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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 50261
Product Type Biologics
Status Terminated
Recalling Firm American Red Cross Blood Services Carolinas Region
City Winston Salem
State NC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-09-18
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern AL, GA, KY, NJ, NY, NC, PA, SC, TN

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced 12KJ48233, 12KJ48243, 12KJ48251, 12KJ48263, 12KJ48278, 12KJ48287, 12KJ48297, 12KJ48305, 12KJ48315, 12KJ48327, 12KJ48338, 12KJ48346, 12KJ48360, 12KJ48388, 12KJ48423, 12KJ48433, 12KJ48443, 12KJ48454, 12KJ48467, 12KJ48479, 12KJ48484, 12KJ48497, 12KJ48509, 12KJ48524, 12KJ48555, 12KJ48575, 12KJ48588, 12KJ48606, 12KJ48614, 12KJ48626, 12KJ48639, 12KJ48648, 12KJ48656, 12KJ48678, 12KJ48702, 12KJ48721, 12KJ48740, 12KJ48746, 12KJ48756, 12KJ48768, 12KJ48787, 12KJ48791, 12KJ48801, 12KJ48816, 12KJ48827, 12KJ48848, 12KJ48862, 12KJ48879, 12KJ48892, 12KJ48901, 12KJ48923, 12KJ48930, 12KJ48946, 12KJ48955, 12KJ48966, 12KJ48978, 12KJ48994, 12KJ49002, 12KJ49011, 12KJ49020, 12KJ49042, 12KJ49049, 12KJ49072, 12KJ49085, 12KJ49096, 12KJ49107, 12KJ49144, 12KJ49157, 12KJ49183, 12KJ49206, 12KJ49226, 12KJ49257, 12KJ49265, 12KJ49279, 12KJ49296, 12KJ49309, 12KJ49326, 12KJ49369, 12KJ49384, 12KJ49412, 12KJ49422, 12KJ49433, 12KJ49454 Class II Blood products, which did not meet the acceptable product specifications, were distributed. 83 units B-2186-12
Fresh Frozen Plasma (Apheresis) 12KJ48315 Class II Blood products, which did not meet the acceptable product specifications, were distributed. 1 B-2187-12
Platelets Pheresis Leukocytes Reduced Irradiated 12KJ48454, 12KJ48656, 12KJ48801, 12KJ48901, 12KJ48978, 12KJ49011 Class II Blood products, which did not meet the acceptable product specifications, were distributed. 6 B-2188-12
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