February 28, 2001 01-08
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT: Pancrelipase Capsules. Recall #D-081-1. CODE: Lot 40629 exp.12/00. MANUFACTURER: Mutual Pharmaceutical Company, Inc., Philadelphia, PA. RECALLED BY: Manufacturer, by letter on 10/10/00. Firm-initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: 3,125 bottles. REASON: Dissolution failure. ________ PRODUCT: (Rx) Hydrocortisoneand Acetic Acid OTIC Solution, USP, 1%/2%, 10 mL bottle. Recall #D-095-1. CODE: Lot No. 22864, exp. 05/01. MANUFACTURER: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL. RECALLED BY: Manufacturer, by letter on 1/23/01. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 66581 bottles. REASON: Subpotency-Hydrocortisone (12th month of stability). ________ PRODUCT: a)(RX) Isosorbide Dinitate Tablets, 10 mg, bottles of 270 tablets. Recall #D-097-1; b)(RX) Tramadol HCL tablets, 50 mg, bottles of 240 tablets. Recall #D- 098-1. CODE: a) Lot No. 12040012, Exp. Date 12-28-01; b) Lot No. 112000TM94, Exp. 11- 28-01. MANUFACTURER: REGISTERED Repacker: Veteranís Administration-Centralized Mail Order Pharmacy, Lancaster, TX. RECALLED BY: Manufacturer/Registered Repacker by telephone. Firm-initiated recall ongoing. DISTRIBUTION: S. Carolina, Virginia, and Kansas. QUANTITY: a)3,700 bottles; b) 200. REASON: Tablet mix-up. a) Furosemide 40 mg with isosorbide; Metoprolol b)Tartrate 50 mg with tramadol.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT: Oxygen, USP, liquid, in Cryogenic Home Units. Recall #D-077-1. CODE: Lot # Serial # 120400-7 C065A86 120400-6 S021185 120400-7 C034K08 120400-6 S027185 MANUFACTURER: Kern Medical Inc. dba Dasco Home Medical Equipment Company, Alliance, OH. RECALLED BY: Manufacturer, by telephone on 1/3/01. Firm-initiated recall ongoing. DISTRIBUTION: Ohio. QUANTITY: Four. REASON: Use of improper oxygen analyzer for identity testing. ________ PRODUCT: (OTC) Medi-Tussin DM Cough Suppressant/Expectorant, (Dextromethorphan HBr, USP 10 mg/Guaifenesin, USP 100 mg), in 8 Fl. Oz. Bottles. Recall #D-078-1. CODE: 9HD0020 mfr. Date 8/5/99, esp. 8/2002; 9GD0132 mfr. Date 7/15/99, exp. 7/2002; 0GD0326 mfr. Date 8/3/00, exp. 5/2003; 9GD0369 mfr. Date 8/1/99, exp. 7/2002; 9HD0021 mfr. Date 8/5,6/99, exp. 8/2002; 0GD0379 mfr. Date 8/1/00, exp. 5/2003. MANUFACTURER: Perrigo, Allegan, MI. RECALLED BY: Manufacturer, by telephone on 10/6/00 and by telephone and letter on 10/24/00. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 91,800 units. REASON: Tussin DM product mislabeled as Tussin CF on the bottles. ________ PRODUCT: (Rx) Hydrocortisone and Acetic Acid OTIC Solution, USP, 1%/2%, 10 mL bottle. Recall #D-096-1. CODE: Lot No. 22900, exp. 05/01; 22725, exp. 02/01; and 22761, exp. 02/01. MANUFACTURER: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL. RECALLED BY: Manufacturer, by letter on 1/23/01. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 66581 bottles. REASON: Degradants; out of specification results during stability testing. ________ PRODUCT: (OTC) Adult low strength enteric coated aspirin tablets, 81 mg, 120 unit bottles. Recall #D-099-1. CODE: 0032636; 0032637; 0032856; 0032858; 0033126; 0033127; 0033129; 0033203; 0033204; 0033459; 0043676; 0043691 and 0066784. MANUFACTURER: Time-Cap, Inc., Farmington, NY. RECALLED BY: Leiner Health Products, Inc., Carson, CA., by letter on 11/30/2000. Firm- initiated recall ongoing. DISTRIBUTION: MN; PA; NY; NC; MA; OH; CA; WA; CO; MD; AZ; OR; AR; FL. QUANTITY: 109,716 bottles of 120 tablets each. REASON: Superpotency.