January 8, 2003 03-02
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_____________________________ PRODUCT Assorted Chocolates. Daffins Fine Candies Choice Assortment in 10 oz, 1 lb, and 2 lb boxes. Recall # F-117-3. CODE All lots manufactured prior to 10/1/02. RECALLING FIRM/MANUFACTURER Daffins Candies, Farrell, PA, by press release on October 1, 2002. FDA initiated recall is complete. REASON Assorted Chocolates contained undeclared egg albumen. VOLUME OF PRODUCT IN COMMERCE 588 (10 oz), 1143 (1 lb), and 194 (2 lb) boxes. DISTRIBUTION PA and OH. _____________________________ PRODUCT White Chocolate Raspberry Cheesecake, packaged and cut ready to thaw and eat. Four cakes per case. Recall # F-118-3. CODE Lot 22000201A1. RECALLING FIRM/MANUFACTURER Cheesecake Factory Bakery, Calabasas, CA, by telephone on August 1, 2002. Firm initiated recall is complete. REASON Listeria monocytogenes. VOLUME OF PRODUCT IN COMMERCE 667 cases. DISTRIBUTION MO, TX, AR, KS, LA, OK. _____________________________ PRODUCT Smoked Trout. Recall # F-119-3. CODE Lot 0621. RECALLING FIRM/MANUFACTURER Eden Brook Fish Market, Inc., Monticello, NY, by press release on July 3, 2002. State initiated recall is complete. REASON The product was contaminated with Listeria monocytogenes. VOLUME OF PRODUCT IN COMMERCE 35 lbs. DISTRIBUTION NY. _____________________________ PRODUCT l'or des Domes brand St. Nectaire cheese (au lait entier), packed in paper-wrapped wheels, each weighing approximately 4 lbs. Recall # F-121- 3. CODE On sticker label: Lot number 0004114 Production Date 19/04/02 which represents April 19, 2002. BarCODE # 2348 7439 RECALLING FIRM/MANUFACTURER Recalling Firm: De Choix Specialty Foods Company, Woodside, NY, by press release and letter issued on June 20, 2002. Manufacturer: Societe Fromagere de Tauves 63690 Tauves. FDA initiated recall is complete. REASON The product was contaminated with Listeria monocytogenes. VOLUME OF PRODUCT IN COMMERCE 59 wheels of cheese were distributed. DISTRIBUTION NY, PA, CA, IL, OH and VA. _____________________________ PRODUCT EGO brand Famous Dried Mangoes in heat sealed plastic bags, net wt. 7.05 oz. (200 g). Product of Malaysia. UPC barCODE # 29173 10309. Recall # F-122-3. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Starway Inc., Brooklyn, NY, by press release on June 18, 2002. Manufacturer: Kee Wee Hup Kee Food Manufacture PTE Ltd. Singapore. State initiated recall is complete. REASON The product contained undeclared sulfites (147 ppm). VOLUME OF PRODUCT IN COMMERCE 1 case (50 - 7.5 oz. packages per case) was distributed. DISTRIBUTION NY.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_____________________________ PRODUCT Human tissue for transplantation of the following types from Donor ID #s D0102466 and D0102484: Recall # B-0300-3. Cancellous Chips; Canc/cort dowel; Patellar Block; Graftech cervical spacer; Graftech cortical spacer ; Graftech cortical spacer-long; Graftech posterior ramp; Graftech posterior ramp long; Femur head; Cort/canc dental powder; DBF Matrix. CODE Units D01024660021, D01024660022, D01024660023, D01024660024, D01024660025, D01024660026, D01024840003, D01024840004, D01024840005, D01024840006, D01024840007, D01024840008; Units D01024660017, D01024660018, D01024660019, D01024660020, D01024660046 Units D01024660044, D01024660045; Units D01024660029, D01024660030, D01024660031, D01024660032, D01024660033, D01024660034, D01024660035, D01024660036, D01024660037, D01024660038, D01024660039, D01024660040, D01024660041; Units D01024660111, D01024660112, D01024660113, D01024660114, D01024660115, D01024660116, D01024660117, D01024660118, D01024660119, D01024660120, D01024660121, D01024660122, D01024660123, D01024660124, D01024660125, D01024660126, D01024660127, D01024660128, D01024660129; Units D01024660107, D01024660108, D01024660109, D01024660110; Units