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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 01Y57775 ; 01Y57776; 01Y57777; 01Y57778; 01Y57780; 01Y57781; 01Y57782; 01Y57783; 01Y57784 Class III Blood products, collected using expired blood collection sets, were distributed. American National Red Cross (the)
Biologics Platelets 01Y57775 ; 01Y57776; 01Y57780; 01Y57781; 01Y57783 Class III Blood Products, which were collected in an expired collection bag, were distributed. American National Red Cross (the)
Biologics Plasma Frozen within 24 hrs After Phlebotomy 01Y57775; 01Y57778; 01Y57781; 01Y57783 Class III Blood products, collected using expired blood collection sets, were distributed. American National Red Cross (the)
Biologics Source Plasma 380001943, 380002525, 380004157, 380005454, 380006271, 380007553, 380007713, 380002110. 380001521, 380003365, 380003625, 380005713, 380006093, 380008037, 380008629, 380008896, 380009446, 380009942, 380010141, 380010432, 380010668, 380011122, 380011476, 380012030, 380012185, 380012470, 380012689, 380013021, 380013200, 380013643, 380013915, 380014838, 380015927, 380016011, 380016486. Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed Biomat USA, Inc.
Biologics Red Blood Cells Leukocytes Reduced. 011FL31359, 011FL31370, 011FL31413, 011FL31424, 011FS36104, 011FS35106, 011FS36117, 011FS35118, 011FS36121, 011GG39706, 011GG39708, 011GJ65355, 011GK83746, 011GH83753, 011GK83767, 011GK83774, 011GK83775, 011GK83779, 011GM89817, 011GM89820, 011GM89821, 011GM89825, 011GM89826, 011GM89839, 011GM89842, 011GM89851, 011GN80908, 011GN80912, 011GN80914, 011GN80916, 011GN80919, 011GN80937, 011GN80938, 011GN80941, 011GN80949, 011GQ72541, 011GQ72543, 011GQ72545, 011GQ72547, 011GQ72548, 011GR66347, 011GR66349, 011GR66353, 011GR66357, 011GR66359, 011GR66361, 011GR66362, 011GR66363, 011GR66380, 011GR66387 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF. . 011FL31370, 011FL31376, 011FL31413, 011FS35106, 011FS36117, 011FS35118, 011GG39706, 011GG39708, 011GN80937, 011GN80938, 011GN80941, 011GN80946, 011GN80949, 011GQ72533, 011GQ72541, 011GQ72543, 011GQ72545, 011GQ72547, 011GQ72548 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma. 011GJ65355, 011GK83777, 011GM89839, 011GM89842, 011GM89844, 011GM89849, 011GR66380 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Recovered Plasma 011FL31346, 011FL31353, 011FL31376, 011GG39708, 011GK83777, 011GN80908, 011GN80912, 011GN80914, 011GN80919, 011GN80937, 011GN80938, 011GN80941, 011GN80946, 011GN80949, 011GQ72540, 011GQ72541, 011GQ72545, 011GQ72547, 011GQ72548, 011GR66347, 011GR66349, 011GR66353, 011GR66357, 011GR66359, 011GR66361, 011GR66362, 011GR66363, 011GR66387 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells. . 011GQ72533 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Plasma Frozen . 011GK83748 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Whole Blood 06FS97949, 06FS97950,06FS97952 Class III Blood products, collected using expired blood collection sets, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 06GY30608, 06GY30609, 06GY306011 Class III Blood products, collected using expired blood collection sets, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 06GY306014 Class III Blood products, collected using expired blood collection sets, were distributed. American National Red Cross (The)
Biologics Source Plasma 4210100174; 4210099656;4210098041;4210096392 4210094813;4210093350;4210091935;4210090417 4210088901;4210087397;4210085959;4210084393 4210076890;4210075903;4210075465;4210074628 4210074229;4210073382;4210072979 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed CSL Plasma Inc
