Enforcement Report - Week of February 6, 2013
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Event Detail
| Event ID | 44134 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | University of Texas Medical Branch at Galveston (The) |
| City | Galveston |
| State | TX |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2006-12-20 |
| Initial Firm Notification of Consignee or Public | FAX |
| Distribution Pattern | TX |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Red Blood Cells (Apheresis) | 4045540 | Class II | Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed. . | 1 unit | B-0437-13 |
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