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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Event Detail

Event ID 47936
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Louisville
State KY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-03-12
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern KY, IN

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Plasma Frozen 24kh00042, 24kj02064, 24kv27498, 24Kv27516 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. 4 B-2368-12
Plasma Frozen Cryoprecipitated Reduced 24KV27516 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. 1 B-2367-12
Cryoprecipitated AHF 24kv27472, 24kv27472, 24fs26136, 24kv27471, 24Kq87775, 24kq87781, 24ks89265, 24kc53652, 24kq87636, 24kq87773, 24kq87627, 24kg83999, 24kj01227, 24kj01229, 24fs26134, 24Kq87641, 24kj01246, 24kv27516, 24kc53663 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. 19 B-2366-12
Red Blood Cells Leukocytes Reduced 24kq88216, 24fl12269, 24fl12299, 24fq09131, 24kj01253, 24ky06776, 24kw64079, 24ks88434, 24kj01618, 24fq09123, 24kj01229, 24kg83549, 24ks88433, 24ke74629, 24fw46054, 24fw46053, 24kw64218, 24kj01615, 24kj01626, 24kj01623, 24kj01628, 24kj01619, 24kc53680, 24kj02246, 24kj02261, 24fs26136, 24kh00054, 24kj02257, 24kj02247, 24kj02258, 24kv27510, 24kw64211, 24kh00065, 24kw64079, 24kj01246, 24fw45965, 24fw45968, 24fw45978, 24fw45969, 24ks89235, 24Ks89249, 24Kr48076, 24Kq87775, 24fw44511, 24kq87776, 24kj01248, 24kg83511, 24y06759, 24kq87777, 24kg83586, 24kq87636, 24kq88224, 24kv27473, 24kw64144, 24kv27471, 24kj02226, 24kh00043, 24kc53663, 24kq87773, 24fw45987, 24yo6773, 24ks88087, 24kc53664, 24fq09047, 24fl12285, 24kh00043, 24kj02251, 24fw46056, 24kg83995, 24kg83992, 24fw46040, 24ks89259, 24ks89262, 24kj01244, 24fw45893, 24kj01231, 24fw45979, 24kj02067, 24kv27469, 24fs26245, 24kw64220, 24kv27472, 24kq88222, 24kc53656, 24fl12273, 24fl12272, 24fl12295, 24fj13592, 24fc59547, 24fq09128, 24fq09126, 24kj01622, 24kq88229, 24kj02069, 24ks89278, 24kg83515, 24fj13594, 24fw45979, 24kj02067, 24kv27469, 24fs26245, 24kw64220, 24kv27472, 24kq88222, 24kc53656, 24kj01598, 24ks89282, 24kh00059, 24kh00050, 24kh00046, 24kw64143, 24kh00067, 24fw45969, 24fq09134, 24fq09122, 24kg83505, 24ky06765, 24fw45882, 24fw45884, 24fw45890, 24kj01227, 24fq09189, 24kj01603, 24kg8399, 24kg83991, 24kq87641, 24fj13600, 24kw64067, 24fw46061, 24ks89281, 24ks89265, 24kj02264, 24kv27502, 24fw46042, 24fl12288, 24fl12283, 24kv27503, 24kq87781, 24fq09129, 24kg83585, 24kj02254, 24kj02245, 24kh00042, 24kj02243, Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. 144 B-2365-12
Red Blood Cells (Apheresis) Leukocytes Reduced 24fp10765, 24fp10775, 24fp10784, 24fp10801, 24fz07992, 24fp10935, 24fp10827 Part 1, 24fp10749 Part1, 24fp10745 Part1, 24fp10766 Part1, 24fp10773 Part1, 24fp10884, 24fr10880, 24fp10879, 24fz07990 Part1, 24fp10923 Part1, 24fp10926 Part1, 24ff07183 Part1, 24fr02802 Part1, 24fz07987 Part1, 24fz07988 Part1, 24fp10852 Part1, 24fp10842 Part1, 24fp10845 Part1, 24fp10848 Part1, 24fp10828 Part1, 24fp10825 Part1, 24fw44511, 24fp10884, 24fp10880, 24fp10879, 24fp10765, 24fp10775, 24fp10784, 24fp10801, 24fp10827Part2, 24fp10749 Part2, 24fp10745 Part2, 24fp10766 Part2, 24fp10773 Part2, 24fz07990 Part2, 24fp10923 Part2, 24fp10926 Part2, 24ff07183 Part2, 24fr02801, 24fr02802 Part2, 24fz07987 Part2, 24fz07988 Part2, 24fp10852 Part2, 24fp10842 Part2, 24fp10845 Part2, 24fp10848 Part2, 24fp10828 Part2, 24fp10825 Part2, Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. 54 B-2364-12
Fresh Frozen Plasma 24y06765, 24kj02110, 24fq09047, 24kq88222, 24kg83586, 24kv27503. 24fw45884, 24fw45890, 24fw46040, 24fw45893, 24fq09123, 24kj02112, 24kh00060, 24kh00056, 24kh00054, 24kq88216, 24kj02103, 24ks89254, 24fq09189, Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. 19 B-2369-12
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