Enforcement Report - Week of November 7, 2012
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Event Detail
| Event ID | 62546 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | LifeSource |
| City | Rosemont |
| State | IL |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-25 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Illinois; Pennsylvania; Switzerland |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Red Blood Cells Leukocytes Reduced Irradiated | W287911005810; | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | 1 unit | B-2459-12 |
| Platelets Pheresis | W287611005669; | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | 1 unit | B-2460-12 |
| Platelets Pheresis Leukocytes Reduced | W286912002963; W286912002963; | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | 2 units | B-2461-12 |
| Red Blood Cells | W288412002489; W288311002985; W286911003931; | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | 3 units | B-2462-12 |
| Platelets | W287911005810; W288412002489; W288311002985; W286911003931; | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | 4 units | B-2463-12 |
| Plasma Frozen within 24 hours (FP24) | W287911005810; W288412002489; W288311002985; W286911003931; | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | 4 units | B-2464-12 |
| Red Blood Cells Leukocytes Reduced | W288412002706; | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | 1 unit | B-2465-12 |
| Blood and Blood Products for Reprocessing | W288412002706; | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | 1 unit | B-2466-12 |
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