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From: TSS ()
Subject: MAJOR MAD COW CJD BLOOD RECALL AL, CA, GA, IN, KY, MA, MD, MI, OH, SC, TX, and Switzerland
Date: May 18, 2005 at 6:30 pm PST
-------- Original Message -------- Subject: MAJOR MAD COW CJD BLOOD RECALL AL, CA, GA, IN, KY, MA, MD, MI, OH, SC, TX, and Switzerland Date: Wed, 18 May 2005 15:23:24 -0500 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@aegee.org ##################### Bovine Spongiform Encephalopathy #####################
RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone, facsimile, and letter between March 24, 2004, and May 21, 2004. Firm initiated recall is complete. REASON Blood products, collected from donors whose medical history screening did not include adequate questioning regarding risk factors for Creutzfeldt-Jacob disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 904 units. DISTRIBUTION AL, CA, GA, IN, KY, MA, MD, MI, OH, SC, TX, and Switzerland. RECALLS AND FIELD CORRECTIONS: Biologics - CLASS III
PRODUCT a) Red Blood Cells. Recall # B-1114-5; b) Red Blood Cells, Leukocytes Reduced. Recall # B-1115-5; c) Platelets. Recall # B-1116-5; d) Platelets, Irradiated. Recall # B-1117-5; e) Platelets, Leukocytes Reduced. Recall # B-1118-5; f) Fresh Frozen Plasma. Recall # B-1119-5; g) Recovered Plasma. Recall # B-1120-5. CODE a) Unit numbers 38KT00312 and 38KT10720 (4 split units); b) Unit numbers 38FE89461, 38FE89487, 38FE89831, 38FE89876, 38H86598, 38H86889, 38H86910, 38H86927, 38H87310, 38H87542, 38H87626, 38H87684, 38H87749, 38H87771, 38H88128, 38H88260, 38H88264, 38H88289, 38H88305, 38H88351, 38H88510, 38H88741, 38H88873, 38H88974, 38H89019, 38H89048, 38H89063, 38H89066, 38H89070, 38H89079, 38H89084, 38H89090, 38H89112, 38H89309, 38H89348, 38H89399, 38H89402, 38H89492, 38H89515, 38H89556, 38H90129, 38H90171, 38H90313, 38H90496, 38H90692, 38H90756, 38H90811, 38H90816, 38H90904, 38H90970, 38H91058, 38H91236, 38H91258, 38H91283, 38H91444, 38H91620, 38H91798, 38H91869, 38H91948, 38H91970, 38H91986, 38H92022, 38H92063, 38H92080, 38H92356, 38H92432, 38H92454, 38H92462, 38H92464, 38H92613, 38H92623, 38H92624, 38H92625, 38H92651, 38H92659, 38H92686, 38H92739, 38H92880, 38H92908, 38H92918, 38H93088, 38H93111, 38H93122, 38H93129, 38H93135, 38H93262, 38H93404, 38H93467, 38H93539, 38H93547, 38H93661, 38H93749, 38H93772, 38H93775, 38H93792, 38H93845, 38H93980, 38H94097, 38H94108, 38H94119, 38H94454, 38H94484, 38H94503, 38H94524, 38H94530, 38H94531, 38H94554, 38H94597, 38H94647, 38H94722, 38H94734, 38H94735, 38H94742, 38H94748, 38H94749, 38H94753, 38H94755, 38H94763, 38H94770, 38H94891, 38H95078, 38H95109, 38H95166, 38H95204, 38H95506, 38H95743, 38H95920, 38H95928, 38H95956, 38H95983, 38H95994, 38H95996, 38H96006, 38H96012, 38H96022, 38H96024, 38H96111, 38H96173, 38H96205, 38H96400, 38H96405, 38H96497, 38H96661, 38H96843, 38H96959, 38H97005, 38H97249, 38H97327, 38H97353, 38H97450, 38H97685, 38H97869, 38H97882, 38H97900, 38H98140, 38H98196, 38H98213, 38H98274, 38H98368, 38H98695, 38H98803, 38H99506, 38H99509, 38H99518, 38H99592, 38KT00068, 38KT00098, 38KT00106, 38KT00108, 38KT00113, 38KT00133, 38KT00141, 38KT00142, 38KT00152, 38KT00155, 38KT00164, 38KT00176, 38KT00216, 38KT00220, 38KT00226, 38KT00232, 38KT00247, 38KT00254, 38KT00590, 38KT00607, 