Enforcement Report - Week of August 8, 2012
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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 |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Red Blood Cells Leukocytes Reduced | W043211063102; W043210098418; W043210058610; | Class II | Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. | 3 | B-1534-12 |
| Recovered Plasma | W043211063102; W043210098418; W043210058610; | Class III | Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. | 3 | B-1535-12 |
| Platelets Pooled | W043210058610; | Class II | Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. | 1 | B-1536-12 |
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