Enforcement Report - Week of August 15, 2012
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Event Detail
| Event ID | 61992 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Blood Assurance Inc |
| City | Chattanooga |
| State | TN |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-01 |
| Initial Firm Notification of Consignee or Public | FAX |
| Distribution Pattern | TN, GA, NY |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Plasma Cryoprecipitated Reduced | W043210088572 | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | 1 unit | B-2009-12 |
| Red Blood Cells (Apheresis) Leukocytes Reduced | W043211094961-A; W043211094961-B; W043211044082-A; W043211025338-A; W043211044082-B; W043211025338-B | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | 6 units | B-2010-12 |
| Cryoprecipitated AHF, Pooled | W043210088572 | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | 1 unit | B-2011-12 |
| Red Blood Cells Leukocytes Reduced | V89413; V26698; W043210088572; W043210075817 | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | 4 units | B-2012-12 |
| Plasma Frozen within 24 hours (FP24) | W043210075817 | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | 1 unit | B-2013-12 |
| Blood and Blood Products for Reprocessing | V89413 | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | 1 unit | B-2014-12 |
| Fresh Frozen Plasma | V26698 | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | 1 unit | B-2015-12 |
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