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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Event Detail

Event ID 60141
Product Type Biologics
Status Terminated
Recalling Firm New York Blood Center, Inc.
City New York
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-10-07
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern NY, NJ, PA, CA, NC

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Plasma Cryoprecipitate Reduced W047011342870, W047011345097 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 2 units B-0524-13
Fresh Frozen Plasma W047011336452 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 1 unit B-0523-13
Red Blood Cells Leukocytes Reduced Irradiated W047011332975, W047011333909, W047011336625 (2 units), W047011338416, W047011338548, W047011342870 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 7 units B-0522-13
Cryoprecipitated AHF, Pooled W047011328328, W047011328374, W047011341225, W047011351793, W047011467903, W047011467980 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 6 units B-0521-13
Plasma Frozen within 24 hours (FP24) W047011056156, W047011336625, W047011336682, W047011338416, W047011339863, W047011342052, W047011342061 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 7 units B-0520-13
Red Blood Cells (Apheresis) Leukocytes Reduced W047011325181 (2 units), W047011333860 (2 units), W047011343932 (2 units), W047011350111 (2 units) Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 8 units B-0519-13
Platelets Pheresis Leukocytes Reduced W047011325144 (2 units), W047011341398 (2 units), W047011326254, W047011329482 (2 units), W047011348802 (2 units), W047011326489, W047011332206 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 11 units B-0518-13
Recovered Plasma W047011326288, W047011330967, W047011330978, W047011336499, W047011326528, W047011332975, W047011333350, W047011333374, W047011333379, W047011333639, W047011334415, W047011334456, W047011337580, W047011339543, W047011341943, W047011342456, W047011342822, W047011347560 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 18 units B-0517-13
Cryoprecipitated AHF W047011330978, W047011333350, W047011333374, W047011333379, W047011333639, W047011334645, W047011333639, W047011337580, W047011339543, W047011342822, W047011344906, W047011345097 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 12 units B-0516-13
Platelets Pheresis Leukocytes Reduced Irradiated W047011326254, W047011326489, W047011339265, W047011339427 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 4 units B-0515-13
Red Blood Cells Leukocytes Reduced W047011056156, W047011326288, W047011330978, W047011334076, W047011337255, W047011337381, W047011351793, W047011338532, W047011342807, W047011336499, W047011342268, W047011333963, W047011336452, W047011349758, W047011335665, W047011333350, W047011333374, W047011333379, W047011333639, W047011333978, W047011334415, W047011334422, W047011334456, W047011334645, W047011333639, W047011336682, W047011337465, W047011337580, W047011338365, W047011337942, W047011339511, W047011339543, W047011339863, W047011339875, W047011341197, W047011341225, W047011341577, W047011341654, W047011341697, W047011341943, W047011342052, W047011342061, W047011342456, W047011342822, W047011344129, W047011344906, W047011345097, W047011345107, W047011345129, W047011345528, W047011345752, W047011346513, W047011347560 (2 units), W047011347841, W047011351263, W047011326528 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 57 units B-0514-13
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