38KT00767, 38KT00814, 38KT00824, 38KT00970, 38KT00979, 38KT00996, 38KT01018, 38KT01159, 38KT01168, 38KT01207, 38KT01531, 38KT01747, 38KT01794, 38KT01860, 38KT02218, 38KT02420, 38KT02537, 38KT02630, 38KT02750, 38KT02782, 38KT02796, 38KT02857, 38KT02859, 38KT02860, 38KT02871, 38KT02883, 38KT02930, 38KT02948, 38KT02951, 38KT02955, 38KT03156, 38KT03208, 38KT03213, 38KT03363, 38KT03367, 38KT03371, 38KT03379, 38KT03380, 38KT03385, 38KT03389, 38KT03390, 38KT03392, 38KT03421, 38KT03475, 38KT03512, 38KT03520, 38KT03584, 38KT03598, 38KT03635, 38KT03925, 38KT03942, 38KT04229, 38KT04278, 38KT04603, 38KT04763, 38KT04790, 38KT04794, 38KT05046, 38KT05077, 38KT05090, 38KT05094, 38KT05242, 38KT05255, 38KT05461, 38KT05480, 38KT05489, 38KT05564, 38KT05777, 38KT06004, 38KT06054, 38KT06127, 38KT06191, 38KT06265, 38KT06267, 38KT06272, 38KT06300, 38KT06368, 38KT06398, 38KT06421, 38KT06424, 38KT06437, 38KT06469, 38KT06493, 38KT06607, 38KT06612, 38KT06630, 38KT06822, 38KT06905, 38KT07155, 38KT07725, 38KT07751, 38KT07881, 38KT07998, 38KT08007, 38KT08046, 38KT08204, 38KT08222, 38KT08240, 38KT08242, 38KT08272, 38KT08283, 38KT08522, 38KT08558, 38KT08682, 38KT08692, 38KT08739, 38KT08800, 38KT09049, 38KT09098, 38KT09109, 38KT09227, 38KT09307, 38KT09388, 38KT09561, 38KT09722, 38KT09732, 38KT09753, 38KT09755, 38KT09757, 38KT09758, 38KT09766, 38KT09768, 38KT09773, 38KT09778, 38KT09787, 38KT09791, 38KT09798, 38KT09805, 38KT09806, 38KT09809, 38KT09816, 38KT09817, 38KT09822, 38KT09850, 38KT10027, 38KT10148, 38KT10387, 38KT10426, 38KT10447, 38KT10454, 38KT10490, 38KT10544, 38KT10552, 38KT10561, 38KT10565, 38KT10581, 38KT10591, 38KT10633, 38KT10634, 38KT10690, 38KT10748, 38KT10880, 38KT10924, 38KT10936, 38KT10964, 38KT10965, 38KT10972, 38KT10989, 38KT11005, 38KT11010, 38KT11037, 38KT11136, 38KT11437, 38KT11444, 38KT11553, 38KT11601, 38KT11787, 38KT11931, 38KT11943, 38KT11945, 38KT11966, 38KT11968, 38KT11984, 38KT12105, 38KT12115, 38KT12116, 38KT12127, 38KT12130, 38KT12132, 38KT12138, 38KT12142, 38KT12149, 38KT12339, 38KT12355, 38KT12391, 38KT12621, 38KT12810, 38KT13008, 38KT13025, 38KT13026, 38KT13104, 38KT13110, 38KT13138, 38KT13173, 38KT13306, 38KT13483, 38KT13580, 38KT13698, 38KT13710, 38KT13843, 38KT13859, 38KT13860, 38KT13862, 38KT13868, 38KT13898, 38KT13905, 38KT13923, and 38KT13980; and the following units were distributed as two split products: Unit numbers 38LC48030, 38H87730, 38KT13824, 38KT13364, 38KT12214, 38KT12215, 38KT12323, 38KT09801, 38KT08436, 38KT06358, 38KT06251, 38KT06172, 38KT06180, 38KT06000, 38KT03989, 38KT03617, 38KT03348, 38KT03350, 38KT03351, 38KT03352, 38KT01959, 38KT01257, 38KT00833, 38KT00737, 38H99159, 38H98325, 38H98149, 38H97253, 38H97095, 38H95990, 38H94800, 38H94767, 38H92548, and 38H91981; c) Unit numbers 38H88128, 38H88741, 38H89399, 38H90496, 38H90904, 38H90388, 38H93129, 38H93135, 38H93980, 38H96400, 38H97882, 38H98695, 38KT00814, 38KT00824, 38KT01018, 38KT06607, 38KT06612, 38KT06630, 38KT07155, 38KT09388, 38KT09399, 38KT09561, 38KT10027, 38KT10148, 38KT10924, 38KT10936, 38KT10964, 38KT11931, and 38KT11966; d) Unit number 38KT11968; e) Unit numbers 38H89402, 38H94891, 38H98196, and 38H98213; f) Unit numbers 38H86598, 38H87310, 38H88128, 38H88741, 38H89399, 38H89402, 38H89461, 38H90496, 38H90904, 38H93980, 38H94891, 38H96843, 38H97685, 