April 24, 2002 02-16
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT Frozen Black Groupers, sold as whole or fillets. Recall # F-378-2. CODE Black groupers received from A Fishersman's Best Co. were uncoded; however, these included all frozen Black groupers shipped from 10/14/01 to 10/29/01 to various accounts and were received under Customs Entry # D97-0213932-7. RECALLING FIRM/MANUFACTURER A Fisherman's Best, Dania, FL, by telephone on November 1, 2001. FDA initiated recall is complete. REASON Black groupers may contain ciguatera toxin. VOLUME OF PRODUCT IN COMMERCE 3781 lbs. whole fish. DISTRIBUTION FL, IN, OH, SC, NC, TN, NJ, PA, TX and Canada.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________ PRODUCT Crunch Pak brand Sliced Apples: 2 oz., 6 oz., 6.75 oz. And 1 lb in poly bags; 3 lb. and 30 lb. in containers. Labeling states in part "CRUNCH PAK ** FRESH PRODUCTS NORTHWEST ** WENATCHEE, WA ***". Recall # F-377-2. CODE "Best If Used By" 10/16/01, 10/17/01, 10/18/01, 10/21/01, 10/22/01, 10/23/01, 10/24/01, 10/25/01, 10/28/01, 10/29/01, 10/30/01, 10/31/01, 11/01/01, 11/02/01, 11/03/01, or 11/04/01. RECALLING FIRM/MANUFACTURER Fresh Products Nortwest LLC, Wenatchee, WA, by letter on October 17, 2001. Firm initiated recall is complete. REASON Apple slices contain undeclared calcium ascorbate. VOLUME OF PRODUCT IN COMMERCE 216,755 lbs. DISTRIBUTION AZ, CA, CO, OH, OK, OR, SC, TX, UT, and WA.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-1059-2; b) Red Blood Cells, Leukoreduced, Irradiated, Recall # B-1060-2. CODE a) Units 23144-8920, 23144-8928; b) Units 23144-8926, 23144-8935, 23144-8936, 23144-8937. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Billings, MT, by telephone on October 30, 2001. Firm initiated recall is complete. REASON Blood products, which were incorrectly tested for Cytomegalovirus (CMV), were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION WY and MT. _______________________ PRODUCT Red Blood Cells, Recall # B-1062-2. CODE Units 011KE11993, 011KE11997, 011KE11967. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Missouri-Illinois Region, St. Louis, MO, by telephone on June 11, 1999 and by letter dated June 29, 1999. Firm initiated recall is complete. REASON Blood products, collected in a manner that may have compromised the sterility of the unit, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION MO. _______________________ PRODUCT Platelet, Pheresis, Recall # B–1063-2. CODE Unit K17385. RECALLING FIRM/MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, IA, by telephone on October 11, 2000 and by letter on October 12, 2000. Firm initiated recall is complete. REASON Blood products, which had an unacceptable platelet count, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MO. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1087-2. CODE Unit number 38FK17266. RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by letter dated November 2, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IN. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1088-2. CODE Unit number 13GC95045. RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter dated November 9, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1089-2; b) Platelets, Recall # B-1090-2. CODE a) and b) Unit number 6622751. RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by letter dated February 27, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IN. _______________________ PRODUCT Whole Blood, Recall # B-1091-2. CODE Unit number 13J29694. RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letters on October 11, 2001 and November 16, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor that tested positive for the Kell antigen, but may have been labeled Kell antigen negative, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _______________________ PRODUCT Red Blood Cells Leukocytes Removed, Recall # B-1092-2. CODE Unit 12471-2036. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Albuquerque, NM, by letter dated February 14, 2002. Firm initiated recall is ongoing. REASON Blood product, which was collected from a donor who visited a malaria endemic area, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1098-2. CODE Unit number 12471-2035. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated February 14, 2002. Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is ongoing. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1099-2. CODE Unit number 12470-3574. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated February 14, 2002. Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is ongoing. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NM. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1110-2. CODE Unit number 42FE67760. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH, by letter on January 8, 2002. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor due to use of the medication Coumadin at the time of donation, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _______________________ PRODUCT Red Blood Cells, Recall # B-1102-2. CODE Unit number 21KG47266. RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR, by letter on August 17, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Washington, DC _______________________ PRODUCT a) Red Blood Cells, Recall # B-1103-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-1104-2; c) Plasma, Recall # B-1105-2. CODE a)Unit numbers 21KL15388 and 21KH24045; b)Unit number 21KQ05182; c)Unit numbers 21KL15388, 21KH24045, and 21KQ05182. RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR, by letter on August 28, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a disclosure of previous positive hepatitis testing, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION OR and PA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1106-2 CODE Unit number 21KG55604. RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR, by letters on November 15 and December 26, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OR. _______________________ PRODUCT Red Blood Cells, Recall # B-1107-2. CODE Unit number 21KC31335. RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR, by letter on December 10, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OR. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1108-2. CODE Unit number 21KG52294. RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region,Portland, OR, by letter on November 5, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OR. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1109-2. CODE Unit number 21KF24356. RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR, by letter February 4, 2002. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OR. _______________________ PRODUCT Red Blood Cells, Recall # B-1111-2. CODE Unit number GL77982. RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino and Riverside Counties, San Bernadino, CA, by letter on September 4, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _____________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1112-2 CODE Unit number 13FS93627. RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter dated January 8, 2002. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _______________________ PRODUCT Human Tissue for Transplantation (various types) manufactured between November 1, 2000, and April 30, 2001 and packaged in peel pack type packaging, Recall # B-1124-2. 