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT: Red Blood Cells. Recall #B-438-1. CODE: Units 04FS19304, 04W14252. MANUFACTURER: American Red Cross, New England Region, Dedham, MA. RECALLED BY: Manufacturer, by telephone on August 8, 2000 and by letter dated August 15, 2000. Firm-initiated recall complete. DISTRIBUTION: Massachusetts. QUANTITY: 2 units. REASON: Blood product, typed S antigen positive but shipped as S antigen negative, was distributed. ________ PRODUCT: Corneas. Recall # B-595-1. CODE: Donor ID 2000-289C, 2000-290C. MANUFACTURER: Lions Eye Bank for Long Island, Manhasset, NY RECALLED BY: Manufacturer, by telephone on November 10, 2000 and letter dated November 17, 2000. DISTRIBUTION: New York QUANTITY: Two. REASON: Corneas, from a donor who tested repeatedly reactive for the antibody to the Hepatitis B core antigen, were distributed. ________ PRODUCT: Source Plasma . Recall #B-617-1. CODE: Units MGD057, MGN956, MGN818, MGN682. MANUFACTURER: Sera-Tec Biologicals Limited Partnership, Seattle, WA. RECALLED BY: Manufacturer, by facsimile on April 28, 2000. Firm-initiated recall complete. DISTRIBUTION: North Carolina QUANTITY: Four units. REASON: Blood products, which tested negative for the hepatitis B surface antigen (HBsAg), but were collected from a donor who previously tested reactive for HBsAg, were distributed. ________ PRODUCT: Source Plasma. Recall #B-634-1. CODES: Units G-49828-079, G-49722-079, G-49473-079, G-49346-079, G-48948-079, G-48864-079, G-48632-079, G-48517-079, G-48299-079, G-48184-079, G-47971-079, G-47848-079, G-47469-079, G-47197-079, G-46839-079, G-46780-079, G-46558-079, G-46478-079, G-46190-079, G-46113-079, G-45898-079, G-45782-079, G-45524-079, G-45455-079, G-45230-079, G-45129-079, G-44907-079, G-44805-079, G-44522-079, G-44421-079, G-44132-079, G-44044-079, G-43720-079, G-43618-079, G-43365-079, G-43186-079, G-27277-079, G-27027-079, G-26854-079, G-26614-079, G-26439-079, G-25315-079, G-25085-079, G-17970-079, G-17713-079, G-17170-079, G-17044-079, G-16764-079, G-16568-079, G-15433-079, G-15323-079, G-15003-079, G-14823-079, G-14566-079, G-14378-079, G-14128-079, G-13912-079, G-13626-079, G-13434-079, G-13163-079, G-13007-079, G-12753-079, G-12547-079, G-12263-079, G-12066-079, G-11805-079, G-11610-079, G-08143-079, G-07992-079, G-07781-079, G-07421-079, G-07232-079, G-06630-079, G-06437-079, G-06250-079, G-06087-079, G-05780-079, G-05550-079, G-05369-097, G-99485-079, G-99301-079, G-98950-079, G-98751-079, G-97985-079, G-97807-079, G-97298-079, G-97048-079, G-96870-079, G-96658-079, G-99557-079, G-96368-079, G-96204-079, G-95960-079, G-95676-079, G-95490-079, G-95272-079, G-95074-079, G-94870-079, G-94706-079, G-94104-079, G-93904-079, G-93225-079, G-93007-079, G-92800-079, G-92607-079, G-92345-079, G-91910-079, N-14113-079. MANUFACTURER: Alpha Therapeutic Corp., Seattle, WA . RECALLED BY: Alpha Therapeutic Corp., Los Angeles, CA , by letters dated August 28, 2000, sent by facsimile on August 29, 2000. Firm-initiated recall complete. DISTRIBUTION: California, North Carolina, Germany and Spain. QUANTITY: 108 units. REASON: Blood products, collected from a donor with a history of having tested positive for Hepatitis B, were distributed. ________ PRODUCT: Red Blood Cells, Leukoreduced . Recall #B-669-1. CODE: Unit 01E43702 MANUFACTURER: American Red Cross Blood Services, New York - Penn Region, Rochester, NY. RECALLED BY: American Red Cross Blood Services, New York - Penn Region, West Henrietta, NY, by