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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Event Detail

Event ID 39991
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Salt Lake City
State UT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2005-03-17
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern CA, OK, TX, UT, and NV

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Fresh Frozen Plasma 20M38857, 20M38862, 20M38872, 20V83519, 20E34679, 20E34885, 20E34890, 20E34901, 20V83521. Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. 9 units B-0942-13
Blood and Blood Products for Reprocessing 20E34894, 20E34899, 20E34906, 20E34908, 20E34910, 20J98677, 20J98684, 20J98688, 20J9B698, 20J98700, 20J98703, 20J98710, 20J98713 , 20J98716, 20J98718, 20J98721, 20J98723, 20M38831, 20M38834, 20M38838, 20M38840, 20M38841, 20M38847, 20M38849, 20M38852, 20M38854, 20M38856, 20M38858, 20M38861, 20M38864, 20M38866, 20M38869, 20M38870, 20V83505, 20V83510, 20V83514, 20V83516, 20M40659, 20M40662, 20M40664, 20M40674. Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. 41 units B-0943-13
Red Blood Cells Leukocytes Reduced Irradiated 20M38861 Class II Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed. 1 unit B-0944-13
Red Blood Cells Leukocytes Reduced 20E34887, 20E34890, 20E34899, 20E34906, 20J98100, 20J98716, 20M38841, 20M38847, 20M38849, 20M3B852, 20M38854, 20M38872, 20VB3505, 20V83514, 20V83516, 20V83519, 20E34908, 20E34910, 20J98110, 20J98713, 20J98723, 20M38831, 20M38838, 20M38857, 20M38862, 20V83510, 20M38834, 20J98721, 20M38840, 20J98684, 20E34879, 20J98698, 20J98103, 20M38870, 20V83S21, 20J98718, 20E34885, 20E34894, 20M38856, 20M38858, 20M38866, 20J98677, 20M38864, 20M38869, 20J98688, 20E34901. Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. 46 units B-0941-13
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