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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description Source Plasma
Recall Number B-2300-13
Classification Class II
Code Info 5250010874, 5250010311, 5250010319, 5250010332, 5250013674, 5250011148, 5250011158, 5250011547, 5250004906, 5250011379, 5250006860, 5250011267, 5250014217, 5250014231, 5250014243, 5250012599, 5250009582, 5250011738, 5250010341, 5250011825, 5250011786, 5250011956, 5250012050, 5250012107, 5250008037, 5250012123, 5250012160, 5250012173, 5250012239, 5250012305, 5250012307, 5250013184, 5250012247, 5250012194, 5250012196, 5250012394, 5250012351, 5250012456, 5250012471, 5250012687, 5250012522, 5250012552, 5250012556, 5250012577, 5250012518, 5250012549, 5250001560, 5250012397, 5250012692, 5250012489, 5250012497, 5250012371, 5250012357, 5250012383, 5250012446, 5250012353, 5250012683, 5250012885, 5250012701, 5250012872, 5250012859, 5250012860, 5250012762, 5250012794, 5250012808, 5250012826, 5250012731, 5250012809, 5250012944, 5250012953, 5250012942, 5250012836, 5250012838, 5250012847, 5250004109, 5250012795, 5250009400, 5250012805, 5250013040, 5250013147, 5250013148, 5250013167, 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5250005477, 5250005478, 5250005498, 5250005601, 5250005610, 5250005612, 5250005559, 5250005566, 5250005586, 5250005578, 5250005581, 5250005535, 5250005689, 5250005646, 5250005647, 5250005622, 5250005736, 5250005770, 5250005784, 5250005785, 5250005790, 5250005793, 5250005721, 5250005706, 5250005716, 5250005723, 5250005807, 5250005925, 5250005760, 5250005786, 5250005779, 5250005782, 5250005791, 5250005792, 5250005822, 5250005825, 5250005829, 5250005890, 5250005970, 5250006017, 5250005921, 5250005924, 5250005926, 5250005844, 5250005893, 5250005897, 5250006045, 5250006108, 5250006114, 5250005932, 5250006000, 5250006002, 5250005936, 5250006030, 5250006031, 5250005941, 5250005953, 5250005955, 5250005956, 5250005961, 5250005978, 5250005979, 5250006058, 5250006076, 5250006056, 5250006065, 5250006192, 5250006145, 5250006122, 5250006162, 5250006166, 5250006163, 5250006265, 5250006201, 5250006202, 5250006223, 5250006227, 5250006241, 5250006244, 5250006253, 5250006237, 5250006239, 5250006302, 5250006308, 5250006315, 5250006331, 5250006332, 5250006333, 5250006334, 5250006327, 5250006301, 5250006296, 5250006399, 5250006416, 5250006419, 5250006424, 5250006408, 5250006456, 5250006360, 5250006363, 5250006372, 5250006452, 5250006433, 5250006524, 5250006525, 5250006544, 5250006523, 5250006528, 5250006492, 5250006472, 5250006485, 5250006486, 5250006495, 5250006484, 5250006572, 5250006578, 5250006581, 5250006612, 5250006617, 5250006552, 5250006563, 5250006569, 5250006573, 5250006655, 5250006664, 5250006677, 5250006693, 5250006788, 5250006810, 5250006739, 5250006744, 5250006753, 5250006769, 5250006748, 5250006756, 5250006757, 5250006759, 5250006766, 5250006775, 5250006777, 5250006779, 5250007030, 5250007050, 5250007080, 5250006809, 5250006811, 5250006818, 5250006819, 5250005440, 5250006912, 5250006828, 5250006830, 5250006831, 5250006891, 5250006841, 5250006862, 5250006869, 5250006868, 5250006938, 5250006945, 5250006994, 5250006997, 5250007007, 5250006966, 5250006967, 5250006950, 5250007074, 5250007071, 5250007077, 5250007059, 5250007018, 5250007163, 5250007117, 5250007101, 5250007103, 5250007106, 5250007162, 5250007164, 5250007245, 5250007255, 5250007232, 5250007247, 5250007183, 5250007332, 5250007266, 5250007343, 5250007276, 5250007277, 5250007302, 5250007307, 5250007316, 5250007324, 5250007333, 5250007410, 5250007372, 5250007369, 5250007383, 5250007390, 5250007501, 5250007457, 5250007466, 5250007508, 5250007517, 5250007525, 5250007530, 5250007763, 5250007775, 5250007552, 5250007551, 5250007592, 5250007686, 5250007689, 5250007634, 5250007637, 5250007640, 5250007655, 5250007665, 5250007675, 5250007688, 5250007811, 5250007818, 5250007819
Product Distributed Qty 1,881 units
Reason For Recall Blood products, collected from donors who did not have a complete physical examination, were distributed.

Event Detail

Event Id 55402
Product Type Biologics
Status Terminated
Recalling Firm Octapharma Plasma Inc
City Des Moines
State IA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-12-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Switzerland
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