telephone on December 24, 1999. Firm- initiated recall complete. DISTRIBUTION: New York . QUANTITY: One unit. REASON: Blood product, which was mislabeled as CMV antibody negative, was distributed. ________ PRODUCT: Platelets, Pheresis, Leukoreduced. Recall #B-670-1. CODE: Unit 53LT67703. MANUFACTURER: American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD. RECALLED BY: Manufacturer, by telephone on September 6, 2000. Firm-initiated recall complete. DISTRIBUTION: Maryland. QUANTITY: One unit. REASON: Blood product, which was labeled as leukoreduced, but did not meet the requirements for a leukoreduced product, was distributed. ________ PRODUCT: Pulmozyme (dornase alfa) Inhalation Solution. Recall #B-671-1. CODE: Lot K9721A. Expiration date October 2001. MANUFACTURER: Genentech, Inc., South San Francisco, CA. RECALLED BY: Manufacturer, by letters dated October 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Maryland. QUANTITY: 216, 450 ampules distributed REASON: An unapproved filtration step was used to remove metal particulates from the bulk drug. _________ PRODUCTS: a)Red Blood Cells, Leukocytes Reduced. Rcall #B-672-1; b) Recovered Plasma. Recall #B-673-1. CODES: a) Units 40GE49526, 40GE49541, 40GE49549, 40GE49564, 40GE49566, 40GE49596, 40GE49615, 40LR14576, 40GE49627, 40GE49631, 40GE49660, 40GE49680, 40GE49682, 40LR14731, 40LR14764, 40LR14770, 40LR14775, 40GC51637, 40GC51647, 40GC51653, 40GC51666, 40GC51730, 40GC51747, 40GC51751. b) Units 40GE49541, 40GE49596, 40LR14576, 40GE49680, 40LR14764, 40LR14775 . MANUFACTURER: American Red Cross Blood Services, Heart of America Region, Peoria, IL. RECALLED BY: Manufacturer, by telephone on September 27, 28, & 29, 2000 and on October 10, 2000. Firm-initiated recall complete. DISTRIBUTION: Illinois and Georgia. QUANTITY: a) 24 units; b) 6 units. REASON: Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-674-1. CODES: Units 0293772, 7543601, 7543598, 8543726. MANUFACTURER: Community Blood Center of Greater Kansas City, Kansas City, MO. RECALLED BY: Manufacturer, by telephone on 11/18 & 19/98. Firm-initiated recall complete. DISTRIBUTION: Missouri and Kansas. QUANTITY: Four units. REASON: Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. ________ PRODUCT: Platelets, Pheresis. Recall #B-676-1. CODE: Units 21KP09378, 21KP09379, 21KP09380, 21KP09381. MANUFACTURER: American Red Cross, Pacific Northwest Regional Blood Services, Portland OR. RECALLED BY: Manufacturer, by telephone on September 29, 2000, and by letters dated October 13, 2000. Firm-initiated recall complete. DISTRIBUTION: Washington and Oregon. QUANTITY: Four units. REASON: Blood products, labeled with extended expiration dates, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-677-1; b) Cryoprecipitated AHF. Recall #B-678-1; c) Recovered Plasma. Recall #B-679-1. CODES: a) Unit 21GE18711; b) Unit 21GE18711; c)Unit 21GE18711. MANUFACTURER: American Red Cross, Pacific Northwest Regional Blood Services, Portland, OR. RECALLED BY: Manufacturer, by letters dated June 8, 2000. The Oregon consignee was also notified by telephone on May 30, 2000. DISTRIBUTION: California and Oregon. QUANTITY: Three units. REASON: Blood products, collected from a donor with a history of jaundice, were distributed. ________ PRODUCT: a) Red Blood Cells, Leukoreduced. Recall #B-680-1; b) Platelets. Recall #B-681-1; c) Recovered Plasma. Recall #B-682-1. CODES: a) Units 01KJ32588, 01KJ31092; b) Units 01KJ32588, 01KJ31092; c) Unit 01KJ31092. MANUFACTURER: American Red