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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Event Detail

Event ID 44996
Product Type Biologics
Status Terminated
Recalling Firm The American National Red Cross - Southern Region
City Douglasville
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-09-25
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern AL, GA & SC

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells (Apheresis) Leukocytes Reduced 003KJ21504, 003KJ21506, 003KT24309, 003KF30063, 003KJ21466, 003KT23946, 003KF30506, 003KF30523, 003KJ21504, 003KJ21299, 003KT23611, 003KT23824, 003KT21985, 003KT23919, 003KT24309, 003KF32619, 003KF32625, 003KT23915, 003KT23919, 003KF30506, 003KT23946, 003KT23952, 003KT23694, 003KT23694, 003KT23952, 003KT24164, 003KJ21506, 003KJ21299, 003KT23653, 003KT24257, 003KF30063, 003KJ21244, 003KT23610, 003KT23611, 003KT23653, 003KT24257, 003KQ40055, 003KT23830, 003KJ21466, 003KT23915, 003KF32619, 003KF32625, 003KJ21244, 003KT23610 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 44 units B-2178-12
Fresh Frozen Plasma 003KT21845, 003KT22093, 003KT21844, 003KT21846, 003KP40859, 003KT22248, 003KF32591, 003KT23823, 003KF30043, 003KJ21806, 003KJ21790, 003KP40848, 003KP40870, 003KF30502, 003KJ21312, 003KJ21314, 003KT23926, 003KJ21345, 003KJ21727, 003KJ21729, 003KT21947, 003KT21814, 003KP40853, 003KJ21368, 003KJ21372, 003KT23988, 003KT24059, 003KT24152, 003KT24159, 003KP47200, 003KT24275, 003KT24288, 003KT24318, 003KJ21821, 003KP40829, 003KP40832, 003KP40858, 003KT24112, 003KT21927, 003KT23932, 003KT23928, 003KT23941, 003KT24281, 003KT21808, 003KT21831, 003KT21931, 003KP40866, 003KP40872, 003KF30085, 003KT22261, 003KT22262, 003KF32600, 003KQ40068, 003KT23894, 003KT23897, 003KT23940, 003KT23945, 003KP46744, 003KP46750, 003KJ21375, 003KJ21395, 003KJ21435, 003KQ40330, 003KT24018, 003KT24021, 003KT24114, 003KT24116, 003KT24145, 003KT24269, 003KT24286, 003KT24302, 003KF30497, 003KF30500, 003KF30530, 003KT22122, 003KT22128, 003KT22135, 003KT24171, 003KT24247, 003KT21200, 003KT21201, 003KT21204, 003KT24291, 003KT21821, 003KT21843, 003KP40837, 003KP40862, 003KP40871, 003KF3000, 003KF30139, 003KT22110, 003KF30504, 003KT22132, 003KT22133, 003KT22136, 003KT23831, 003KJ21351, 003KJ21392, 003KJ21427, 003KJ21436, 003KT23991, 003KT24051, 003KJ21699, 003KT24283, 003KT24301, 003KT24311, 003KT24315, 003KJ21804, 003KJ21850, 003KT21836, 003KT21842, 003KP40840, 003KT21981, 003KF30007, 003KF30073, 003KF30197, 003KT22131, 003KT22134, 003KT24118, 003KT21938, 003KJ21782, 003KT21849, 003KQ40059, 003KT21834, 003KQ40067, 003KJ21616, 003KJ21859, 003KJ21861, 003KT24014, 003KT21820, 003KT21824, 003KT21825, 003KT21827, 003KT21830, 003KT21837, 003KT21840, 003KP40838, 003KP40839, 003KF30037, 003KT21839, 003KF30040, 003KF30048, 003KF30056, 