38H97882, 38H98695, 38KT00814, 38KT00824, 38KT01747, 38KT03942, 38KT04603, 38KT04790, 38KT05480, 38KT05487, 38KT06612, 38KT06630, 38KT07155, 38KT09388, 38KT09561, 38KT09822, 38KT09850, 38KT10027, 38KT10148, 38KT10720, 38KT10924, 38KT10936, 38KT10964, 38KT11931, 38KT11943, 38KT11966, 38KT11968, 38KT12355, 38KT12621, and 38KT13173; g) Unit numbers 38FE89461, 38FE89487, 38FE89831, 38FE89876, 38H86889, 38H86910, 38H86927, 38H87542, 38H87626, 38H87684, 38H87749, 38H87771, 38H88260, 38H88264, 38H88289, 38H88305, 38H88351, 38H88510, 38H88650, 38H88873, 38H88974, 38H89048, 38H89063, 38H89066, 38H89070, 38H89079, 38H89084, 38H89090, 38H89112, 38H89309, 38H89348, 38H89492, 38H89515, 38H89556, 38H90129, 38H90171, 38H90313, 38H90692, 38H90756, 38H90811, 38H90816, 38H90970, 38H91058, 38H91236, 38H91258, 38H91283, 38H91444, 38H91620, 38H91798, 38H91869, 38H91948, 38H91970, 38H91986, 38H92022, 38H92063, 38H92080, 38H92356, 38H92432, 38H92454, 38H92462, 38H92464, 38H92613, 38H92623, 38H92624, 38H92625, 38H92651, 38H92659, 38H92686, 38H92739, 38H92880, 38H92908, 38H92918, 38H93088, 38H93111, 38H93122, 38H93129, 38H93135, 38H93262, 38H93404, 38H93467, 38H93539, 38H93547, 38H93661, 38H93749, 38H93772, 38H93775, 38H93792, 38H93845, 38H94097, 38H94108, 38H94119, 38H94454, 38H94484, 38H94503, 38H94524, 38H94530, 38H94531, 38H94554, 38H94597, 38H94647, 38H94722, 38H94732, 38H94735, 38H94742, 38H94743, 38H94748, 38H94749, 38H94753, 38H94755, 38H94763, 38H94770, 38H95078, 38H95109, 38H95166, 38H95204, 38H95506, 38H95743, 38H95920, 38H95928, 38H95956, 38H95983, 38H95994, 38H95996, 38H96006, 38H96012, 38H96022, 38H96024, 38H96111, 38H96173, 38H96205, 38H96497, 38H96661, 38H96959, 38H97005, 38H97249, 38H97327, 38H97353, 38H97450, 38H97869, 38H97900, 38H98140, 38H98196, 38H98213, 38H98274, 38H98368, 38H98803, 38H99506, 38H99509, 38H99518, 38KT00068, 38KT00098, 38KT00106, 38KT00108, 38KT00113, 38KT00133, 38KT00141, 38KT00142, 38KT00152, 38KT00155, 38KT00164, 38KT00176, 38KT00216, 38KT00220, 38KT00226, 38KT00232, 38KT00247, 38KT00254, 38KT00590, 38KT00607, 38KT00970, 38KT00979, 38KT00996, 38KT01018, 38KT01159, 38KT01168, 38KT01207, 38KT01531, 38KT01794, 38KT01860, 38KT02218, 38KT02420, 38KT02537, 38KT02630, 38KT02750, 38KT02782, 38KT02796, 38KT02857, 38KT02859, 38KT02860, 38KT02871, 38KT02883, 38KT02930, 38KT02948, 38KT02951, 38KT02955, 38KT03156, 38KT03208, 38KT03213, 38KT03363, 38KT03367, 38KT03371, 38KT03379, 38KT03380, 38KT03385, 38KT03389, 38KT03390, 38KT03392, 38KT03421, 38KT03475, 38KT03512, 38KT03520, 38KT03584, 38KT03598, 38KT03635, 38KT03925, 38KT04229, 38KT04278, 38KT04763, 38KT04794, 38KT05046, 38KT05077, 38KT05086, 38KT05090, 38KT05094, 38KT05242, 38KT05255, 38KT05461, 38KT05489, 38KT05564, 38KT05777, 38KT06004, 38KT06054, 38KT06127, 38KT06191, 38KT06265, 38KT06267, 38KT06272, 38KT06300, 38KT06368, 38KT06398, 38KT06421, 38KT06424, 38KT06437, 38KT06469, 38KT06493, 38KT06607, 38KT06822, 38KT06905, 38KT07725, 38KT07751, 38KT07881, 38KT07998, 38KT08007, 38KT08046, 38KT08204, 38KT08222, 38KT08240, 38KT08242, 38KT08272, 38KT08283, 38KT08522, 38KT08558, 38KT08682, 38KT08692, 38KT08739, 38KT08760, 38KT08800, 38KT09049, 38KT09098, 38KT09109, 38KT09227, 38KT09307, 38KT09399, 38KT09722, 38KT09732, 38KT09753, 38KT09755, 38KT09757, 38KT09758, 38KT09766, 38KT09768, 38KT09773, 