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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 Leukocytes Reduced
Recall Number B-1031-13
Classification Class II
Code Info 11FH01099, 11FH01108, 11FH01111, 11FH01123, 11FH01199, 11FH01346, 11FH01557, 11FH01867, 11FH01868, 11FH01869, 11FH01876, 11FH01877, 11FH01878, 11FH02075, 11FH02076, 11FH02085, 11FH02097, 11FH02100, 11FH02131, 11FH02138, 11FH02141, 11FH02148, 11FH02149, 11FH02154, 11FH03172, 11FH03601, 11FH03609, 11FH03712, 11FH03714, 11FH03723, 11FJ10087, 11FJ10110, 11FJ10250, 11FJ10355, 11FJ10451, 11FJ10504, 11FJ10537, 11FJ10570, 11FJ10894, 11FJ10969, 11FJ11026, 11FJ11488, 11FJ11646, 11FJ11779, 11FJ11815, 11FJ12078, 11FJ12079, 11FJ12349, 11FJ12381, 11FJ12495, 11FJ12498, 11FK06804, 11FK06844, 11FL23592, 11FL23594, 11FL23599, 11FL23600, 11FL23619, 11FL23621, 11FL23625, 11FL23627, 11FL23630, 11FL25145, 11FL29150, 11FL29155, 11FL29156, 11FL29714, 11FL29716, 11FL29717, 11FL29719, 11FL29728, 11FL29730, 11FL29732, 11FL31438, 11FL31441, 11FL31442, 11FL31444, 11FL31448, 11FL31966, 11FL31967, 11FL31968, 11FL31971, 11FL31979, 11FL31980, 11FL31983, 11FL31984, 11FL31986, 11FL33208, 11FL33211, 11FL33213, 11FL33214, 11FL33218, 11FL33239, 11FL33241, 11FM91579, 11FM93036, 11FM93038, 11FM93043, 11FM93044, 11FM93046, 11FM93047, 11FM93051, 11FM93055, 11FM93347, 11FM93348, 11FM93349, 11FM93351, 11FM93353, 11FM93354, 11FM93364, 11FM93366, 11FM93368, 11FM93370, 11FM93381, 11FM93576, 11FM93581, 11FM94273, 11FM94274, 11FM94276, 11FM94277, 11FM94278, 11FM94279, 11FM94280, 11FM94282, 11FM94284, 11FM94287, 11FM94288, 11FM94295, 11FM94301, 11FM95390, 11FM95940, 11FM95942, 11FM95946, 11FM95948, 11FM95949, 11FM96243, 11FM96248, 11FM96250, 11FM96260, 11FM96261, 11FM96263, 11FM96268, 11FM96292, 11FM96293, 11FM96304, 11FM96307, 11FM96747, 11FM96749, 11FM96758, 11FM96761, 11FM96764, 11FM96765, 11FM96767, 11FM96770, 11FM96771, 11FM96938, 11FM96940, 11FM96941, 11FM96942, 11FM96943, 11FM96947, 11FM96948, 11FM96949, 11FM97437, 11FM97440, 11FM97443, 11FM97447, 11FM97449, 11FM97465, 11FM97473, 11FM97475, 11FM97674, 11FM97675, 11FM97740, 11FM97741, 11FM97742, 11FM97756, 11FM97757, 11FM97995, 11FM97997, 11FM98015, 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11GR59648, 11GR59650, 11GR59653, 11GR59664, 11GR59669, 11GR59671, 11GR59672, 11GR59833, 11GR59843, 11GR59862, 11GR59863, 11GR59866, 11GR62164, 11GR62182, 11GR62207, 11GR62210, 11GR62226, 11GR62232, 11GR62316, 11GR62333, 11GR62352, 11GR62366, 11GR62387, 11GR62417, 11GR63266 (2 units), 11GR63267, 11GR63301, 11GR63304, 11GR64955, 11GR64957, 11GR64974, 11GR64976, 11GR64985, 11GR64987, 11GR66957, 11GR66958, 11GR66960, 11GR66969, 11GR66970, 11GR66971, 11GR66973, 11GR66974, 11GR66977, 11GR66979, 11GR66980, 11GR67209, 11GR67212, 11GR67213, 11GR67214, 11GR67216, 11GR67217, 11GR67218, 11GR67219, 11GR67221, 11GR67222, 11GR67223, 11GR67226, 11GR67229, 11GR67230, 11GR67231, 11GR67235, 11GR67236, 11GR67242, 11GR67245, 11GR67450, 11GR67451, 11GR67452, 11GR67453, 11GR67454, 11GR67455, 11GR67919, 11GR67921, 11GR67922, 11GR67924, 11GR67925, 11GR67930, 11GR68064, 11GR68065, 11GR68067, 11GR68068, 11GR68069, 11GR68074, 11GR68095, 11GR68111, 11GS77544, 11GS77556, 11GS77575, 11GS77582, 