Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | Platelets Pheresis Leukocytes Reduced Irradiated |
|---|---|
| Recall Number | B-0191-13 |
| Classification | Class III |
| Code Info | 004GJ51699; 004GJ51699; 004GJ51699; 004GJ51700; 004GJ51700; |
| Product Distributed Qty | 5 units |
| Reason For Recall | Blood products, with incorrectly transcribed platelet counts, were distributed. |
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 |
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