Enforcement Report - Week of September 12, 2012
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Product Detail
| Product Description | Red Blood Cells (Apheresis) Leukocytes Reduced |
|---|---|
| Recall Number | B-2178-12 |
| Classification | Class II |
| Code Info | 003KJ21504, 003KJ21506, 003KT24309, 003KF30063, 003KJ21466, 003KT23946, 003KF30506, 003KF30523, 003KJ21504, 003KJ21299, 003KT23611, 003KT23824, 003KT21985, 003KT23919, 003KT24309, 003KF32619, 003KF32625, 003KT23915, 003KT23919, 003KF30506, 003KT23946, 003KT23952, 003KT23694, 003KT23694, 003KT23952, 003KT24164, 003KJ21506, 003KJ21299, 003KT23653, 003KT24257, 003KF30063, 003KJ21244, 003KT23610, 003KT23611, 003KT23653, 003KT24257, 003KQ40055, 003KT23830, 003KJ21466, 003KT23915, 003KF32619, 003KF32625, 003KJ21244, 003KT23610 |
| Product Distributed Qty | 44 units |
| Reason For Recall | Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. |
Event Detail
| Event Id | 44996 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | The American National Red Cross - Southern Region |
| City | Douglasville |
| State | GA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2007-09-25 |
| Initial Firm Notification of Consignee or Public | FAX |
| Distribution Pattern | AL, GA & SC |
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