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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Product Detail

Product Description Red Blood Cells (Apheresis) Leukocytes Reduced
Recall Number B-1040-13
Classification Class II
Code Info 11GN70827, 11FW16349, 11FW16353, 11FW16358, 11FW16361, 11FW16619, 11FY24514, 11FY24516, 11FY24521, 11FY24526, 11FY24532, 11FY24533, 11FY24534, 11FY24535, 11FY24540, 11FY24541, 11FY24544, 11GJ58516, 11GJ58527, 11GJ58548, 11GS78517, 11GS78508, 11GS78510, 11GS78530, 11GS78536, 11GS78538, 11GS78539, 11GS78544, 11GS78549, 11GS78552, 11GN73053, 11GN73056, 11GN73058, 11GN73061, 11GN73063, 11GN73086, 11GR56962, 11GR56963, 11GR56964, 11GR56965, 11GR56968, 11GR56970, 11GR56979, 11GS78652, 11GS78657, 11GS78665, 11GS78676, 11GS78677, 11GS78682, 11GS78711, 11GS78716, 11FZ58927, 11FZ58931, 11FZ58936, 11FZ58973, 11FZ58985, 11FZ58988, 11FZ58989, 11FZ58991, 11GY34414, 11FW17436, 11FW17438, 11FW17441, 11FW17448, 11FW17451, 11FW17453, 11FW17455, 11FZ61171, 11FZ61173, 11FZ61177, 11FZ61179, 11FZ61184, 11FZ61327, 11FZ61330, 11FZ61343, 11FZ61344, 11FZ61345, 11FZ61346, 11FZ61349, 11FZ61350, 11FZ61355, 11FS32639, 11FS32642, 11FS32646, 11FS32647, 11FS32651
Product Distributed Qty 86 units
Reason For Recall Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed.

Event Detail

Event Id 40757
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Saint Louis
State MO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2005-08-11
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX)