Enforcement Report - Week of December 12, 2012
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Product Detail
| Product Description | Source Plasma |
|---|---|
| Recall Number | B-0069-13 |
| Classification | Class II |
| Code Info | 08OUTB4879, 08OUTB2635, 08OUTB1306, 08OUTA8922, 08OUTA7100, 08OUTA6681, 08OUTA5922, 08OUTA5562, 08OUTA4418, 08OUTA4386, 08OUTA3642, 08OUTA3242, 08OUTA2979, 08OUTA2077, 08OUTA0915, 07OUTF4985, 07OUTF4353, 07OUTF3686, 07OUTA4758, 07OUTA5615, 07OUTB0037, 07OUTB0803, 07OUTB1486, 07OUTB2556, 07OUTB3213, 07OUTB3834, 07OUTB6136, 07OUTB6376, 07OUTB7237, 07OUTB9597, 07OUTC0475, 07OUTC1012, 07OUTC2225, 07OUTC2842, 07OUTC4143, 07OUTC4456, 07OUTC5199, 07OUTC6632, 07OUTC8560, 07OUTD1005, 07OUTD3596, 07OUTD5143, 07OUTD5720, 07OUTD6487, 07OUTD7609, 07OUTD9191, 07OUTE0341, 07OUTE3864, 07OUTE8341, 07OUTE9470, 07OUTF2162, 07OUTF3686, 07OUTD4266, 07OUTC9724, 07OUTD0460, 07OUTD2498, 07OUTD8237, 07OUTE0989, 07OUTE1522, 07OUTE6623, 07OUTE7686, 07OUTF0829, 07OUTF1519, 07OUTF4353, 07OUTF4985, 07OUTD5720, 07OUTD6487, 07OUTD7609, 07OUTD9191, 07OUTE0341, 07OUTE3864, 07OUTE8341, 07OUTE9470, 07OUTF2162, 07OUTF3686, 07OUTS0487 08OUTA2979, 08OUTB2635, 08OUTA2077, 08OUTA4386, 08OUTB6603, 08OUTB7200, 08OUTA0915, 08OUTB5655, 07OUTS0551, 07OUTS0998, 07OUTS0940, 07OUTS0991, 07OUTS1070, 07OUTS1118, 07OUTS1162, 07OUTS1334, 07OUTS1350, 07OUTS1415, 07OUTS1589, 07OUTS1654, 07OUTS1692, 07OUTS1778, 07OUTS1828, 07OUTS1923, 07OUTS1946, 07OUTS1999, 07OUTS2108, 07OUTS2247, 07OUTS2428, 07OUTS2617, 07OUTS0273, 07OUTS0551 |
| Product Distributed Qty | 108 |
| Reason For Recall | Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. |
Event Detail
| Event Id | 48843 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | BioLife Plasma Services L.P. |
| City | Ogden |
| State | UT | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2008-06-09 |
| Initial Firm Notification of Consignee or Public | FAX |
| Distribution Pattern | CA |
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