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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Event Detail

Event ID 55691
Product Type Biologics
Status Completed
Recalling Firm American National Red Cross (The)
City Philadelphia
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-03-17
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern PA, NJ, Washington D.C.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced Irradiated 022FN15436, 022FZ83294, 022FZ83380, 022FZ83466, 022LC74607 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. 5 units B-0679-14
Platelets Leukocytes Reduced 022GL83277 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. 1 unit B-0678-14
Red Blood Cells 022FN15375, 022FS93687 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. 2 units B-0677-14
Red Blood Cells (Apheresis) Leukocytes Reduced 022GJ24195 (2 units) Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. 2 units B-0676-14
Plasma Frozen within 24 hours (FP24) 022GQ51643, 022FL08688, 022FN15361, 022FN15424, 022FN15428, 022FN15432, 022FN15436, 022FQ86501, 022FQ86528, 022FQ86541, 022FQ88408, 022FQ88437, 022FS93673, 022FZ82472, 022FZ82606, 022FZ82953, 022FZ83360, 022GK38531, 022GK39776, 022GK39785, 022GP36563, 022GQ51649, 022GT40463, 022GV41774, 022GY40839, 022KE80677, 022KE80683, 022KH53827, 022LC74593, 022LC74598, 022LC74603, 022LC74781 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. 32 units B-0675-14
Fresh Frozen Plasma 022FG83722, 022FL08071, 022FL08086, 022FL08670, 022FL08701, 022FN15377, 022FP17540, 022FQ88491, 022FS93695, 022FZ82230, 022FZ82479, 022FZ82635, 022FZ82730, 022FZ82734, 022FZ82878, 022FZ82910, 022FZ82992, 022FZ83162, 022FZ83294, 022FZ83304, 022FZ83339, 022FZ83454, 022GK38673, 022GM65828, 022GP36534, 022GP36541, 022GQ51845, 022GQ51847, 022GQ51850, 022GT40921, 022GT40941, 022GT40945, 022GY40823, 022KE80672, 022KE80707, 022KE80962, 022KE80979, 022KH53831, 022KL79196, 022KL79258, 022LC73637, 022LC73696, 022LC74821, 022LZ49038, 022LZ49041, 022LZ49044, 022FZ82885, 022KE81215, 022LC74822, 022LC74824 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. 50 units B-0674-14
Red Blood Cells Leukocytes Reduced 022FS93673, 022FG83722, 022FL08670, 022FL08692, 022FL08701, 022FP17540, 022FQ86931, 022FQ86938, 022FQ86945, 022FZ83162, 022FZ83166, 022FZ83172, 022FZ83176, 022FZ83287, 022FZ83304, 022FZ83339, 022FZ83371, 022FZ83377, 022FZ83391, 022FZ83400, 022FZ83454, 022GJ26949, 022GT40909, 022GT40921, 022GT40927, 022GT40941, 022GT40945, 022KE80962, 022KE80970, 022KE80979, 022KE80982, 022KE80988, 022LC74593, 022LC74598, 022LC74603, 022LC74768, 022LC74781, 022LC74785, 022LC74821, 022FL08688, 022KE81220, 022LC74822, 022LC74824, 022LZ49041, 022GK39785, 022FN15363, 022FN15365, 022FN15382, 022GQ51845, 022GQ51649, 022KH53831, 022KH53839, 022KH53827, 022KH53836, 022FN15361, 022GQ51850, 022GQ51847, 022GP36543, 022FZ83350, 022FN15432, 022FZ83360, 022GP36563, 022KE81341, 022KE81333, 022GP36534, 022GP36553, 022LZ49044, 022KH53820, 022GP36557, 022FN15377, 022GQ51636, 022KH53846, 022GP36530, 022GP36541, 022GP36545, 022FN15428 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. 76 units B-0673-14
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