Enforcement Report - Week of November 14, 2012
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Event Detail
| Event ID | 62819 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Community Blood Centers of Florida, Inc. |
| City | Lauderhill |
| State | FL |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-03-22 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Pennsylvania; Florida; New York |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Red Blood Cells (Apheresis) Leukocytes Reduced | W036811167601(Part A); W036811167601(Part B) | Class II | Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. | 2 units | B-2472-12 |
| Red Blood Cells | W036810147118; | Class II | Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. | 1 unit | B-2473-12 |
| Platelets Pooled Leukocytes Reduced | W036810810933; | Class II | Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. | 1 unit | B-2474-12 |
| Blood and Blood Products for Reprocessing | W036810147118; | Class III | Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. | 1 unit | B-2475-12 |
| Cryoprecipitated AHF | W036810147118; | Class II | Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. | 1 unit | B-2476-12 |
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