Enforcement Report - Week of November 7, 2012
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Product Detail
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Recall Number | B-1997-12 |
| Classification | Class II |
| Code Info | W043211070355; W043211025900; |
| Product Distributed Qty | 2 |
| Reason For Recall | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. |
Event Detail
| Event Id | 62507 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Blood Assurance Inc |
| City | Chattanooga |
| State | TN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-18 |
| Initial Firm Notification of Consignee or Public | FAX |
| Distribution Pattern | North Carolina; Indiana |
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