38KT09778, 38KT09787, 38KT09791, 38KT09798, 38KT09805, 38KT09806, 38KT09809, 38KT09816, 38KT09817, 38KT09933, 38KT10387, 38KT10426, 38KT10447, 38KT10454, 38KT10490, 38KT10544, 38KT10552, 38KT10561, 38KT10565, 38KT10581, 38KT10591, 38KT10633, 38KT10634, 38KT10690, 38KT10748, 38KT10880, 38KT10965, 38KT10972, 38KT10989, 38KT11005, 38KT11010, 38KT11037, 38KT11136, 38KT11437, 38KT11444, 38KT11553, 38KT11555, 38KT11601, 38KT11787, 38KT11945, 38KT11984, 38KT12105, 38KT12115, 38KT12116, 38KT12127, 38KT12130, 38KT12132, 38KT12138, 38KT12142, 38KT12149, 38KT12339, 38KT12391, 38KT12810, 38KT13008, 38KT13025, 38KT13026, 38KT13104, 38KT13110, 38KT13138, 38KT13275, 38KT13301, 38KT13306, 38KT13483, 38KT13580, 38KT13698, 38KT13710, 38KT13843, 38KT13859, 38KT13860, 38KT13862, 38KT13868, 38KT13898, 38KT13905, 38KT13923, 38KT13929, 38KT13941, 38KT13980, and 38KT14160. RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone, facsimile, and letter between March 24, 2004, and May 21, 2004. Firm initiated recall is complete. REASON Blood products, collected from donors whose medical history screening did not include adequate questioning regarding risk factors for Creutzfeldt-Jacob disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 904 units. DISTRIBUTION AL, CA, GA, IN, KY, MA, MD, MI, OH, SC, TX, and Switzerland.
RECALLS AND FIELD CORRECTIONS: Biologics - CLASS III
====================================
PRODUCT Source Plasma. Recall # B-1105-5. CODE Units 6270288602, 6270287728. RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Salt Lake City, UT, by facsimile on December 31, 2002. Firm initiated recall is complete. REASON Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NC. ================================== PRODUCT Source Plasma. Recall # B-1103-5. CODE Unit numbers 01BMTA4766, 01BMTA2437, 01BMTA1228, 01BMTA0943, and 01BMTA0728. RECALLING FIRM/MANUFACTURER Recalling Firm: BioLife Plasma Services L.P. Deerfield, IL, by facsimile on August 22, 2002. Manufacturer: BioLife Plasma Services L.P., Billings, MT. Firm initiated recall is complete. REASON Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD). VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION MI. ======================================== PRODUCT a) Red Blood Cells, Leukocytes Reduced. Recall # B-1096-5; b) Platelets. Recall # B-1097-5; c) Recovered Plasma. Recall # B-1098-5. CODE a), b), and c) Unit number: 4556254. RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on February 24, 2003, and March 26, 2003, and by letter on April 15, 2003. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD). VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION OK, TX, and Switzerland. _______________________________ PRODUCT Source Plasma. Recall # B-1099-5. CODE Unit numbers 66171942 and 66169307. RECALLING FIRM/MANUFACTURER Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL, by facsimile on June 12, 2002. Manufacturer: ZLB Bioplasma, Inc., Gresham, OR. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD). VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. =============================== http://www.fda.gov/bbs/topics/enforce/2005/ENF00900.html TSS #################### https://lists.aegee.org/bse-l.html ####################
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