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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Product Detail

Product Description Source Plasma
Recall Number B-1529-13
Classification Class II
Code Info 08GMTF0152, 08GMTF0785, 08GMTF3115, 08GMTF3717, 08GMTF4167, 08GMTF5308, 08GMTF5477, 08GMTF6333, 08GMTF7111, 08GMTF7230, 09GMTA0072, 09GMTA0203, 09GMTA1023, 09GMTA1171, 09GMTA2062, 09GMTA2185, 09GMTA3085, 09GMTA3242, 09GMTA4213, 09GMTA4385, 09GMTA5201, 09GMTA5577, 09GMTA6122, 09GMTA6475, 09GMTA6999, 09GMTA7336, 09GMTA7847, 09GMTA8158, 09GMTA8682, 09GMTA9013, 09GMTA9522, 09GMTA9881, 09GMTB0419, 09GMTB0761, 09GMTB1325, 09GMTB1856, 09GMTB2226, 09GMTB2766, 09GMTB3149, 09GMTB3666, 09GMTB4950, 09GMTB4800, 09GMTB5225, 09GMTB5675, 09GMTB6078, 09GMTB6638, 09GMTB7066, 09GMTB7641, 09GMTB8081, 09GMTB8908, 09GMTB9368, 09GMTB9998, 09GMTC0428, 09GMTC1053, 09GMTC1481, 09GMTC2610, 09GMTD1123, 09GMTD1517, 09GMTD2197, 09GMTD2583, 09GMTD3261, 09GMTD3745, 09GMTD4477, 09GMTD4893, 09GMTD5288, 09GMTD5796, 09GMTD6366, 09GMTD6843, 09GMTD7417, 09GMTD7821, 09GMTD8493, 09GMTD8887, 09GMTD9506, 09GMTD9908, 09GMTE0871, 09GMTE1679, 09GMTC2165.
Product Distributed Qty 77 units
Reason For Recall Blood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

Event Detail

Event Id 55584
Product Type Biologics
Status Terminated
Recalling Firm BioLife Plasma Services L.P.
City Great Falls
State MT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-02-17
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern CA