003KT22079, 003KT22082, 003KF30517, 003KT22259, 003KQ40066, 003KT23929, 003KT23933, 003KT23949, 003KT23954, 003KT23955, 003KJ21361, 003KJ21362, 003KJ21394, 003KJ21397, 003KT23970, 003KT24007, 003KT24199, 003KJ21774, 003KJ21784, 003KJ21785, 003KT24274, 003KT24330, 003KJ21839, 003KJ21852, 003KF30512, 003KT24327, 003KP40863, 003KF30057, 003KT22080, 003KT22081, 003KT22084, 003KT22255, 003KJ21305, 003KT24015, 003KT24300, 003KT22292, 003KT23636, 003KT23757, 003KT24011, 003KT22083, 003KT21810, 003KT24148, 003KJ21843, 003KJ21846, 003KT21203, 003KT21209, 003KT21813, 003KP40857, 003KF30097, 003KT22111, 003KF30507, 003KF30515, 003KT22119, 003KT23925, 003KJ21428, 003KT24077, 003KT24113, 003KJ21717, 003KJ21730, 003KP47192, 003KP47196, 003KP47197, 003KP47199, 003KJ21796, 003KJ21880, 003KT24047, 003KT21206, 003KT21848, 003KP40827, 003KP40835, 003KP40852, 003KP40855, 003KF30011, 003KF30016, 003KF30025, 003KF30091, 003KF32594, 003KF32604, 003KF32615, 003KQ40062, 003KT23836, 003KT24047, 003KJ21863, 003KT21816, 003KT21818, 003KT23805, 003KT23819, 003KJ21348, 003KT24246, 003KT23811, 003KT24312, 003KJ21313, 003KT21972, 003KT22093, 003KJ21449, 003KT21940, 003KT21970, 003KJ21308, 003KJ21697, 003KP46746, 003KT23636, 003KT23816, 003KT24251, 003KF30027, 003KF30090, 003KT21847, 003KP40868, 003KF30046, 003KT22123, 003KF30513, 003KT24255, 003KP47191, 003KP47193, 003KF30020, 003KT22197, 003KT22239, 003KT24057, 003KT24065, 003KP47188, 003KP47203, 003KT22253, 003KT24074, 003KT24074, 003KT22243, 003KT24063, 003KT23838, 003KT24048, 003KT24266, 003KJ21878, 003KF30104, 003KJ21315, 003KT22249 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 275 units B-2177-12
Blood and Blood Products for Reprocessing 003KJ21463, 003KT23606, 993KF30121, 003KF30164, 003KF30166, 003KF30180, 003KF30509, 003KF32606, 003KF32616, 003KJ21212, 003KJ21216, 003KJ21223, 003KJ21224, 003KJ21229, 003KJ21238, 003KJ21241, 003KJ21245, 003KJ21246, 003KJ21247, 003KJ21251, 003KJ21290, 003KJ21292, 003KJ21293, 003KJ21294, 003KJ21295, 003KJ21304, 003KJ21306, 003KJ21310, 003KJ21311, 003KJ21333, 003KJ21335, 003KJ21338, 003KJ21340, 003KJ21342, 003KJ21346, 003KJ21353, 003KJ21359, 003KJ21364, 003KJ21365, 003KJ21371, 003KJ21376, 003KJ21377, 003KJ21391, 003KJ21396, 003KJ21398, 003KJ21401, 003KJ21402, 003KJ21403, 003KJ21424, 003KJ21426, 003KJ21430, 003KJ21432, 003KJ21437, 003KJ21439, 003KJ21446, 003KJ21448, 003KJ21450, 003KJ21452, 003KJ21454, 003KJ21457, 003KJ21459, 003KJ21461, 003KJ21465, 003KJ21467, 003KJ21486, 003KJ21488, 003KJ21490, 003KJ21492, 003KJ21494, 003KJ21496, 003KJ21498, 003KJ21499, 003KJ21500, 003KJ21502, 003KJ21503, 003KJ21507, 003KJ21508, 003KJ21509, 003KJ21575, 003KJ21578, 003KJ21579, 003KJ21580, 003KJ21581, 003KJ21583, 003KJ21584, 003KJ21585, 003KJ21586, 003KJ21588, 003KJ21686, 003KJ21691, 003KJ21693, 003KJ21695, 003KJ21696, 