D01024660078, D01024660079, D01024660080, D01024660081, D01024660082, D01024660083, D01024660084, D01024660085, D01024660086, D01024660087, D01024660088, D01024660089, D01024660090, D01024660091, D01024660092, D01024660093, D01024660094, D01024660095, D01024660096, D01024660097, D01024660098, D01024660099, D01024660100, D01024660101, D01024660102, D01024660103, D01024660104, D01024660105, D01024660106; Units D01024660074, D01024660075, D01024660076, D01024660077; Units D01024660001, D01024660002; Unit 01024660502; Unit D01024840043. RECALLING FIRM/MANUFACTURER American Red Cross Tissue Services, Lorton, VA, by telephone on September 30, 2002 and by letter dated October 7, 2002. Firm initiated recall is complete. REASON Human tissues for transplantation were distributed and were subsequently reported to have tested repeatedly reactive for hepatitis B surface antigen (HBsAg). VOLUME OF PRODUCT IN COMMERCE 126 units. DISTRIBUTION Nationwide. _____________________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0351-3; b) Red Blood Cells, Recall # B-0352-3. CODE a) Units LN51836, LN50030; b) Unit FQ23844. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on August 31, 2001 and by letter dated September 4, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who should have been deferred due to use of the drug Cytotec, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION WI. _____________________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0355-3; b) Platelets, Recall # B-0356-3. CODE a) and b) Unit 32KN04017. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Badger-Hawkeye Region, Madison, WI, by letter dated April 19, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt Jakob Disease (nvCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IL. _____________________________ PRODUCT Source Plasma, Recall # B-0365-3 CODE 98OWIA0594, 98OWIA1197, 98OWIA1814, 98OWIA2511, 98OWIA3161, 98OWIA3846, 98OWIA4447, 98OWIA5844, 98OWIA6621, 98OWIA7344, 98OWIA8105, 98OWIA8796, 98OWIA9532, 98OWIB0118, 98OWIB0754, 98OWIB1436, 98OWIB2328, 98OWIB3696, 98OWIB3783, 98OWIB6843, 98OWIB7678, 98OWIB8303, 98OWIC4340, 98OWIC5400, 98OWIC6657, 98OWIC7277, 98OWIC7854, 98OWIC9050, 98OWID1265, 98OWID1793, 98OWID2343, 98OWID2924, 98OWID3493, 98OWID4037, 98OWID4600, 98OWID5074, 98OWID5639, 98OWID6740, 98OWID7240, 98OWID7810, 98OWID8356, 98OWID8933, 98OWID9473, 98OWIE0058, 98OWIE1096, 98OWIE1681, 98OWIE2227, 98OWIE2843, 98OWIE3403, 98OWIE4018, 98OWIE4630, 98OWIE5276, 98OWIE5904, 98OWIE6495, 98OWIE7095, 98OWIF0287, 98OWIF0987, 98OWIF1658, 98OWIF2305, 98OWIF2993, 98OWIF3663, 98OWIF4422, 98OWIF6190, 98OWIF6949, 98OWIF9728, 98OWIG0134,99OWIA2983, 99OWIA3574, 99OWIA4152, 99OWIA4708, 99OWIA5277, 99OWIA7824, 99OWIA8489, 99OWIA9078, 99OWIA9741, 99OWIB0396, 99OWIB1767, 99OWIB2487, 99OWIB3024, 99OWIB3558, 99OWIB4229, 99OWIB4955, 99OWIB5634, 99OWIB7622, 99OWIB8274, 99OWIB8964, 99OWIB9608, 99OWIC0291, 99OWIC0942, 99OWIC1600, 99OWIC2221, 99OWIC3550, 99OWIC4134, 99OWIC4697, 99OWIC5287, 99OWIC5850, 99OWIC6375, 99OWIC7988, 99OWIC8517, 99OWIC9085, 99OWIC9654, 99OWID0224, 99OWID0786, 99OWID1391, 99OWID1977, 99OWID2447, 99OWID3022, 99OWID3733, 99OWID4453, 99OWID5090, 99OWID5838, 99OWID6480, 99OWID7206, 99OWID7830, 99OWID8580, 99OWID9209, 99OWID9963, 99OWIE0581, 99OWIE1333, 99OWIE1960, 99OWIE2740,99OWIE3373, 99OWIE4074, 99OWIE4715, 99OWIE5483, 99OWIE6116, 99OWIE6852, 99OWIE7473, 99OWIE8203, 99OWIE8848, 99OWIE9578, 99OWIF0190, 00OWID0680, 00OWID1253, 00OWID2396, 00OWID2942, 00OWID3539, 00OWID4112, 00OWID4698, 00OWID5218, 00OWID5788, 00OWID6301. RECALLING FIRM/MANUFACTURER Recalling Firm: Community Bio-Resources, Inc., Hoover, AL, by fax dated November 30, 2000. Manufacturer: Community Bio-Resources, Inc., Oshkosh, WI. Firm initiated recall is complete. REASON Blood products, collected from a donor whose health history screening was inadequately performed, were distributed VOLUME OF PRODUCT IN COMMERCE 140 units. DISTRIBUTION MI and Austria. _____________________________ PRODUCT Source Plasma, Recall # B-0368-3. CODE Units 00OWIC0289, 00OWIC0251, 00OWIC1554, 00OWIC1981, 00OWIC3195, 00OWIC4571, 00OWIC5739, 00OWIC6872, 00OWID3484. RECALLING FIRM/MANUFACTURER Recalling Firm: Community Bio-Resources, Inc., Hoover, AL, by fax dated July 26, 2000 