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RECALLING FIRM/MANUFACTURER AlloSource, Englewood, CO, by telephone and follow-up letter beginning May 23, 2001. Firm initiated recall is complete. REASON Human tissue for transplantation, that tested negative for microorganisms, but was manufactured during a period when multiple positive results for mold were found in the manufacturing facility and on other products, was distributed. VOLUME OF PRODUCT IN COMMERCE 1740 tissues. DISTRIBUTION Nationwide, Canada and Korea.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Platelets Leukocytes Removed, Recall # B-1086-2. CODE Unit 33GR34220. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Connecticut Region, Farmington, CT, by telephone on February 4 and by letter on February 11, 2002. Firm initiated recall is complete. REASON Blood product, which was manufactured from a whole blood unit that was incorrectly tested for red cell antibodies, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CT.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
_______________________ PRODUCT a) Zoll M Series Advisory Defibrillator. Recall # Z-0893-2; b) Zoll M Series AED Defibrillator (semi automatic defibrillator). Recall # Z-0894-2. CODE a) Serial Numbers: T98F00046-T01K27762 with System Software Version below 30.00 b) Serial Numbrs: T98F0092-T01J27533 with System Software Version below 30.0. RECALLING FIRM/MANUFACTURER Zoll Medical Corp., Burlington, MA, by letter on December 18, 2001. Firm initiated recall is ongoing. REASON Defibrillator may fail to detect ventricular fibrillation and fail to deliver shock. VOLUME OF PRODUCT IN COMMERCE 13,667. DISTRIBUTION Nationwide and worldwide.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
******CORRECTION******
On the April 3, 2002 Enforcement Report, Recall # Z 596-2, DynaGraft Gel and Putty, a mixture of human demineralized allograft bone powder mixed with a reverse-phase medium and formulated into a gel or putty consistency was listed as a Class III and it is a Class II. _______________________ PRODUCT a) Hi Torque Balance Middle Weight Guide Wire. Recall # Z-0828-2; b) Dock Extension Wire. Recall # Z-0829-2. Guide Wires intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal angioplasty. CODE a) Part number:1001780J Lot 1120851. b) Part number: 22260 Lot 1111551. RECALLING FIRM/MANUFACTURER Guidant Corp., Temecula, CA, by visit, phone and fax on January 29, 2002. Firm initiated recall is complete. REASON Sterility compromised. VOLUME OF PRODUCT IN COMMERCE 789. DISTRIBUTION Nationwide and Poland, Japan and Italy. _______________________ PRODUCT Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system. Recall # Z-0830-2. CODE 0998-00-170-0002(A) 0998-00-170-0005(A) 0998-00-170-0006(A) 0998-00-170-0010(A,F) 0998-00-170-0011(A) 0998-00-170-0012(A) 0998-00-170-0013(A) 0998-00-170-0014(A,D,F,T) 0998-00-170-0015(A) 0998-00-170-0016(A) 0998-00-170-0025(A) 0998-00-170-0030(A) 0998-00-170-0032(A) 0998-00-170-0038(A,P) 0998-00-170-0042(A) 0998-00-170-0045(A) 0998-00-170-0046(A,F,G,P) 0998-00-170-0048(A) 0998-00-170-0058(A) 0998-00-170-3014(A,T) 0998-00-170-3015(A) 0998-00-170-3016(A) 0998-00-170-3038(G) 0998-00-170-3040(A) 0998-00-170-3046(A,P) 0998-00-170-3048(A,G,P). RECALLING FIRM/MANUFACTURER Datascope Corp., Mahwah, NJ, by mail on January 17, 2002. Firm initiated recall is ongoing. REASON Power Supply problems for the monitor may shut down without notice. VOLUME OF PRODUCT IN COMMERCE 203. