Enforcement Report - Week of September 19, 2012
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Product Detail
| Product Description | Red Blood Cells (Apheresis) Leukocytes Reduced |
|---|---|
| Recall Number | B-1492-12 |
| Classification | Class III |
| Code Info | W0415120158940 |
| Product Distributed Qty | 1 unit |
| Reason For Recall | Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. |
Event Detail
| Event Id | 62026 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Blood Systems, Inc. dba United Blood Services |
| City | Lubbock |
| State | TX | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-18 |
| Initial Firm Notification of Consignee or Public | FAX |
| Distribution Pattern | TX |
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