or August 28, 2000. Manufacturer: Community Bio-Resources, Inc., Oshkosh, WI. Firm initiated recall is complete. REASON Blood products, collected from a donor who had not completed the CJD/nvCJD increased risk questions, were distributed. VOLUME OF PRODUCT IN COMMERCE 9 units. DISTRIBUTION MI and Austria. _____________________________ PRODUCT Source Plasma, Recall # B-0369-3. CODE Unit 00GWIC4894. RECALLING FIRM/MANUFACTURER Recalling Firm: Community Bio-Resources, Inc., Hoover, AL, by letter dated July 25, 2000. Manufacturer: Community Bio-Resources, Inc., Green Bay, WI. Firm initiated recall is complete. REASON Blood product, collected from a donor who had not completed the CJD/nvCJD increased risk questions, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Austria. _____________________________ PRODUCT Source Plasma, Recall # B-0370-3 CODE Unit 00MWIC9431 RECALLING FIRM/MANUFACTURER Recalling Firm: Community Bio-Resources, Inc., Hoover, AL, by letter dated July 31, 2000. Manufacturer: Community Bio-Resources, Inc., Menasha, WI. Firm initiated recall is complete. REASON Blood product, collected from a donor who had not completed the CJD/nvCJD increased risk questions, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Austria. _____________________________ PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-0372-3 CODE Unit number 0870914. RECALLING FIRM/MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, MN, by telephone on September 17, 2001. Firm initiated recall is complete. REASON Blood product, labeled with the incorrect expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MN. _____________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0373-3; b) Cryoprecipitated AHF, Pooled, Recall # B-0374-3; c) Recovered Plasma, Recall # B-0375-3. CODE a) and c) Unit number FQ32630; b) Pool number P27248. RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI, by telephone on March 22, 2002 and by letters on March 26, 2002. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis B surface antigen (HBsAg), but were collected from an ineligible donor based on the disclosure of a previous positive test for HBsAg, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION WI and Switzerland. _____________________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0376-3. CODE Unit number FQ31716. RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI, by telephone on July 10, 2002 and by letter dated July 25, 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 WI. _____________________________ PRODUCT Whole Blood, Leukocytes Reduced, Recall # B-0377-3 CODE Unit number FW43708. RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI, by telephone on August 19, 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 WI. _____________________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0378-3. CODE Unit number R17684. RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI, by letter dated August 29, 2002 and by telephone on August 30, 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 WI. _____________________________ PRODUCT Red Blood Cells, Recall # B-0379-3. CODE Unit number R16143. RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI, by letter dated April 11, 2002 and by telephone on April 16, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor who should have been deferred due to use of the medication Valtrex, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_____________________________ PRODUCT Source Plasma, Recall # B-0311-3. CODE Units 54DPCGHT, 54DPCMLT, 54DPBYSF. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Milwaukee, WI, by letter dated March 12, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor whose arm inspection was not documented, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION IL. _____________________________ PRODUCT Recovered Plasma, Recall # B-0353-3. CODE Units LN51836, LN50030, FQ23844 RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on August 31, 2001 and by letter dated September 4, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who should have been deferred due to use of the drug Cytotec, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION WI. _____________________________ PRODUCT Platelet, Pheresis, Leukoreduced, Irradiated. Recall # B-0354-3. CODE Units 32FP11122, 32GP19286. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Badger-Hawkeye Region, Madison, WI, by letter dated April 10, 2002. Firm initiated recall is complete. REASON Blood products that were out of controlled storage for more than thirty minutes were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MI. _____________________________ PRODUCT Source Plasma, Recall # B-0357-3. CODE Units 54DPBJZH, 54DPVSS, 54DPDWZS, 54DPCRJJ RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Milwaukee, WI, by letter dated April 12, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor whose arm inspection was not documented, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION IL. _____________________________ PRODUCT Source Plasma, Recall # B-0358-3. CODE Unit 54DPCWRQ RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Milwaukee, WI, by letter dated April 12, 2002. Firm initiated recall is complete. REASON Blood product, which was collected from a donor with an elevated body temperature, was distributed VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _____________________________ PRODUCT Platelets, Irradiated, Recall # B-0371-3. CODE Unit S09603. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter dated September 3, 2002. Firm initiated recall is complete. REASON Blood product, which was collected from a donor with an elevated body temperature, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _____________________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0380-3. CODE Unit number 21385-6285. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on January 21, 2002. Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete. REASON Blood product, collected from a donor whose body temperature was improperly recorded, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION ND.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_____________________________ PRODUCT AXIS/IRIX Gamma Camera System, controlled with Odyssey computers, operating with version 8.5 software. Recall # Z-0353-3/Z-0364-3. The systems are controlled with Odyssey computers that are connected to a Prism gantry. Some Odyssey computers operate as stand alone workstations. A Prism XPVT System, Tomography, Computed, Emission, 90KPS System. CODE Serial Numbers: 101 to 763. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Highland Heights, OH, by letter dated October 8, 2001. Firm initiated recall is ongoing. REASON A broken gantry wire may prevent the contact sensors from stopping motion of the unit. VOLUME OF PRODUCT IN COMMERCE 653 devices installed. DISTRIBUTION Nationwide and Internationally. _____________________________ PRODUCT LC+, LCV+, and LCA Angiographic X-ray Systems. Recall # Z-0365-3/Z-0381- 3. CODE All serial numbers of models 2168678, 2168678-2, 2219151, 2124824, 2168678-3, 2219150, 2107015, 2115906, 2168677, 2219152, 2219152-2. For model 2219151-2 serial numbers up to 349479BU6; for model 2219151-3 serial numbers up to 349678BU3; for model 2219150-2 serial numbers up to 349089BU3; for model 2219150-3 serial numbers up to 350083BU2; for model 2219152-3 serial numbers up to 348497BU9; and for model 2219152-4 serial numbers up to 347199BU2. RECALLING FIRM/MANUFACTURER Recalling Firm: General Electric Medical Systems, Waukesha, WI, by letter on October 28, 2002. Manufacturer: GE Medical Systems Europe, 78533 Buc Cedex, France. Firm initiated recall is ongoing. REASON The motor gearshaft for the image intensifier may break allowing the image intensifier to slide down to its end stop. VOLUME OF PRODUCT IN COMMERCE 1361 systems. DISTRIBUTION Nationwide and Internationally. _____________________________ PRODUCT BD DTX Plus Pressure Monitoring Kits and Extension Sets. Packaged as a single unit or assembled in pressure monitoring kits prior to sterilization. Recall # Z-0383-3/Z-0393-3. CODE Pressure Monitoring Kits Ref. No. Lot Number 682000 109178, 111271 682117 112035 682133 111025 686014 109020, 110026, 111030, 112028 686016 108029, 109022, 110028, 111032, 112030 686017 108030, 109023 687100 109026, 108086 687102 108087, 109027 697202 112169 687341 110517 Extension Kit 682100 112021. RECALLING FIRM/MANUFACTURER Recalling Firm: Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT, by telephone on July 8, 2002. Becton Dickinson Critical Care Systems Pte Ltd., Singapore. Firm initiated recall is complete. REASON Bond between the tubing and female or male luer fitting may fail. VOLUME OF PRODUCT IN COMMERCE 7122 pressure monitoring kits; 1450 extension sets. DISTRIBUTION Nationwide. _____________________________ PRODUCT 9 Fr. Percutaneous Sheath Introducer KitZs, catheter introducer. Recall # Z-0394-3. CODE Product Number AK-09903-S, Lot numbers: RF2088607, RF2088664, RF2088828, RF2089239, RF2089338, and RF2100307. Product Number CA-09903-LF, Lot numbers: RF2088835 and RF2089087. Product Number NL-09903-S, Lot numbers: RF2089254 and RF2099563. Product Number NM-07903, Lot numbers: RF2089116 and RF2089117. Product Number NR-09903-S, Lot numbers: RF2088648, RF2088668, RF2089256, RF2099535, and RF2099786. Product Number SM-01410, Lot number: RF2099718. Product Number SM-09813-T, Lot numbers: RF2088795, RF2089001, and RF2089206. Product Number SU-09903-S, Lot number: RF2088750. RECALLING FIRM/MANUFACTURER Arrow International, Reading, PA, by letters dated November 11, 2002. Firm initiated recall is ongoing. REASON Possibilty of leakage. VOLUME OF PRODUCT IN COMMERCE 25130 kits. DISTRIBUTION Nationwide and Internationally. _____________________________ PRODUCT Digene's Rapid Capture System (RCS) robotic microplate processor, Catalog #6000-3111. Recall # Z-0395-3. CODE S/Ns 1922, 2491, 2707, 2721, and 2730. RECALLING FIRM/MANUFACTURER Digene Corp., Gaithersburg, MD, by letters dated November 11, 2002. Firm initiated recall is ongoing. REASON IVD instrument may measure incorrect sample volume for clinical testing. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION MD, IN and OR and Japan. _____________________________ PRODUCT Holdex tube holder. Recall # Z-0396-3. CODE Item# 450261,Lot# A020208 and A050113 RECALLING FIRM/MANUFACTURER Recalling Firm: Greiner Vacuette North America, Inc., Monroe, NC, by letter dated September 11, 2002. Firm initiated recall is ongoing. REASON Holdex tube holder malfunction: the inner metal tube of device dislodged. VOLUME OF PRODUCT IN COMMERCE Lot# A020208-9800 pieces; Lot#A050113-23800 pieces. DISTRIBUTION Nationwide. _____________________________ PRODUCT Medex Vented Flow Clip Nitroglycerin Set, Pv22ml, sterile, packaged 20 units per case. Recall Z-0397-3. CODE Lot Numbers: 29A140110, 29B080171, 29B230184, 29F040045, 29G260064, 29K290194, 31K290061, and 32C260065. Catalog Number: FC7A01 RECALLING FIRM/MANUFACTURER Recalling Firm: Medex, Inc., Dublin, OH, by telephone and fax beginning October 17, 2002. Manufacturer: Medex, Inc., Hilliard, OH. Firm initiated recall is ongoing. REASON Product contains latex, however the label incorrectly states 'Latex Free'. VOLUME OF PRODUCT IN COMMERCE 304 cases (6,080 units). DISTRIBUTION IL, AL, FL, UT, NY, and CA.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_____________________________ PRODUCT Myocardial Temperature Probe, YSI 400 Series, 15mm, packaged in sterile and non-sterile pouches, 20 or 40 pouches per carton. Catalog #81-030415 and #81-031415. Recall # Z-0406-3. CODE Lots 209250, 216868, 219928, 223738, 224871, 229899, 241142, 243500, 248570, 249581, 255258, 256627, 260922, 261583, 265552, 268217, 203166, and 228438. RECALLING FIRM/MANUFACTURER Deroyal Surgical, Rose Hill, VA, by letter on September 17, 2002. Firm initiated recall is ongoing. REASON Surgical device is mislabeled with incorrect size. VOLUME OF PRODUCT IN COMMERCE 3000 units. DISTRIBUTION Nationwide.END OF ENFORCEMENT REPORT FOR JANUARY 8, 2003 ####
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