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U.S. Department of Health and Human Services

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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