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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Product Detail

Product Description Platelets Pheresis Leukocytes Reduced
Recall Number B-2614-12
Classification Class II
Code Info 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,
Product Distributed Qty 49 units
Reason For Recall Blood products, which was labeled as leukoreduced, but exceeded the White Blood Cell count limit, were distributed.

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 Telephone
Distribution Pattern MO, TN, IL, TX, AR