11GS77592, 11GS77596, 11GS77607, 11GS77637, 11GS77645, 11GS77673, 11GS77676, 11GS77683, 11GS77684, 11GS77699, 11GS77700, 11GS77704, 11GS77709, 11GS77715, 11GS77716, 11GS77722, 11GS77730, 11GS77733, 11GS77736, 11GS77750, 11GS78289, 11GS78293, 11GS78295, 11GS78298, 11GS78328, 11GS78560, 11GS78620, 11GS78621, 11GS78625, 11GS78626, 11GS78632, 11GS78636, 11GS78724, 11GS78980, 11GS78983, 11GS78986, 11GS78991, 11GS78994, 11GS78998, 11GS79000, 11GS79003, 11GS79004, 11GS79006, 11GS79194, 11GS79195, 11GS79196, 11GS79198, 11GS79199, 11GS79200, 11GS79202, 11GS79206, 11GS79209, 11GS79212, 11GS80175, 11GS80181, 11GS80433, 11GS80434, 11GS80449, 11GS80450, 11GS80649, 11GS80653, 11GS80654, 11GS80656, 11GS80657, 11GS80665, 11GS80666, 11GS81083, 11GS81086, 11GS81088, 11GS81089, 11GS81097, 11GS81099, 11GS81101, 11GS81104, 11GS81107, 11GS81640, 11GS81641, 11GS81645, 11GS81662, 11GS82405, 11GS82407, 11GS82421, 11GS83106, 11GS83108, 11GS83110, 11GS83114, 11GS83119, 11GS83122, 11GS83124, 11GS83129, 11GS83132, 11GS83133, 11GS83142, 11GS83257, 11GS83259, 11GS83261, 11GS83262, 11GS83265, 11GS83266, 11GS83278, 11GS83287, 11GS83686, 11GS83692, 11GS83693, 11GS83695, 11GS83696, 11GS83714, 11GS83718, 11GS83724, 11GS84092, 11GS84093, 11GS84098, 11GS84100, 11GS84361, 11GS84362, 11GS84365, 11GS84367, 11GS84379, 11GS84381, 11GS85775, 11GS85777, 11GS85786, 11GS85837, 11GS85842, 11GS85847, 11GS85854, 11GS85858, 11GT58843, 11GT58844, 11GT58859, 11GT58869, 11GV68445, 11GV68446, 11GV68453, 11GV68457, 11GX76199, 11GY34094, 11GY34096, 11GY34099, 11GY34362, 11GY34363, 11GY34368, 11GY34369, 11GY34370, 11GY34372, 11GY34378, 11GY34379, 11GY34381, 11GY35074, 11GY35084, 11GY35085, 11GY35089, 11GY35092, 11GY35095, 11GY35387, 11GY35389, 11GY35399, 11GY35971, 11GY35972, 11GY35974, 11GY35980, 11GY36054, 11GY36058, 11GY36061, 11GY36062, 11GY36064, 11GY36067, 11GY36068, 11GY36071, 11GY36736, 11GY36737, 11GY36745, 11GY36759, 11GY36764, 11GY36766, 11GY37172, 11GY37175, 11GY37182, 11GY37183, 11GY37558, 11GY37559, 11GY37582, 11KC12599, 11KC12654, 11KC12661, 11KC12808, 11KC12896, 11KF17036, 11KF17038, 11KF17051, 11KH02819, 11KH02821, 11KH02824, 11KH02834, 11KL06587, 11KL06630, 11KL06654, 11KL06933, 11KL07115, 11KL07143, 11KL07262, 11KL07416, 11KL07741, 11KL07931, 11KN03648, 11KN03649, 11KN03653, 11KN03655, 11KN03658, 11KN03660, 11KN05127, 11KN05132, 11KN05133, 11KN05156, 11KN05961, 11KN05962, 11KN05969, 11KN05973, 11KN05978, 11KN05983, 11KN06081, 11KN06084, 11KN06086, 11KN06090, 11KN06108, 11KN06110, 11KN06172, 11KN06174, 11KN06175, 11KN06176, 11KN06177, 11KN06179, 11KN06180, 11KN06334, 11KN06339, 11KN06397, 11KN06403, 11KN06800, 11KN06802, 11KN06803, 11KN06805, 11KN06809, 11KN06810, 11KN06811, 11KN06819, 11KN06823, 11KX06223, 11KX06630, 11KX06718, 11KY07816, 11KY07826, 11KY07827, 11KY07829, 11LR00675, 11LR00684, 11LR01100, 11LZ27409, 11LZ27430, 11LZ27463, 11LZ27498, 11LZ27848, 11LZ28398, 11LZ28640, 11LZ28921, 11LZ28943, 11LZ28962, 11LZ29005, 11LZ29039, 11GM82871, 11GM82880, 11GN72309, 11FW17623, 11GM81509, 11GS80452, 11GM84005, 11FJ11726, 11GR63266, 11FY28154, 11FW23207, 11FL31447, 11KL07765, 11FZ64297, 11FY28838, 11FX00711, 11GJ67548
Product Distributed Qty 1647 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)