Enforcement Report - Week of October 3, 2012
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Event Detail
| Event ID | 46539 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Community Blood Bank of Lancaster County Medical Society |
| City | Lincoln |
| State | NE |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2007-12-07 |
| Initial Firm Notification of Consignee or Public | FAX |
| Distribution Pattern | NE; OH; TN; MO; Austria |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Blood and Blood Products for Reprocessing | 6067919;6070284;6075510 | Class III | Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. | 3 units | B-2060-12 |
| Red Blood Cells Leukocytes Reduced | 6066046;6070284;6073935;6075510 | Class II | Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. | 4 units | B-2061-12 |
| Cryoprecipitated AHF | 6066046 | Class II | Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. | 1 unit | B-2062-12 |
| Plasma Cryoprecipitated Reduced | 6066046 | Class II | Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. | 1 unit | B-2063-12 |
| Fresh Frozen Plasma | 6073935 | Class II | Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. | 1 unit | B-2064-12 |
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