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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Event Detail

Event ID 49278
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City West Henrietta
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-06-18
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern NY & PA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells 01KG99432, 01KG99431, 01KG99434, 01KG99435, 01KG99438, 01KG99460, 01KG99447, 01KG99445, 01KG99458, 01KG99453, 01KG99457, 01KG99451, 01KG99441, 01KG99456, 01KG99433, 01KG99436, 01GE72762, 01GE72764, 01GE72763, 01FM61959;01FM61955;01FM61962;01FM61968;01FM61970;01FM61960;01FM61963;01FM61965;01FM61966;01FM61971;01FM61972 Class III Blood products, for which the West Nile Viral testing performed was incomplete, were distributed. 30 B-2162-13
Red Blood Leukocytes Reduced 01GH15013, 01GH15012, 01GQ29464, 01GQ29427, 01GQ29454, 1GQ29460, 01GQ29461, 01GQ29463, 01GQ29465, 01GQ29467, 01GQ29469, 1GQ29474, 01GQ29453, 01GQ29458, 01GQ29468, 01KT32514, 01KT32524, 01KT32520, 01KT32524, 01KT32539, 01KT32530, 01KT32546, 01KT32536, 01KT32538, 01KT32543, 01KT32547, 01KT32541, 01KT325519, 01KT32544, 01KT32521, 01KT32528, 01KT32532, 01KT32522, 01FM62000, 01FM61998, 01GE72771, 01GT29616, 01GT29609, 01GT29610, 01GT29613, 01GT29614, 01GT29615, 01GT29590, 01KM53768, 01KM53770, 01KM53766, 01KM53776, 01KM53761, 01KM53764, 01KM53765, 01KM53775, 01KM53791, 01KM53774, 01KM53767, 01KM53769, 01KM53762 01KJ89623 Class III Blood products, for which West Nile Viral testing was incomplete, were distributed. 57 B-2163-13
Red Blood Cells (Apheresis) Leukocytes Reduced 01GQ29427 bag1 & bag2, 01GQ29429 bag 1 & bag2, 01GQ29430 bag2 , 01KG99421 bag1, 01KG99425 bag1, 01KG99422 bag1, 01KG99420 bag1, 01KG99423 bag1 & bag2, 01KG99424 bag 1 & bag 2, 01GQ29434 bag1, 01GQ29426 bag1 & bag2, 01GQ29435 bag1, and 01GQ29436 bag1 Class III Blood products, for which West Nile Viral testing was incomplete, were distributed. 18 B-2164-13
Red Blood Cells Leukocytes Reduced Irradiated 01GT29616 , 01GT29611 , 01GT29462 , 01GT29617 , 01GT29607, 01GQ29457 Class III Blood products, for which West Nile Viral testing was incomplete, were distributed. 6 B-2165-13
Platelets Leukocytes Reduced 01W51941 Class III Blood products, for which West Nile Viral testing was incomplete, were distributed. 1 B-2166-13
Plasma Frozen within 24 hours (FP24) 01KG99436, 01KG99447, 01KG99458, 01KG99446, 01KG99460, 01KT32538, 01KT32537, 01KT32524, 01KT32522, 01KT32546, 01KT32541, 01KT32511, 01KT32553, 01KT32518, 01KT32530, 01GE72773, 01GE72771, 01GE72769, 01FM61970, 01FM61967, 01FM61966, 01FM61963, 01FM62201, 01FM62202, 01FM61961, 01FM61665, 01FM61972, 01FM61997, 01FM61998, 01FM62000, 01FM62205, 01FM61965, 01FM61968, 01GH15015, 01GH15014, 01GQ29463, 01GQ29461, 01GQ29467, 01GQ29469, 01GQ29451, 01GT29591, 1GT29612, 01GH15018 Class III Blood products, for which West Nile Viral testing was incomplete, were distributed. 43 B-2167-13
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