Cross Blood Services, New York - Penn Region, Rochester, NY. RECALLED BY: American Red Cross Blood Services, New York - Penn Region, West Henrietta, NY., by letters dated February 23, 2000. Firm-initiated recall complete. DISTRIBUTION: New York. QUANTITY: Five units. REASON: Blood products, collected from a donor with a history of jaundice, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-683-1; b) Platelets. b) Recall #B-684-1. CODES: a) Unit 54KF55120; b) Unit 54KF55120. MANUFACTURER: American Red Cross Blood Services, Puerto Rico Region, Rio Piedras,, PR . RECALLED BY: American Red Cross Blood Services, Puerto Rico Region, San Juan, PR, by telephone on January 17, 1997. DISTRIBUTION: Puerto Rico. QUANTITY: 2 units. REASON: Blood products, collected from a donor with a history of jaundice, were distributed. ________ PRODCTS: a) Red Blood Cells, Recall # B-685-1; b) Platelets. Recall # B-686-1; c) Fresh Frozen Plasma. Recal #B-687-1; d) Source Leukocytes for Further Manufacturer. Recall #B-688-1; e) Recovered Plasma. Recall #B-689-1. CODES: a)Units 01LY03315, 01LN02110; b)Units 01LH26327, 01LY03315; c) Units 01LH26327, 01LY03315; d)Unit 01LY03315; e)Unit 01LN02110. MANUFACTURER: American Red Cross Blood Services, New York - Penn Region, Buffalo, NY. RECALLED BY: American Red Cross Blood Services,New York - Penn Region, Rochester, NY, by letters dated November 26, 1999. Firm initiated recall complete. DISTRIBUTION: New York and New Jersey. QUANTITY: 8 units. REASON: Blood products, collected from a donor with a history of having tested positive for Hepatitis were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-691-1; b)Recovered Plasma. Recall #B- 692-1. CODE: a & b) Unit 53FP31924 MANUFACTURER: American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD. RECALLED BY: Manufacturer, by letter dated September 19, 2000. Firm-initiated recall complete. DISTRIBUTION: Maryland. QUANTITY: 2 units. REASON: Blood products, collected from a donor taking the drug Methotrexate, were distributed. ________ PRODUCT: Red Blood Cells, Irradiated. B-694-1. CODE: Unit 50X15470 MANUFACTURER: American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH. RECALLED BY: Manufacturer, by letter dated December 6, 2000. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: One unit. REASON: Red Blood Cells, missing documentation related to the irradiation process storage temperature. ________ PRODUCT: Platelet, Pheresis. Recall #B-696-1. CODE: Unit 5857791 MANUFACTURER: Central Indiana Regional Blood Center, Inc., Indianapolis, IN. RECALLED BY: Manufacturer, by telephone on November 1, 2000, and by letter on November 15, 2000. Firm-initiated recall complete. DISTRIBUTION: Indiana. QUANTITY: One unit. REASON: Blood product, which was labeled with an incorrect platelet yield, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-697-1; b) Fresh Frozen Plasma. Recall #B-698-1. CODE: a) Unit 21GL48234; b) Unit 21GL48234. MANUFACTURER: American Red Cross, Pacific Northwest Regional Blood Services, Portland, OR. RECALLED BY: Manufacturer, by letters dated October 19, 2000 and the Oregon consignee by telephone on October 6, 2000. DISTRIBUTION: Californiia and Oregon. QUANTITY: Two units. REASON: Blood products, collected from a donor with a history of having tested positive for hepatitis, were distributed. ________ PRODUCT: Recovered Plasma for Manufacturing . Recall #B-700-1. CODE: Units Y16247, Y33803 MANUFACTURER: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL. RECALLED BY: Manufacturer, by facsimile dated August 7, 2000. Firm-initiated recall complete. DISTRIBUTION: Switzerland. QUANTITY: Two units. REASON: Blood products, collected from a donor who had lived in the United Kingdom from 5/1/76 to 6/6/81, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-716-1. CODE: Unit FR23831 MANUFACTURER: Sacramento Medical Foundation Blood Center, Sacramento, CA RECALLED BY: Manufacturer, by telephone on March 17, 1999. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: One unit. REASON: Blood product, collected from a donor who had skin piercing performed within the past year, was distributed. ________ PRODUCT: a) Platelets. Recall #B-720-1; b) Source Leukocytes. Recall #B-721-1. CODE: a)Unit number 3679677; b) unit number 3660490. MANUFACTURER: Gulf Coast Regional Blood Center, Houston, TX. RECALLED BY: Manufacturer, by letter on Septemeber 13, 1999. Firm-initiated recall complete. DISTRIBUTION: Texas and Missouri. QUANTITY: Two units. REASON: Bood products, that contained unexpected antibodies, but were labeled negative for unexpected antibodies, were distributed. ________ PRODUCT: Platelets. Recall #B-732-1. CODES: unit numbers 87-15540, 38-36042, 38-36043, 30-12157, 30-12161, 30-12164, 30-12168, 30-12171, 30-12172, 30-12148, 30-12170, 30-12173, 38-36038, 62-48074, 62-48077, 62-48067, 62-48079, 63-12254, 63-12255, 63-12264, 30-12152, 87-15550, 62-48055, 34-49179, 63-12234, 87-15561, 87-15548, 87-15546, 62,48061, 62-48060, 62-48031, 34-49149, 87-15531, 87-15529, 38-36019, 38-36004, 38-36025, 38-36024, 62-48-56, 62-48051, 62-48048, 62-48043, 62-48042, 38-36022, 38-36020, 34-49156, 34-49139, 34-49142, 38-36001, 38-36007, 38-36009, 38-36012, 38-36018, 62-48008, 62-48011, 36-39833, 36-39835, 36-39839, 34-49155, 38-35997, 36-39814, 36-39816, 34-49170, 34-49174, 38-36036, 38-36039, 63-12231, 63-12233, 63-12237, 63-12240, 63-12241, 63-12242, 63-12245, 63-12246, 63-12252, 87-15552, 87-15553, 87-15556, 87-15557, 34-49162, 34-49163, 34-49164, 34-49165, 34-49166, 34-49168, 34-49169, 34-49171, 34-49172, 34-49175, 34-49176, 34-49178, 34-49180, 63-12227, 63-12228, 63-12229, 63-12232, 63-12235, 63-12243, 63-12248, 63-12249, 87-15551, 87-15555, 38-36002, 38-36003, 38-36005, 34-49158, 62-48032, 62-48033, 62-48040, 62-48046, 62-48047, 87-15521, 87-15519, 87-15526, 87-15527, 87-15517, 62-48001, 36-39822, 38-35996, 36-39813, 34-49146, 34-49144, 34-49141, 63-12266, 87-15565, 36-39865, 36-39862, 36-39861, 36-39853, 36-39851, 36-39845, 62-48088, 62-48084, 62-48081, 62-48068, 30-12153, 36-39869, 36-49194, 34-49193, 34-49190, 34-49189, 38-36045, 34-49167, 63-12218, 30-12160, 63-12239, 38-36035, 62-48058, 63-12215, 63-12222, 63-12225, 87-15538, 87-15541, 87-15543, 87-15544, 62-48038, 38-36033, 38-36032, 38-36027, 38-36026, 34-49157, 34-49154, 34-49152, 34-49151, 34-49148, 38-36021, 38-35998, 87-15520, 87-15525, 38-36000, 38-36011, 87-15530, 87-15534, 87-15536, 34-49143, 34-49135, 34-49145, 36-39840, 36-39843, 38-36006, 34-49132, 34-49134, 34-49136, 34-49137, 34-49138, 34-49130, 63-12383, 36-39838, 63-12256, and 30-12169 MANUFACTURER: Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, MI. RECALLED BY: Manufacturer, by letters on May 23, 2000, or June 16, 2000. DISTRIBUTION: Michigan. QUANTITY: 190 units. REASON: Platelets with a decreased platelet count were distributed. ________ PRODUCT: Platelets. Recall #B-733-1. CODES: (477 units), unit numbers 29GF09480, 29GF09481, 29GF09482, 29GF09484, 29GF09485, 29GF09486, 29GL57550, 29GL57555, 29GL57560, 29GL57561, 29GX48308, 