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 |
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