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Ventrix NL950-V Ventricular Tunneling Pressure Monitoring Kit; consists of a sterile, transducer tipped catheter that is used to continuously monitor intracranial pressure and drain cerebrospinal fluid. Kit includes a trocar, introducer stylet, suture loops, a drill bit and hex wrench. Recall #Z-0831-2. CODE V1299 V1300A V1301 V1302 V1303 V1304 V1305 V1306 V1307 V1308 V1309 V1310 V1311 V1312 V1313 V1314 V1315 V1316 V1317 V1318 V1319 V1320 V1321 V1322 V1323 V1324 V1325 V1326 V1327 V1330 V1331 V1052 V1053 V1054. RECALLING FIRM/MANUFACTURER Integra Neurocare LLC., San Diego, CA, by letter dated March 8, 2002. Firm initiated recall is ongoing. REASON Directions have blank pages. VOLUME OF PRODUCT IN COMMERCE 806 units. DISTRIBUTION Nationwide and Australia, Brazil, Colombia, Chile, England and France. _______________________ PRODUCT Portex Hypodermic NEEDLE-PRO Needle with Needle Protection Device (Small Gauge Safety), Sterile: a) Catalog No. 4320 (25g x 5/8"). Recall # Z-0832-2; b) Catalog No. 4322 (26g x 1/2"). Recall # Z-0833-2; c) Catalog No. 4323 (27g x 1/2"). Recall # Z-0834-2. CODE a) Lot Nos.: K102024; b) Lot Nos: 111914, 111917, and K102025; c) Lot No.: K102026. RECALLING FIRM/MANUFACTURER Portex, Inc., Keene, NH, by letter on March 19, 2002. Firm initiated recall is ongoing. REASON Sterility of the device may be compromised due to a loss of package integrity. VOLUME OF PRODUCT IN COMMERCE 74,045 units. DISTRIBUTION Nationwide. _______________________ PRODUCT SoftPerm Daily Wear Soft (Hydrophilic) Contact Lens. Recall # Z-0835-2. CODE Lot Number 40114586200611, exp. 2006/11. RECALLING FIRM/MANUFACTURER Ciba Vision Corp. Duluth, GA, by telephone on March 1, 2002. Firm initiated recall is ongoing. REASON Improper sterilization cycle. VOLUME OF PRODUCT IN COMMERCE 8 individual lenses. DISTRIBUTION CA, MA, MS, NY, OH, OR & WV and Nova Scotia. _______________________ PRODUCT Boston Scientific/Medi-Tech RENEGADE Hi-Flo Microcatheter Kit. Recall # Z-0836-2. CODE Catalog No. Product Description Lot Number Exp. Date 18-303 RENEGADE HI FLO 135/20 KIT 4500101 12/01/2003 4503702 12/01/2003 4519516 01/01/2004 4551582 01/01/2004. RECALLING FIRM/MANUFACTURER Recalling Firm: Boston Scientific Corp./Medi-Tech Natick, MA, by letter between March 19 and 22, 2002. Manufacturer: Medi-Tech a division of Boston Scientific Corp., Watertown, MA. Firm initiated recall is complete. REASON Kit packaged with an incorrect quidewire length of 135 cm instead of 165 cm. VOLUME OF PRODUCT IN COMMERCE 46. DISTRIBUTION CA, FL, MI, NY, SC and TX. _______________________ PRODUCT Cordis Temp 4F Diagnostic Catheter WITH THE FOLLOWING CATALOG NUMBERS OR ITEM NUMBERS (SEE CODES SECTION FOR CORRESPONDING LOT NUMBERS UNDER RECALL): 451406H0, 451406H2, 451406P0, 451406P2, 451406S0, 451406S2, 451406V0, 451407H2, 451407S2, 451407V0, 451413H0, 451413V0, 451414H0, 451415H0, 451415V0, 451423H0, 451424H0, 451425H0, 451430H0, 451430H2, 451431H0, 451431H2, 451432H0, 451435H0, 451442V0, 451442V2, 451443H0, 451443V0, 451443V2, 451444V0, 451444V2, 451446S0, 451446V2, 451447S0, 451447S2, 451449V0, 451450V0, 451457V0, Total Items38 Recall # Z-0839-2-0876-2. CODE LOT NUMBER ITEM NUMBER R0101089 451406H0 R0101210 451406H2 R0101214 451406P0 R0101319 451406P2 R0101320 451406S0 R0101471 451406S2 R0101512 451406V0 R0101680 451407H2 R0101820 451407S2 R0101821 451407V0 R0101822 451413H0 R0101911 451413V0 R0101913 451414H0 R0201062 451415H0 R0201064 451415V0 R0201140 451423H0 R0201460 451424H0 R0201552 451425H0 R0201686 451430H0 R0201687 451430H2 R0201688 451431H0 R0201689 451431H2 R0201690 451432H0 R0201870 451435H0 R0201958 451442V0 R0201959 451442V2 R0301044 451443H0 R0301045 451443V0 R0301279 451443V2 R0301281 451444V0 R0301496 451444V2 R0301574 451446S0 R0301575 451446V2 R0301714 451447S0 R0301779 451447S2 R0301897 451449V0 R0301899 451450V0 R0900022 451457V0 R0900175 Total Items38 R0900267 R0900367 R0900514 R0900515 R0900635 R0900730 R1000075 R1000196 R1000333 R1000335 R1000533 R1000534 R1000535 R1000536 R1000653 R1000922 R1000927 R1000983 R1000984 R1100042 R1100043 R1100046 R1100072 R1100311 R1100312 R1100747 R1100748 R1100827 R1100862 R1100932 R1100933 R1100935 R1100936 R1200003 R1200139 R1200357 R1200475 R1200567 R1200568 S0101190 S0101191 S0101193 S0101194 S0101305 S0101334 S0101640 