Enforcement Report - Week of January 30, 2013
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Product Detail
| Product Description | Platelets Pheresis Leukocytes Reduced Irradiated |
|---|---|
| Recall Number | B-0443-13 |
| Classification | Class II |
| Code Info | W115112332625J; |
| Product Distributed Qty | 1 unit |
| Reason For Recall | Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed. |
Event Detail
| Event Id | 63668 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | LifeSouth Community Blood Centers, Inc. |
| City | Gainesville |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-19 |
| Initial Firm Notification of Consignee or Public | FAX |
| Distribution Pattern | Alabama |
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