29GX48311, 29GX48644, 29GX48647, 29GX48648, 29GX48669, 29GW29577, 29GW29578, 29GW29585, 29FJ38597, 29FN33006, 29FN33085, 29FN33086, 29FN33088, 29FN33090, 29FN33091, 29FN33096, 29FS81451, 29FS81522, 29FS81524, 29FS81563, 29FW37779, 29FW37781, 29FW37786, 29FW37913, 29FW37916, 29GF09478, 29GF09479, 29GW29589, 29GW29592, 29GW29594, 29GW29595, 29KJ07901, 29KJ07902, 29KJ07904, 29KJ07909, 29KJ07985, 29KJ07986, 29KJ07987, 29KM13428, 29KM13431, 29KM13432, 29KM13433, 29KX06467, 29KZ05018, 29KZ05019, 29FG80625, 29KY05256, 29FG80558, 29FN33251, 29GM79175, 29KL18534, 29FJ38452, 29KL18528, 29FG80629, 29KY05259, 29FG80563, 29FS81442, 29GP60679, 29KL18599, 29FJ38453, 29KL18529, 29FG80678, 29FW38003, 29FG80564, 29FS81443, 29GP60684, 29KL18600, 29FJ38454, 29KY05211, 29FJ38468, 29FW38019, 29FK36077, 29FS81448, 29GP60688, 29KL18601, 29FJ38455, 29KL18498, 29FJ38469, 29GF09714, 29GM79136, 29FS81449, 29GP60694, 29KL18602, 29FJ38456, 29KL18500, 29FJ38470, 29GF09718, 29GX48409, 29FS81452, 29GP60695, 29KL18604, 29FJ38457, 29KL18502, 29FJ38472, 29GF09723, 29KJ07883, 29FS81564, 29GW29575, 29KL18605, 29FJ38458, 29KL18530, 29FJ38481, 29GM79124, 29KL18381, 29FW37787, 29GW29582, 29KL18607, 29FJ38464, 29KY05215, 29FJ38483, 29KL18610, 29KL18382, 29FW37788, 29GW29587, 29KL18612, 29FJ38465, 29KY05216, 29FJ38485, 29KL18614, 29GL57567, 29FW37790, 29GW29588, 29KL18613, 29FJ38466, 29KY05222, 29FJ38486, 29FJ38420, 29GW29579, 29FW37794, 29GX48312, 29KL18615, 29FJ38467, 29KY05223, 29FJ38487, 29KJ07885, 29GX48306, 29FW37795, 29GX48313, 29KL18621, 29FJ38471, 29GL57559, 29FJ38489, 29GX48404, 29GX48307, 29FW37797, 29GX48314, 29KL18622, 29FJ38473, 29GW29598, 29FJ38490, 29GX48405, 29KM13405, 29FW37907, 29GX48316, 29KM13403, 29FJ38476, 29FS81445, 29FJ38491, 29GX48407, 29KM13406, 29FW37908, 29KJ07896, 29KM13404, 29FJ38477, 29FS81446, 29FJ38492, 29GX48620, 29KM13407, 29FW37914, 29KJ07898, 29KM13413, 29FJ38478, 29FS81447, 29FJ38494, 29GX48621, 29KM13408, 29FW37917, 29KJ07900, 29KM13417, 29FJ38480, 29GF09596, 29FJ38496, 29GX48625, 29KM13409, 29FW37919, 29KJ07903, 29KM13420, 29FJ38482, 29GL57546, 29FJ38497, 29GX48626, 29KM13410, 29FW38004, 29KJ07905, 29KM13421, 29FJ38484, 29GP60686, 29FJ38503, 29GX48632, 29KM13411, 29FW38006, 29KJ07907, 29KM13424, 29FJ38493, 29GP60687, 29FN32958, 29GX48634, 29KM13414, 29GF09483, 29KJ07910, 29KM13426, 29FJ38500, 29GP60690, 29FN32960, 29GX48641, 29KX06459, 29GF09589, 29KJ07973, 29KM13427, 29FJ38501, 29GP60691, 29FN32963, 29GX48642, 29KX06468, 29GF09592, 29KJ07974, 29KM13430, 29FJ38502, 29KJ08055, 29FN32965, 29GX48643, 29FJ38421, 29GF09597, 29KJ07976, 29KM13435, 29FJ38551, 29KL18514, 29FN33003, 29GX48645, 29FJ38422, 29GF09598, 29KJ07977, 29KM13436, 29FJ38576, 29KX06463, 29FW37791, 29GX48646, 29FJ38424, 29GF09599, 29KJ07978, 29KM13437, 29FJ38603, 29KX06465, 29FW37792, 29GX48650, 29FJ38429, 29GF09600, 29KJ07979, 29KN23513, 29FK36079, 29KJ07894, 29FW37793, 29GX48667, 29FN33089, 29GF09682, 29KJ07981, 29KN23514, 29FG80626, 29KL18609, 29FW37796, 29GX48671, 29GF09591, 29GF09684, 29KJ07982, 29KN23515, 29FG80627, 29KM13434, 29KC32047, 29GX48673, 29GF09594, 29GF09688, 29KJ08133, 29KN23522, 29FG80630, 29KC32049, 29GX48674, 29FK36081, 29GF09689, 29KJ08143, 29KN23524, 29FG80631, 29KC32050, 29KC32048, 29FK36082, 29GF09690, 29KJ08144, 29KN23527, 29FG80634, 29KC32051, 29KC32053, 29FL58928, 29GF09691, 29KJ08145, 29KX06460, 29FG80762, 29KC32052, 29KC32054, 29FL58933, 29GF09693, 29KJ08146, 29KX06461, 29FG80780, 29KC32055, 29KC32056, 29FL58937, 29GF09694, 29KJ08147, 29KX06462, 29FJ38414, 29KL18385, 29KC32058, 