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 |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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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