003KJ21725, 003KJ21811, 003KJ21814, 003KJ21816, 003KJ21818, 003KJ21827, 003KJ21830, 003KJ21834, 003KJ21848, 003KP40831, 003KP40836, 003KP40850, 003KP40860, 003KP40861, 003KP40865, 003KP46747, 003KP46748, 003KP47186, 003KQ40052, 003KQ40054, 003KQ40057, 003KQ40058, 003KQ40061, 003KQ40065, 003KQ40318, 003KQ40324, 003KQ40325, 003KQ40327, 003KT21207, 003KT21212, 003KT21213, 003KT21216, 003KT21219, 003KT21229, 003KT21231, 003KT21233, 003KT21234, 003KT21235, 003KT21236, 003KT21237, 003KT21747, 003KT21748, 003KT21752, 003KT21753, 003KT21755, 003KT21757, 003KT21759, 003KT21763, 003KT21764, 003KT21766, 003KT21768, 003KT21772, 003KT21773, 003KT21774, 003KT21777, 003KT21778, 003KT21781, 003KT21782, 003KT21812, 003KT21841, 003KT21850, 003KT21971, 003KT21973, 003KT21975, 003KT21976, 003KT21977, 003KT21978, 003KT21979, 003KT21986, 003KT22042, 003KT22046, 003KT22048, 003KT22049, 003KT22051, 003KT22052, 003KT 22054, 003KT22056, 003KT22057, 003KT22060, 003KT22061, 003KT22062, 003KT22063, 003KT22066, 003KT22069, 003KT22070, 003KT22072, 003KT22105, 003KT22106, 003KT22107, 003KT22108, 003KT22109, 003KT22117, 003KT22137, 003KT22183, 003KT22184, 003KT22186, 003KT22187, 003KT22189, 003KT22192, 003KT22194, 003KT22196, 003KT22200, 003KT22203, 003KT22206, 003KT22208, 003KT22209, 003KT22210, 003KT22240, 003KT22245, 003KT22252, 003KT22267, 003KT22268, 003KT22269, 003KT22272, 003KT22274, 003KT22278, 003KT22280, 003KT22287, 003KT22291, 003KT22292, 003KT22293, 003KT22296, 003KT22298, 003KT22299, 003KT22301, 003KT22304, 003KT22305, 003KT22306, 003KT22307, 003KT22310, 003KT23602, 003KT23603, 003KT23607, 003KT23608, 003KT23613, 003KT23614, 003KT23616, 003KT23617, 003KT23618, 003KT23619, 003KT23624, 003KT23625, 003KT23626, 003KT23627, 003KT23629, 003KT23631, 003KT23633, 003KT23635, 003KT23639, 003KT23642, 003KT23643, 003KT23647, 003KT23648, 003KT23651, 003KT23654, 003KT23660, 003KT23663, 003KT23665, 003KT23678, 003KT23679, 003KT23680, 003KT23681, 003KT23757, 003KT23759, 003KT23808, 003KT23812, 003KT23814, 003KT23821, 003KT23834, 003KT23839, 003KT23916, 003KT23918, 003KT23921, 003KT23922, 003KT23935, 003KT23943, 003KT23950, 003KT23957, 003KT23958, 003KT23960, 003KT23962, 003KT23964, 003KT23965, 003KT23972, 003KT23975, 003KT23985, 003KT23990, 003KT23996, 003KT24009, 003KT24019, 003KT24023, 003KT24038, 003KT24039, 003KT24040, 003KT24045, 003KT24049, 003KT24055, 003KT24066, 003KT24068, 003KT24103, 003KT24104, 003KT24105, 003KT24108, 003KT24144, 003KT24147, 003KT24149, 003KT24154, 003KT24157, 003KT24161, 003KT24162, 003KT64164, 003KT24166, 003KT24168, 003KT24169, 003KT24262, 003KT24264, 003KT24271, 003KT24293, 003KT24305, 003KT24306, 003KT24314, 003S42153, 003S42155, 003S42156, 003S42158, 003V47015, 003V47016, 003V47019, 003V47022, 003V47023, 003V47025, 003V47026, 003V47027, 003V47028, 003V47033, 003V47034, 003V47035, 003V47039, 003V47040, 003V47041, 003V47045, 003V47046, 003V47152, 003V47153, 003V47155, 003V47158, 003V47159, 003V47160, 003V47161, 003V47162, 003KJ21356, 003KJ21393, 003KT21218, 003KT21770, 003KT21983, 003KT23656, 003KT21930, 003KT21934, 003KT21943, 003KT21945, 003KT21949, 003KT22044 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 355 units B-2182-12
