Enforcement Report - Week of January 16, 2013
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Event Detail
| Event ID | 63327 |
|---|---|
| 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 | 2012-08-17 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Tennessee; Switzerland; Florida |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Cryoprecipitated AHF, Pooled | W036811822350; | Class II | Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. | 1 | B-0275-13 |
| Fresh Frozen Plasma | 2243062; | Class II | Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. | 1 | B-0276-13 |
| Cryoprecipitated AHF | W036809216741; 2479070; | Class II | Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. | 2 | B-0277-13 |
| Platelets Pooled Leukocytes Reduced | W036810821967; W036809821585; W036809813222; 2911209; | Class II | Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. | 4 | B-0278-13 |
| Blood and Blood Products for Reprocessing | W036811262717; W036810243696; W036810039414; W036809359200; W036809216741; 2479070; | Class III | Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. | 6 | B-0279-13 |
| Red Blood Cells | W036811262717; W036810039414; W036809359200; W036809216741; 2243062; 2479070; W036810243696; | Class II | Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. | 7 | B-0280-13 |
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