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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Event Detail

Event ID 42230
Product Type Biologics
Status Terminated
Recalling Firm American Red Cross Blood Services
City Saint Louis
State MO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2006-05-05
Initial Firm Notification of
Consignee or Public
Distribution Pattern MO, TN, IL, TX, AR

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced 11LG02923; 11LG03004, 11LG02926(P1); 11LG02926 (P2); 11LG02932(P1); 11LG02932(P2), 11LG02945; 11LG02949(P1), 11LG02949(P2); 11LG02951(P1); 11LG02951(P2), 11LG02953; 11LG02957(P1); 11LG02957(P2), 11LG02953, 11LG02960(P1), 11LG02960(P2); 11LG02965; 11LG02970(P1); 11LG02970(P2), 11LG03030(P1); 11LG03030(P2); 11LG03018(P1), 11LG03018(P2), 11LG03040(P1); 11LG03040(P2); 11LG03054; 11LG03013 11LG03034(P1); 11LG03034(P2), 11LG03074, 11LG03067(P1) 11LG03024; 11LG03013; 11LG03026; 11LG03074; 11LG03048; 11LG02980; 11LG02995; 11LG02999; 11LG02978; 11LG03057; 11LG03067(P2); 11LG03046; 11LG02932; 11LG03060; 11LG03062; 11LG03004, 11LG02975, Class II Blood products, which was labeled as leukoreduced, but exceeded the White Blood Cell count limit, were distributed. 49 units B-2614-12