Red Blood Cells Leukocytes Reduced 003KJ21586, 003KT23643, 003V47039, 003KP40835, 003KT21821, 003KT22063, 003KT22054, 003KT21840, 003KT23957, 003KT23960, 003KT23964, 003KT23972, 003V47019, 003V47022, 003KT24291, 003V47045, 003KT23619, 003KF30512, 003KF30513, 003KT22239, 003KT22255, 003KT24053, 003KT21818, 003KF30034, 003KF30166, 003KJ21302, 003KJ21397, 003KJ21402, 003KJ21403, 003KJ21450, 003KJ21454, 003KJ21467, 003KJ21579, 003KJ21580, 003KT21781, 003KT21981, 003KT22240, 003KT23608, 003KT23617, 003KT23759, 003KT23929, 003KT23941, 003KT23949, 003KT24011, 003KT24265, 003V47015, 003V47034, 003V47046, 003KT24328, 003KP47196, 003KJ21696, 003KJ21434, 003KT21212, 003KT21233, 003KT23633, 003KT23651, 003KT23658, 003KT23990, 003KT24315, 003V47161, 003KF30139, 003KF30502, 003KF30507, 003KF30509, 003KF30515, 003KJ21353, 003KJ21811, 003KT21810, 003KT21825, 003KT21849, 003KT21927, 003KT21933, 003KT21986, 003KT22044, 003KT22046, 003KT22048, 003KT22070, 003KT22131, 003KT22134, 003KT22137, 003KT22200, 003KT22206, 003KT22262, 003KT23625, 003KT23681, 003KT24068, 003KT24108, 003KT24306, 003KJ21490, 003KJ21811, 003KT22194, 003KT22093, 003KJ21428, 003KJ21461, 003KT22208, 003KT23814, 003KT23940, 003KT23950, 003KJ21338, 003KT23916, 003KJ21340, 003KJ21436, 003KJ21796, 003KP47186, 003KT21236, 003KT21812, 003KT21813, 003KT21814, 003KT21847, 003KT22049, 003KT22122, 003KT22128, 003KT22129, 003KT22132, 003KT22135, 003KT22253, 003KT23626, 003KT23663, 003KT23830, 003KT24154, 003KJ21936, 003KT22042, 003KT22243, 003KJ21393, 003KF30197, 003KJ21730, 003KP40836, 003KT21945, 003KT23894, 003KT21200, 003KJ21804, 003KJ21346, 003KJ21782, 003KJ21784, 003KT22305, 003KT24057, 003KJ21503, 003KJ21348, 003KF30000, 003KF32591, 003KJ21251, 003KJ21312, 003KJ21584, 003KJ21695, 003KT22081, 003KF30132, 003KT21757, 003KT21934, 003KT21938, 003KT21940, 003KT21970, 003KT22061, 003KJ21814, 003KP47197, 003KJ21313, 003KT23624, 003KT24157, 003KP47203, 003KJ21777, 003KT24271, 003KJ21356, 003KF30057, 003KF30073, 003KF32615, 003KJ21245, 003KJ21304, 003KJ21308, 003KJ21396, 003KJ21439, 003KJ21361, 003KJ21508, 003KJ21585, 003KP40871, 003KT21830, 003KT21930, 003KT21943, 003KT21947, 003KT22066, 003KT22186, 003KT22187, 003KT22192, 003KT23616, 003KT23648, 003KT23654, 003KT23918, 003KT23943, 003V47028, 003V47158, 003KF30517, 003KT21748, 003KT21750, 003KT21760, 003KT21770, 003KT21774, 003KT22062, 003KT22119, 003KT22051, 003KT24168, 003KT24249, 003KT24333, 003KJ21818, 