Enforcement Report - Week of November 28, 2012
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Event Detail
| Event ID | 63330 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Arc Blood Services, New England Region |
| City | Dedham |
| State | MA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-06 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Massachusetts; New York |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Platelets Pheresis Leukocytes Reduced Irradiated | 004GJ51699; 004GJ51699; 004GJ51699; 004GJ51700; 004GJ51700; | Class III | Blood products, with incorrectly transcribed platelet counts, were distributed. | 5 units | B-0191-13 |
| Platelets Pheresis Leukocytes Reduced | 004GJ51698; 004GJ51698; 004GJ51698; 04GZ09699; 004GZ09699; | Class III | Blood products, with incorrectly transcribed platelet counts, were distributed. | 5 units | B-0192-13 |
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