIBUTION: TX. QUANTITY: 1 unit. REASON: Blood product, for which a red cell count was not performed, was distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall # B-1208-1. CODES: Unit: 17193-0021. MANUFACTURER: Blood Systems, Inc., San Angelo, TX. RECALLED BY: Manufacturer, by telephone on October 13, 2000. Firm initiated recall is complete. DISTRIBUTION: TX. QUANTITY: 1 unit. REASON: Blood product, which was labeled with an expiration date that was extended by one day, was distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall # B-1392-1. CODE: Unit number 10709-0983. MANUFACTURER: Blood Systems, Inc., Scottsdale, AZ. RECALLED BY: Manufacturer, by telephone on March 15, 2001, and by letter dated April 4, 2001. Firm initiated recall is complete. DISTRIBUTION: AZ. QUANTITY: 1 unit. REASON: Blood product, that remained out of controlled storage for more than 30 minutes, was distributed. ________ PRODUCT: a) Red Blood Cells, Leukoreduced. b) Recovered Plasma Recall #B-1112-1. CODE: a) Unit 10625-0116 b) Unit 10625-0116 MANUFACTURER: Blood Systems, Inc., Chandler, AZ. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by telephone on July 31, 2000, and letter dated September 7, 2000. Firm initiated recall is complete. DISTRIBUTION: AZ. QUANTITY: 2 units. REASON: Blood products, collected from a donor who had taken antibiotics the day before donation, were distributed. ________ PRODUCT: Platelets, Pheresis. Recall # B-1314-1. CODE: Units V01583, V01584, V01596, V01622. MANUFACTURER: Community Blood Center of Greater Kansas, Topeka, KS. RECALLED BY: Manufacturer, by letter dated July 30, 1998. Firm initiated recall is complete. DISTRIBUTION: CA. QUANTITY: 4 units. REASON: Unlicensed blood products were distributed in interstate commerce. ________ PRODUCT: Red Blood Cells. Recall # B-1355-1. CODE: Unit number GX33038. MANUFACTURER: Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA. RECALLED BY: Manufacturer, by telephone and requested return of the unit. Firm initiated recall is complete. DISTRIBUTION: CA. QUANTITY: 1 unit. REASON: Blood product, labeled with the incorrect expiration date, was distributed. ________ PRODUCT: Red Blood Cells, Irradiated. Recall # B-1356-1. CODE: Unit numbers 0175462, 0175463, and 0175464. MANUFACTURER: New York United Hospital and Medical Center, Port Chester, NY. RECALLED BY: Manufacturer, by telephone on June 26, 2000 and letter dated June 27, 2000. Firm initiated recall is complete. DISTRIBUTION: NY. QUANTITY: 3 units. REASON: Blood products, labeled with the incorrect expiration date, were distributed. ________ PRODUCT: Platelets Pheresis, Leukoreduced. Recall # B-1361-1. CODE: Unit LL09389. MANUFACTURER: Blood Bank of the Redwoods, Santa Rosa, CA. RECALLED BY: Manufacturer, by fax transmissions dated January 21, 2000, and January 9, 2001. Firm initiated recall is complete. DISTRIBUTION: NY. QUANTITY: 1 unit. REASON: Blood product, collected from a donor who was exposed to meningitis, was distributed. ________ PRODUCT: Red Blood Cells. Recall # B-1365-1. CODE: Unit numbers 3771760, 3785470, and 3785726. MANUFACTURER: Gulf Coast Regional Blood Center,Houston, TX. RECALLED BY: Manufacturer, by letter via facsimile on February 12, 2000. Firm initiated recall is complete. DISTRIBUTION: TX. QUANTITY: 3 units. REASON: Blood products, that failed quality control testing for hematocrit and/or red blood cell volume, were distributed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT: Single Use Staplers as follows: a) AutoSuture Endo GIA* II 60mm 2.5mm Order Code: 030412. Recall #Z-0590-01 b) AutoSuture Endo GIA* II 60mm 3.5mm Order Code: 030414. Recall #Z-0591-01. CODE: a) Lot Numbers: N0M171, N0M252, N0M306, N1A107, N1A200, N1A286, N1B12, N1B105, N1C07, N1C65, N1C116 Order Code 030414 b) Lot Numbers: N0M250, N0M259, N0M260, N1A155, N1A18, N1A197, N1A224, N1A238, N1A239, N1A287, N1A333, N1A352, N1A82, N1A96, N1B157, N1B167, N1B211, N1B257, N1B284, N1B35, N1B86, N1C130, N1C35, N1C66 MANUFACTURER: United States Surgical Corp., North Haven, CT. RECALLED BY: Manufacturer, by letter on April 19, 2001. Firm initiated recall is ongoing. DISTRIBUTION: Nationwide, Canada, Japan, Brasil, Korea, France, Mexico, Columbia, Chile, New Zealand, Austria, and Switzerland. VA Medical Centers: Houston, TX, Richmond, VA QUANTITY: 36,370 units. REASON: The units may transect without all of the staples being placed into the tissue. ________ PRODUCT: a) Cryovalve Allograft. Recall # Z-533-1. b) Cryovalve Allograft. Recall # Z-534-1. CODE: a) Model No. AVOO, Serial No. 6087906; b) Model No. PVOO, Serial No. 6087914. MANUFACTURER: Cryolife, Inc., Kennesaw, GA. RECALLED BY: Manufacturer, by letter, on March 23, 2001. Firm initiated recall terminated. DISTRIBUTION: Reno, NV and Omaha, NE QUANTITY: 2 units. REASON: The donor did not meet the current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered. ________ PRODUCT: a) Philips Tomoscan M. Recall # Z-550-1. b) Philips Tomoscan EG. Recall # Z-551-1. c) Philips Tomoscan EG. Recall # Z-552-1. CODE: a) Philips Tomoscan M; b) Philips Tomoscan EG; c) Philips Tomoscan EG Compact. MANUFACTURER: Analogic Corportation, Peabody, MA. RECALLED BY: Manufacturer representative will replace the current CT control software with a software version 4.0 by July 31, 2001. Recall ongoing. DISTRIBUTION: U.S. and worldwide. QUANTITY: 48 units in the US, 367 units Worldwide. REASON: The diagnostic x-ray devices fail to conform to design specifications relating to the accomplishment of their intended purpose. ________ PRODUCT: a) DePuy Acclaim Total Elbow System Humeral 100 MM Component. Recall # Z-558-1. b) DePuy Acclaim Total Elbow System Bobbin Component. Recall # Z-559-1. CODE: a) Catalog No. 1722-11-990, Lot Nos. U37B21 and UX4JJ1; b) Catalog No. 1722-50-990, Lot No. U1TFE1. MANUFACTURER: DePuy Orthopaedics, Warsaw, IN. RECALLED BY: Manufacturer, by sales representative visits starting on January 8, 2001. Firm initiated recall is ongoing. DISTRIBUTION: California, Colorado, Massachusetts, Mississippi, Rhode Island and England. QUANTITY: 23 REASON: An incorrect taper angle was used during manufacture. ________ PRODUCT: Breathing Circuits (see below); a) King Systems brand Jackson-Rees Modification Breathing Circuits. Recall # Z-592-1. b) King Systems brand Mapleson D Breathing Circuit. Recall # Z-593-1. c) Ped F2 Pediatric Anesthesia Breathing Circuit. Recall #Z-594-1. d) Norman Elbow, individually packed [VETERINARY DEVICE]: Anesco brand Mapleson C Breathing Circuits. Recall #Z-595-1. CODE: I. King Systems brand Jackson-Rees Modification breathing circuits, as follows: A. Ref # 2-60775; Lots I2CN2, I2EH6, I2I15, I2LL3 and I2NX0; B. Ref # 370; lots I27U1, I2H13, I2JS4 and I2NN0; C. Ref # 3700; lots I28Z3, I2DM0 and I2JY6; D. Ref # 3701; lots I2757, I29U8, I2AV3, I2DV0, I2GG3, I2J64 and I2MB2; E. Ref # 3702; lot I2F31; F. Ref # 3703-375; lots I28M3, I2CD1, I2G40, I2MB3 and I2MB3; G. Ref # 37072-WSLN; lot I2GG4; H. Ref # 37237; lot I2JH1; I. Ref # 3731-366WS; lots I2BK5, I2DC5, I2F32, I2IF4 and I2MM3; J. Ref # 374; lots I2DC6, I2EJ4, I2GT4, I2H61, I2IF5 and I2K79; K. Ref # 374Z; lots I2EQ7, I2F33, I2GG6, I2IF6 and I2L94; L. Ref # 3741; lots I2758, I2847, I2AV4, I2EJ5, I2HP8, I2IS8, I2K80, I2MX2 and I2DM1; M. Ref # 3741-WSNZ; lots I28M4, I2D11 and I2MX3; N. Ref # 3742; lots I2A61, I2J65, I2KV3, I2PG7, 128M5 and 12MX4; O. Ref # 3743, lots