003KJ21830, 003KJ21878, 003KF32594, 003KT21834, 003KT21976, 003KT22307, 003KJ21500, 003KF30097, 003KJ21463, 003KJ21502, 003KJ21583, 003KP46747, 003KT21978, 003KT22069, 003KT22248, 003KT22298, 003KT23991, 003KJ21342, 003KJ21359, 003KP40829, 003KF30114, 003KJ21290, 003KJ21293, 003KJ21426, 003KP46746, 003KT21844, 003KT21985, 003KT22108, 003KT22252, 003KT22280, 003KT22287, 003KT23661, 003KT23680, 003KT23819, 003KT23824, 003KT23826, 003KT23958, 003KT23962, 003KT24019, 003KT24066, 003KT24114, 003KT24149, 003KJ21725, 003KP47188, 003KP47192, 003KT24334, 003KJ21362, 003KT24286, 003KT24308, 003KT22057, 003KT22083, 003KT22299, 003KT22306, 003KT22308, 003KT22310, 003KT23994, 003KF30010, 003KF30016, 003KJ21575, 003KT23613, 003KT23642, 003KT24049, 003KT24074, 003KT24246, 003KJ21848, 003KF30504, 003KJ21859, 003KJ21398, 003KQ40057, 003KQ40066, 003KT21209, 003KT24145, 003KT24148, 003KT24162, 003V47041, 003V47155, 003KT21816, 003KT24023, 003KJ21839, 003KJ21307, 003KJ21399, 003KJ21247, 003KF30530, 003KQ40054, 003KQ40065, 003KQ40068, 003KT22210, 003KT24318, 003KT21234, 003KT24040, 003KT24063, 003V47026, 003V47040, 003KJ21427, 003KJ21616, 003KP40866, 003KP46748, 003KQ40055, 003KT21231, 003KT21838, 003KT24302, 003KT22079, 003KT24301, 003KJ21850, 003KJ21827, 003KJ21351, 003KT21842, 003KT21846, 003KT21972, 003KT22105, 003KT22106, 003KT22110, 003KT22111, 003V47025, 003KT24021, 003KF32604, 003KP40868, 003KF30164, 003KJ21314, 003KJ21492, 003KJ21779, 003KJ21846, 003KT24255, 003KJ21699, 003KP40838, 003KT21931, 003KT21949, 003KT22123, 003KT22136, 003KT23812, 003KF30104, 003KJ21238, 003KJ21377, 003KT22082, 003KT22184, 003KP40837, 003KT21843, 003KT21848, 003KJ21775, 003KJ21780, 003KJ21790, 003KJ21845, 003KJ21855, 003KF30091, 003KF30121, 003KJ21315, 003KP40860, 003KP40862, 003KT21207, 003KT21837, 003KT23602, 003KJ21391, 003KT22183, 003KT22189, 003KT22209, 003KT23635, 003KJ21843, 003KF32618, 003KT22060, 003KT24147, 003KJ21364, 003KT21216, 003V47159, 003V47162, 003KJ21686, 003KY24153, 003KT24274, 003KJ21857, 003KT22268, 003KT22278, 003KT24105, 003KT24264, 003KT24262, 003KT24266, 003KF30011, 003KF30037, 003KF30046, 003KJ21394, 003KJ21433, 003KJ21452, 003KJ21459, 003KJ21465, 003KJ21577, 003KP40839, 003KP40848, 003KP40863, 003KP46744, 003KT21206, 003KT21768, 003KT21975, 003KT21977, 003KT22117, 003KT22203, 003KT22259, 003KT22269, 003KT23678, 003KT23679, 003KT23831, 003KT23954, 003KT23955, 003KT23970, 003KT23975, 003KT24262, 003KT24266, 003KJ21216, 003KJ21333, 003KJ21335, 003KJ21345, 003KJ21372, 003KJ21449, 003KT21203, 003KT22272, 003KT23607, 003KT23627, 003KT23629, 003KT23631, 003KT23838, 003KT24009, 003KJ21727, 003KJ21729, 003KT24169, 003KP47191, 003KP47200, 003KT24161, 003KJ21368, 003KJ21834, 003KT24018, 003KT24152, 003KT24275, 003KJ21837, 003KF30007, 003KF30056, 003KF30082, 003KF30497, 003KJ21499, 