Enforcement Report - Week of August 8, 2012
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Product Detail
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Recall Number | B-1534-12 |
| Classification | Class II |
| Code Info | W043211063102; W043210098418; W043210058610; |
| Product Distributed Qty | 3 |
| Reason For Recall | Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. |
Event Detail
| Event Id | 61799 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Blood Assurance Inc |
| City | Chattanooga |
| State | TN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-03-30 |
| Initial Firm Notification of Consignee or Public | FAX |
| Distribution Pattern | Tennessee; Indiana |
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