Enforcement Report - Week of September 26, 2012
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Product Detail
| Product Description | Source Plasma |
|---|---|
| Recall Number | B-2216-12 |
| Classification | Class II |
| Code Info | 4100390029, 4100388970, 4100388493, 4100387277, 4100386693, 4100384472, 4100382876, 4100381825, 4100380949, 4100379320, 4100378814, 4100377047, 4100376495, 4100374637, 4100374066, 4100372123, 4100371499, 4100367023, 4100366099, 4100364569, 4100363343, 4100361829, 4100360661, 4100359312, 4100357701, 4100356440, 4100355151, 4100354324, 4100352193, 4100351244, 4100349719, 4100348960, 4100347312, 4100346498, 4100344650, 4100343847, 4100342040, 4100341196, 4100339642, 4100338055, 4100337306, 4100335571, 4100334696, 4100332958, 4100332137, 4100330514, 4100329685, 4100328112, 4100327320, 4100325907, 4100323557, 4100322764, 4100321304, 4100320369, 4100319028, 4100317970, 4100316746, 4100315642, 4100313416, 4100311769, 4100310871, 4100309219, 4100307559, 4100306536, 4100304555, 4100303355, 4100302051, 4100301021, 4100298987, 4100297752, 4100296643, 4100295022, 4100294463, 4100292817, 4100291830, 4100290225 |
| Product Distributed Qty | 76 units |
| Reason For Recall | Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. |
Event Detail
| Event Id | 54208 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Csl Plasma Inc |
| City | Boca Raton |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2009-11-07 |
| Initial Firm Notification of Consignee or Public | Other |
| Distribution Pattern | IL |
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