I2IS9 and I2MX5; P. Ref # 3743-321WS; lots I28Z4, I2C03, I2GG5 and I2J66; Q. Ref # 3743-6031; lot I2557; R. Ref # 3743-WSN; lots I2CD2 and I2G41; S. Ref # 3745; lot I2MX6; T. Ref # 3771; lots I2D12, I2EJ6, I2GG7, I2KV4, I2N95 and I2DM2; U. Ref # 3771-WSN; lots I2558, I26I6, I27I4, I27U2, I2B33, I2CP7, I2E60 and I2FV6; V. Ref # 3771Z; lot I2HI4; W. Ref # 3772; lot I2MB4; X. Ref # 3772-WSN; lots I2559, I26I7, I2B34, I2CP8, I2E61, I2FV7, I2IF7, I2JS5 and I2L95; Y. Ref # 3773-WSN; lot I28M6; Z. Ref # 3775; lots I2DM3 and I2LN6; AA. Ref # 3775-WS; lot I2848; AB. Ref # 6072442P; lots I2FH3 and I2IH4; AC. Ref # 60740; lots I29V7, I2AW5, I2CE1, I2EL1, I2GI0, I2JH6, I2LP4 and I2PH0; AD. Ref # 60742; lots I26U5, I2906, I29V8, I2AW6, I2GI1, I2MY8 and I2PS0; AE. Ref # 60743; lots I28N2, I2AW7, I2DD7, I2F39, I2HF3, I2JH7 and I2MD1; AF. Ref # 60771; lots I2649, I2E69 and I2G12; AG. Ref # 60772; lots I2IH5 and I2MD2; AH. Ref # 60773; lots I2767, I29J5, I2F93, I2JH8, I2LA1 and I2MD3; AI. Ref # 61740; lot I2KA0; AJ. Ref # 61743; lots I2CQ9, I2EL2 and I2JS9; AK. Ref # 61750; lots I26J3, I27J9, I29V9, I2BC0, I2CR0, I2EL3, I2GW6, I2IH6, I2JT0, I2LA3 and I2Q33; AL. Ref # 61772; lots I26U6, I27K0, I2BL1 and I2HF4; AM. Ref # 61773; lots I27K1, I2B42, I2E70, I2FW6, I2HF5, I2JT1 and I2LA4; AN. Ref # FGL3740; lots I2DP6 and I2G91. II. King Systems brand Mapleson D breathing circuits, as follows: A. Ref # 4710-101; lot I2GT5; B. Ref # 4740; lots I2B39 and I2JH2; C. Ref # 4741; lots I29E1 and I2CQ3; D. Ref # 4760; lot I28M8; E. Ref # 4762; lots I28Z9, I2BL0, I2H64 and I2N99. III. Ped F2 Pediatric Anesthesia Breathing Circuit, Ref # F90542; lot I2A06. IV. Norman elbow, individually packaged, Ref # 838-052-100P; lot I28Q1. V. [VETERINARY DEVICE]: Anesco brand Mapleson C breathing circuits, Ref # A1003; lot I2H29. ANESCO, P.O. Box 492, Georgetown, Kentucky. MANUFACTURER: King Systems Corporation, Noblesville, IN. RECALLED BY: Manufacturer, by certified mail on January 30, 2001. Firm initiated recall ongoing. DISTRIBUTION: United States, Canada, Japan and Mexico. QUANTITY: 21,680 REASON: There is a possible obstruction of the fresh gas inlet of the elbow. ________ PRODUCT: NexGen Knee Threaded Fixation Pin. Recall # Z-596-1. CODE: Catalog No. 00-5978-013-00, Lot Nos. 71350300, 71915000. MANUFACTURER: Zimmer, Inc., Warsaw, IN. RECALLED BY: Manufacturer, by letter, on April 2, 2001. Firm initiated recall ongoing. DISTRIBUTION: United States, Australia, Belgium, Canada Germany, Italy, Japan and the United Kingdom. QUANTITY: 708 REASON: The hex end of the pin is incorrect and will not assemble with the driver to secure the Micro-Mill femoral mounting base instrumentation to the surgical site. ________ PRODUCT: a) 1000464 5F AtheroCath Bantam Atherectomy Catheter. Recall # Z-597-1. b) 1000465 6F AtheroCath Bantam Atherectomy Catheter. Recall # Z-598-1. c) 1000466 7F AtheroCath Bantam Atherectomy Catheter; Recall # Z-599-1. d) 20344-01 5mm 6F AtheroCath SCA-EX Atherectomy Catheter. Recall # Z-600-1. e) 20345-01 5mm 7F AtheroCath SCA-EX Shortcutter Atherectomy Catheter. Recall # Z-602-1. f) 20354-01 6F AtheroCath GTO Atherectomy Catheter. Recall # Z-603-1 g) 20355-01 7F AtheroCath GTO Atherectomy Catheter. Recall # Z-604-1. h) 20361-01 7FG SCA-EX (Graft) AtheroCath Atherectomy Catheter. Recall # Z-605- 1. CODE: All codes. MANUFACTURER: Guidant Corporation, Temecula, CA. RECALLED BY: Manfacturer, by letter dated December 11, 2000. Firm initiated recall is terminated. DISTRIBUTION: Japan QUANTITY: 829 units. REASON: Tip of artherectomy catheter dislodged in a patient during procedure. END OF ENFORCEMENT REPORT FOR June 13, 2001. ####
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