003KJ21507, 003KJ21581, 003KJ21785, 003KT24247, 003KF30048, 003KT21755, 003KT21766, 003KT21973, 003KT21979, 003KT23614, 003KT23656, 003KT24059, 003S42155, 003KP40827, 003KP40861, 003KQ40330, 003KT23897, 003V47160, 003KT21747, 003KT21753, 003KJ21371, 003KP40870, 003V47035, 003KJ21880, 003KF30085, 003KF30027, 003KF30040, 003KF30090, 003KJ21305, 003KJ21424, 003KP40831, 003KP40853, 003KT21235, 003KT22267, 003KT22296, 003KT22303, 003KT23811, 003KT23836, 003KT23925, 003KT23945, 003KP40855, 003KT21759, 003KT22056, 003KT22133, 003KT23665, 003KJ21821, 003KT23665, 003KT24312, 003KF30043, 003KF30500, 003KQ40324, 003KT21831, 003KT22080, 003KT22084, 003KT22107, 003KT23618, 003KT23921, 003KT23985, 003KT23996, 003KT24077, 003KT24312, 003V47023, 003KF32616, 003KT21777, 003KT21778, 003KT23647, 003KT23660, 003KT23823, 003KT23988, 003KJ21806, 003KF30020, 003KT21850, 003KJ21392, 003KJ21614, 003KT21820, 003KT21827, 003KT21836, 003KP40832, 003KT22293, 003KT24171, 003KP47199, 003KT24281, 003KJ21306, 003KJ21437, 003KJ21486, 003KJ21588, 003KQ40052, 003KQ40058, 003KQ40059, 003KT22274, 003KT23606, 003KT24039, 003KT24045, 003KT24065, 003V47027, 003KP46750, 003KP48057, 003KT21218, 003KT21219, 003KT22052, 003KT22249, 003KT21204, 003V47153, 003KF32610, 003KT21841, 003KT23639, 003V47152, 003KJ21717, 003KT24288, 003KJ21435, 003KJ21697, 003KT23603, 003V47033, 003KT24159, 003KQ40067, 003KF30060, 003KJ21292, 003KJ21295, 003KJ21430, 003KJ21432, 003KJ21448, 003KJ21457, 003KP40872, 003KT21201, 003KT21213, 003KT22196, 003KT23928, 003KT23932, 003KT23933, 003KT22291, 003KT22304, 003KJ21365, 003KT24269, 003KJ21223, 003KT21773, 003KJ21509, 003KP40840, 003KP40852, 003KP40858, 003KP40859, 003KT22301, 003KT24327, 003KT24330, 003KT21808, 003KJ21310, 003KT22072, 003KJ21446, 003KT24118, 003KT24144, 003KF32600, 003KF32606, 003KJ21496, 003KJ21498, 003KQ40061, 003KQ40062, 003KT21752, 003KT21845, 003KT23922, 003KT21824, 003KT22109, 003KT21237, 003KJ21863, 003S42153, 003S42156, 003KJ21375, 003KJ21376, 003KJ21395, 003KJ21401 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 612 units B-2181-12
Red Blood Cells Leukocytes Reduced Washed 003KJ21693 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. One unit B-2180-12
Red Blood Cells Leukocytes Reduced Irradiated 003KT21971, 003KF30025, 003KT21764, 003KT34048, 003KT24315, 003KQ40318, 003KQ40327, 003KT22197, 003KT24014, 003KT24104, 003KJ21494, 003KT24311, 003KJ21691, 003KT24305, 003KJ21229, 003KJ21246, 003KT24051, 003KJ21774, 003KT24314, 003KT24320, 003KJ21224, 03KQ40325, 003KT23980, 003KT24038, 003S42158, 003KT21983, 003KT24047, 003KT24103, 003KJ21294, 003KT21229, 003KT23982, 003KJ21578, 003KT24199, 003KT23808, 003KT23816, 003KT23821, 003KT23926 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 37 units B-2179-12
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