29FL58941, 29GF09696, 29KJ08149, 29KX06464, 29FJ38415, 29GX48406, 29KJ07881, 29FL58948, 29GF09705, 29KJ08150, 29KX06469, 29FJ38416, 29KL18379, 29KJ07884, 29FN32941, 29GF09720, 29KJ08151, 29KX06513, 29FJ38417, 29GX48408, 29KJ07886, 29FN32943, 29GF09721, 29KJ08152, 29KX06547, 29GP60692, 29KL18388, 29KJ07887, 29FN32946, 29GF09725, 29KJ08153, 29KX06562, 29GP60693, 29FJ38488, 29KJ07888, 29FN32957, 29GL57548, 29KJ08154, 29KX06569, 29KL18506, 29FG80632, 29KJ07889, 29FN32962, 29GL57549, 29KJ08155, 29KX06570, 29KL18526, 29FG80633, 29KJ07891, 29FN32964, 29GL57551, 29KJ08159, 29KX06571, 29KL18533, 29FJ38475, 29KJ07893, 29FN32966, 29GL57553, 29KJ08161, 29KY05212, 29KY05213, 29FJ38281, 29FG80559, 29FN32967, 29GL57554, 29KJ08162, 29KY05219, 29KY05217, 29FW37551, 29FG80754, 29FN33014, 29GL57556, 29KJ08163, 29KY05221, 29KY05225, 29FX58023, 29FG80756, 29FN33092, 29GL57557, 29KJ08164, 29KZ05015, 29GL57552, 29FG80677, 29FG80763, 29FN33093, 29GL57563, 29KJ08165, 29KZ05016, 29FJ38507, 29FG80764, 29FJ38419, 29FN33094, 29GM79127, 29KL18503, 29KZ05017, 29KL18383, 29FJ38505, 29FJ38432, 29FN33095, 29GM79135, 29KL18504, 29KZ05021, 29KL18386, 29FJ38506, 29FJ38463, 29FN33097, 29GM79140, 29KL18508, 29FJ38418, 29KL18387, 29FJ38610, 29FJ38560, 29FN33099, 29GM79143, 29KL18511, 29FJ38426, 29KL18389, 29FN33018, 29FJ38594, 29FN33233, 29GM79153, 29KL18517, 29FJ38427, 29FJ38423, 29FS81525, 29FJ38595, 29FN33235, 29GM79156, 29KL18518, 29FJ38428, 29GL57547, 29FW38022, 29FG80560, 29FN33238, 29GM79157, 29KL18523, 29FJ38430, 29GP60685, 29KJ07897, 29FS81561, 29FN33248, 29GM79158, 29KL18525, 29FJ38431, and 29KL18497. MANUFACTURER: The American National Red Cross,Mid-Atlantic Region, Norfolk, VA RECALLED BY: Manufacturer, by letter dated August 11, 2000. Firm-initiated recall complete. DISTRIBUTION: Virginia, North Carolina, Connecticut. QUANTITY: 477 units. REASON: Platelets with a decreased platelet count were distributed.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT: Platelet. Recall #B-594-1. CODE: Units 8174074 MANUFACTURER: LifeSource, Glenview, IL. RECALLED BY: Manufacturer, by telephone on September 11, 2000. Firm-initiated recall complete. DISTRIBUTION: Illinois. QUANTITY: One. REASON: Blood product, prepared from a Whole Blood unit that had discrepant start and end times documented, was distributed. ________ PRODUCT: Platelet Pheresis, Leukoreduced, Irradiated. Recall # B-695-1. CODE: Unit 42KW06646 MANUFACTURER: American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH. MANUFACTURER: American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH. RECALLED BY: Manufacturer, by letter dated December 6, 2000. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: One unit. REASON: Temperature documentation following irradiation was missing. ________ PRODUCT: Red Blood Cells. Recall #B-722-1. CODE: Unit number 3679677 and 3672602. MANUFACTURER: Gulf Coast Regional Blood Center, Houston, TX. RECALLED BY: Manufacturer, by letter on Septemeber 13, 1999. Firm-initiated recall complete. DISTRIBUTION: Texas and Missouri. QUANTITY: Two units. REASON: Bood products, that tested positive for unexpected antibodies, but were not labeled as positive for unexpected antibodies, were distributed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT: Cytodrape probe cover and drape. Recall #Z-0204-1. CODE: Lot number 0800101 Part number AY000293. MANUFACTURER: Cytometrics, Inc., Philadelphia, PA. RECALLED BY: Manufacturer, by telephone on 9/26 and 9/28/00. Firm-initiated recall complete. DISTRIBUTION: NC, AZ, TX, and DC. QUANTITY: 140 units. REASON: May not have received adequate dose of radiation to sterilize product. ________ PRODUCT: EScreen System, which collectively includes the eCUP, the eREADER optical imaging technology, and the eCUP data analysis software, for use in drug abuse testing. Recall #Z-205-1. CODE: All. MANUFACTURER: EScreen Inc., Overland Park, KS. RECALLED BY: Manufacturer, by letters, dated 9/12/00. Firm-initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: 300 units. REASON: Distributed without 510(k) clearance. ________ PRODUCT: Giardia lamblia Antigen Detection Microwell ELISA. Cat.# GL-35M 96 Test. Recall #Z-0206-1 CODE: Lot 9906226. Exp. Date March 2001. MANUFACTURER: Alexon-Trend, Inc., Ramsey, MN. RECALLED BY: Manufacturer, by telephone and fax on November 20,2000. Firm-initiated recall complete. DISTRIBUTION: Idaho, New Mexico and South Dakota. QUANTITY: 258 Kits. REASON: Product is not labeled as investigational use, has no 510(k) clearance. ________ PRODUCT: BD Syringe 3 ml with 21G1.5íí PrecisionGlide Needle. Recall #Z-243-1. CODE: Lot Nos. 00C3461, 00C3462, 00C3463, 00F3461, 00G3461, and 00G3462. Catalog #309577; MANUFACTURER: Becton Dickinson & Co., Franklin Lakes, NJ. RECALLED BY: Manufacturer, by letter on December 4, 2000. Firm-initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: 4,802,000 syringes. REASON: The needle shields may disengage from the needle. ________ PRODUCT: Model Eclipse TMR2000 Holmium Laser System. Recall #Z-245-1. CODE: All. MANUFACTURER: Eclipse Surgical Technologies, Sunnyvale, CA. RECALLED BY: Manufacturer, by letter on January 19, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 246 units. REASON: Lacked procedures for periodic recalibration of the laser system. ________ PRODUCT: SpF Implantable Spinal Fusion Stimulator and OsteoGen Surgically Implanted Bone Growth Stimulator a) Z-254-1 - Model SpF XL 4/CW; b) Z-255-1 - Model SpF 2T/C; c) Z-256-1 - Model SpF 2TT/CW; d) Z-257-1 - Model SpF 2T/D; e) Z-258-1 - Model SpF 2T/DW; f) Z-259-1 - Model SpF 2T/F; g) Z-260-1 - Model SpF 2T/FW; h) Z-261-1 - Model SpF 2T/GW; i) Z-262-1 - Model SpF 2T/DLW; j) Z-263-1 - Model SpF 2T/GLW; k) Z-264-1 - Model SpF 4T/C; l) Z-265-1 - Model SpF 2/C; m) Z-266-1 - Model OSTEOGEN; n) Z-267-1 - Model OSTEOGEN-M; o) Z-268-1 - Model OSTEOGEN/F; p) Z-269-1 - Model SpF XL II, 2/DW; q) Z-270-1 - Model SpF XL, 2/DM; r) Z-271-1 - Model SpF-XL IIb, 2/DW. CODES: a) Ref. #101370W; b) Ref. #101332; c) Ref. #101332W; d) Ref. # 101362; e) Ref. #101362W; f) Ref. #101382; g) Ref. #101382W; h) Ref. #101392W; i) Ref.#101363W; j) Ref. #101393W; k) Ref. #101334; l) Ref. #101304; m) Ref. #101325; n) Ref. #101325M; o) Ref. #101330; p) Ref. #101375W; q) Ref. #101385M; r) Ref. #101385W. MANUFACTURER: EBI, L.P., Parsippany, NJ. RECALLED BY: Manufacturer, by Federal Express letter on January 17, 2001. Firm- initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 715 units. REASON: The integrity of the sterile packaging may be compromised.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT: Screw Cap Centrifuge Tubes. Recall #Z-244-1. CODE: Part No. 3252. MANUFACTURER: Hardy Diagnostics, Santa Maria, CA. RECALLED BY: Manufacturer, by telephone on March 9, 2000. Firm initiated recall ongoing. DISTRIBUTION: NJ and CA. One VA account in Martinez, CA. QUANTITY: 6 cases. REASON: Tubes break during centrifugation at speed within the limit.END OF ENFORCEMENT REPORT FOR FEBRUARY 28, 2001 ####
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