S0101643 S0101645 S0101646 S0101651 S0101760 S0101761 S0101762 S0201023 S0201025 S0201059 S0201060 S0201351 S0201352 S0201502 S0201680 S0201859 S0201931 S0201935 S0301209 S0301210 S0301212 S0301240 S0301427 S0900105 S0900167 S0900168 S0900260 S0900262 S0900512 S0900515 S0900517 S0900637 S0900741 S0900742 S0900743 S1000063 S1000084 S1000085 S1000174 S1000368 S1000375 S1000376 S1000541 S1000574 S1000709 S1000710 S1000850 S1100019 S1100060 S1100061 S1100252 S1100253 S1100254 S1100255 S1100256 S1100257 S1100362 S1100490 S1100800 S1100936 S1100937 S1200070 S1200071 S1200072 S1200226 S1200610 S1200789 S1200790 S1200791 W0101028 W0101033 W0101092 W0101093 W0101157 W0101401 W0101506 W0201079 W0201080 W0201081 W0201170 W0201171 W0301027 W0301116 W0800231 W0800232 W0800233 W0800373 W0800465 W0800466 W0800469 W0800740 W0800743 W0900305 W1000248 W1000252 W1000253 W1000376 W1000377 W1000378 W1000379 W1000380 W1000381 W1000477 W1100025 W1100027 W1100029 W1100030 W1100337 W1100338 Total Lots 194 RECALLING FIRM/MANUFACTURER Recalling Firm: Cordis Corp., Miami Lakes, FL, by letter dated May 23, 2001. Manufacturer: Cordia Europa Roden, Netherlands. Firm initiated recall is ongoing. REASON Instances of catheter tip separation. VOLUME OF PRODUCT IN COMMERCE 11,255. DISTRIBUTION Nationwide and Brazil, Canada, Puerto Rico, Argentina and Mexico. _______________________ PRODUCT Liver Dialysis Unit: Treatment Kit/Disposable Pack. Recall # Z-0877-2. This is a disposable, single use kit used during dialysis. CODE Serial numbers 00041-44 thru 00050-77. RECALLING FIRM/MANUFACTURER Recalling Firm: HemoTherapies, Inc., San Diego, CA, by issuing Returned Goods Authorizations beginning about October 27, 2001. Manufacturer: HemoCleanse, Inc., Rochester, NY. Firm initiated recall is ongoing. REASON The filtrate generator was installed backwards, causing tension and crimping in the tubing line. VOLUME OF PRODUCT IN COMMERCE 13. DISTRIBUTION MN, NY and AZ. _______________________ PRODUCT Liver Dialysis Unit Machine (LDU1) and Treatment Kits. Recall # Z-0878-2. CODE All codes. RECALLING FIRM/MANUFACTURER Recalling Firm: HemoTherapies, Inc., San Diego, CA, by letter dated June 22, 2001. Manufacturer: UMM Electronics Inc., Indianapolis, IN. Firm initiated recall is ongoing. REASON Electronic controler board overheats causing alarm and device failure. VOLUME OF PRODUCT IN COMMERCE 21. DISTRIBUTION Nationwide. _______________________ PRODUCT Gray Tip Drill, 1 x 0.126 x 8". Recall # Z-0879-2. CODE Catalog Number 5800-8-125 Lot Code: K700436. RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ, by letters on December 13, 2001. Manufacturer: Stryker Trauma GmbH, D24232 Schoenkirchen, Germany. Firm initiated recall is complete. REASON Gray Tip Drill mislabeled as lag screw. VOLUME OF PRODUCT IN COMMERCE 201. DISTRIBUTION Nationwide. _______________________ PRODUCT Liver Dialysis Unit Machines and kits. (aka LDU2) Product was previously named BioLogic DT System with BioLogic DT TK1000 kits. Recall # Z-0880-2. CODE All units all codes. RECALLING FIRM/MANUFACTURER Recalling Firm: HemoTherapies Inc., San Diego, CA, by letters dated June 22, 2001. Manufacturer: UMM Electronics, Inc., Indianapolis, IN. Firm initiated recall is complete. REASON Units alarm and shut down for unexplained reason. VOLUME OF PRODUCT IN COMMERCE 6. DISTRIBUTION MA, IL and LA. _______________________ PRODUCT Caleo Infant Warming System. The product is an incubator. The device provides access for minor surgical procedures and allows endotracheal intubation without having to slide the baby out of the incubator. Recall # Z-0881-2/Z-0885-2. CODE Catalog numbers 4117025-006, 4117025-007, 4117025-008, 4117025-009, and 4117025-018. The following serial numbers were distributed in the US: ARRE-0026, ARRE-0027, ARRF-0006, ARRF-0008, ARRJ-0021, ARRJ-0019, ARRJ-0020, ARRJ-0024, ARRJ-0029, ARRJ-0030, AARJ-0031, AARJ-0032, AARJ-0033, ARRK-0002, ARRK-0023, ARRK-0029, ARRM-0274, ARRM-0275, ARRM-0276, ARRM-0277, ARRM-0278, ARRM-0279, ARRM-0281, ARRN-0033, ARRN-0038, ARRN-0335, ARRN-0036, ARRN-0037, ARRN-0038, ARRN-0039, ARRN-0040, ARRN-0041, ARRN-0042, and ARRN-0043. The following serial numbers were distributed in Canada: ARPN-0028, ARRF-0007, ARRF-0009, ARRH-0027, ARRH-0028, ARRH-0029, ARRH-0030, ARRH-0031, ARRH-0039, ARRH-0040, ARRH-0041, ARRJ-0010, ARRJ-0011, ARRJ-0012, ARRJ-0013, ARRJ-0014, ARRJ-0015, and ARRJ-0070. RECALLING FIRM/MANUFACTURER Recalling Firm: Drager Medical Inc Telford, PA, by letters on March 13, 2002. Manufacturer: Drager Medical AG & Co KGaA Lubeck, Germany. Firm initiated recall is ongoing. REASON May short circuit. VOLUME OF PRODUCT IN COMMERCE 56 units. DISTRIBUTION CA, FL, GA, MO, NY, OH, TX, and Canada. _______________________ PRODUCT a) Polarus Humeral Rod System, part #HCO3275-S, 3.5mm x 27.5mm b) Cortical Screw, and part #HCO3325-S, 3.5mm x 32.5mm Cortical Screw. The Polarus Humeral Rod System is a system of rods and screws for the fixation of humeral fractures and their accompanying instrumentation. Recall # Z-0886-2/Z-0887-2. CODE a) Lot #W02947 b) Lot #W02508. RECALLING FIRM/MANUFACTURER Acumed, Inc., Beaverton, OR, by fax or e-mail on January 31, 2002. Firm initiated recall is complete. REASON Extended sterilization expiration date. VOLUME OF PRODUCT IN COMMERCE Part #HCO3275-S - 143 Part #HCO3325-S – 81. DISTRIBUTION Nationwide. _______________________ PRODUCT Misys Laboratory for Windows version 5.3. Recall # Z-0888-2. CODE Versions 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., aka Misys Healthcare Systems Tucson, AZ, by a temporary procedural workaround March 8, 2002. Firm initiated recall is ongoing. REASON Software QA code of BOTH for patient sex can result in QA flags not being generated for abnormal results. VOLUME OF PRODUCT IN COMMERCE 345. DISTRIBUTION Nationwide, internationally to United Kingdom, Ireland, Denmark, Canada, Bermuda and Saudi Arabia. _______________________ PRODUCT Avanta Orthopaedics, Proximal Radial Head Stem, Product Code RHA- S2, Lot RS0099. Recall # Z-0889-2. CODE Lot RS0099. RECALLING FIRM/MANUFACTURER Avanta Orthopaedics, Inc., San Diego, CA, by telephone on March 14, 2002. Firm initiated recall is complete. REASON Label mix-up. Incorrect size on label. VOLUME OF PRODUCT IN COMMERCE 6. DISTRIBUTION TX, OH and Netherlands, Spain and Australia. _______________________ PRODUCT a) Integris Allura X-ray system with Ultrasound option. The Integris Alluras x-ray system is used as an imaging device for: dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures; cardiac imaging applications including diagnostics, interventional procedures, pacemaker implantations, and electrophysiology; non-vascular interventions such as drainage and biopsies. Recall # Z-0890-2; b) MultiDiagnost 3 with Ultrasound Option. Recall # Z-0891-2 c) MultiDiagnost 4 with Ultrasound Option The MultiDiagnost 3 and MultiDiagnost 4 are multi functional/universal systems used for general R/F. Fluoroscopy, Radiography and Angiography can be performed with other specialized interventional applications. The ultrasound system is used for diagnostic ultrasound imaging or fluid flow analysis of the human body. Recall # Z-0892-2. CODE 9896 001 40621, 9896 000 12821. RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated March 28, 2002. Manufacturer: Philips Medical Systems Nederland, B.V. 5680 Da Best, Netherlands. Firm initiated recall is ongoing. REASON Potential for supporting arm and keyboard to strike patient. VOLUME OF PRODUCT IN COMMERCE 94. DISTRIBUTION Nationwide.END OF ENFORCEMENT REPORT FOR APRIL 24, 2002 ####
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