Biologics Red Blood Cells Leukocytes Reduced 02LJ81794 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing 02LJ81794 Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Fresh Frozen Plasma 003KT21845, 003KT22093, 003KT21844, 003KT21846, 003KP40859, 003KT22248, 003KF32591, 003KT23823, 003KF30043, 003KJ21806, 003KJ21790, 003KP40848, 003KP40870, 003KF30502, 003KJ21312, 003KJ21314, 003KT23926, 003KJ21345, 003KJ21727, 003KJ21729, 003KT21947, 003KT21814, 003KP40853, 003KJ21368, 003KJ21372, 003KT23988, 003KT24059, 003KT24152, 003KT24159, 003KP47200, 003KT24275, 003KT24288, 003KT24318, 003KJ21821, 003KP40829, 003KP40832, 003KP40858, 003KT24112, 003KT21927, 003KT23932, 003KT23928, 003KT23941, 003KT24281, 003KT21808, 003KT21831, 003KT21931, 003KP40866, 003KP40872, 003KF30085, 003KT22261, 003KT22262, 003KF32600, 003KQ40068, 003KT23894, 003KT23897, 003KT23940, 003KT23945, 003KP46744, 003KP46750, 003KJ21375, 003KJ21395, 003KJ21435, 003KQ40330, 003KT24018, 003KT24021, 003KT24114, 003KT24116, 003KT24145, 003KT24269, 003KT24286, 003KT24302, 003KF30497, 003KF30500, 003KF30530, 003KT22122, 003KT22128, 003KT22135, 003KT24171, 003KT24247, 003KT21200, 003KT21201, 003KT21204, 003KT24291, 003KT21821, 003KT21843, 003KP40837, 003KP40862, 003KP40871, 003KF3000, 003KF30139, 003KT22110, 003KF30504, 003KT22132, 003KT22133, 003KT22136, 003KT23831, 003KJ21351, 003KJ21392, 003KJ21427, 003KJ21436, 003KT23991, 003KT24051, 003KJ21699, 003KT24283, 003KT24301, 003KT24311, 003KT24315, 003KJ21804, 003KJ21850, 003KT21836, 003KT21842, 003KP40840, 003KT21981, 003KF30007, 003KF30073, 003KF30197, 003KT22131, 003KT22134, 003KT24118, 003KT21938, 003KJ21782, 003KT21849, 003KQ40059, 003KT21834, 003KQ40067, 003KJ21616, 003KJ21859, 003KJ21861, 003KT24014, 003KT21820, 003KT21824, 003KT21825, 003KT21827, 003KT21830, 003KT21837, 003KT21840, 003KP40838, 003KP40839, 003KF30037, 003KT21839, 003KF30040, 003KF30048, 003KF30056, 003KT22079, 003KT22082, 003KF30517, 003KT22259, 003KQ40066, 003KT23929, 003KT23933, 003KT23949, 003KT23954, 003KT23955, 003KJ21361, 003KJ21362, 003KJ21394, 003KJ21397, 003KT23970, 003KT24007, 003KT24199, 003KJ21774, 003KJ21784, 003KJ21785, 003KT24274, 003KT24330, 003KJ21839, 003KJ21852, 003KF30512, 003KT24327, 003KP40863, 003KF30057, 003KT22080, 003KT22081, 003KT22084, 003KT22255, 003KJ21305, 003KT24015, 003KT24300, 003KT22292, 003KT23636, 003KT23757, 003KT24011, 003KT22083, 003KT21810, 003KT24148, 003KJ21843, 003KJ21846, 003KT21203, 003KT21209, 003KT21813, 003KP40857, 003KF30097, 003KT22111, 003KF30507, 003KF30515, 003KT22119, 003KT23925, 003KJ21428, 003KT24077, 003KT24113, 003KJ21717, 003KJ21730, 003KP47192, 003KP47196, 003KP47197, 003KP47199, 003KJ21796, 003KJ21880, 003KT24047, 003KT21206, 003KT21848, 003KP40827, 003KP40835, 003KP40852, 003KP40855, 003KF30011, 003KF30016, 003KF30025, 003KF30091, 003KF32594, 003KF32604, 003KF32615, 003KQ40062, 003KT23836, 003KT24047, 003KJ21863, 003KT21816, 003KT21818, 003KT23805, 003KT23819, 003KJ21348, 003KT24246, 003KT23811, 003KT24312, 003KJ21313, 003KT21972, 003KT22093, 003KJ21449, 003KT21940, 003KT21970, 003KJ21308, 003KJ21697, 003KP46746, 003KT23636, 003KT23816, 003KT24251, 003KF30027, 003KF30090, 003KT21847, 003KP40868, 003KF30046, 003KT22123, 003KF30513, 003KT24255, 003KP47191, 003KP47193, 003KF30020, 003KT22197, 003KT22239, 003KT24057, 003KT24065, 003KP47188, 003KP47203, 003KT22253, 003KT24074, 003KT24074, 003KT22243, 003KT24063, 003KT23838, 003KT24048, 003KT24266, 003KJ21878, 003KF30104, 003KJ21315, 003KT22249 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 003KJ21504, 003KJ21506, 003KT24309, 003KF30063, 003KJ21466, 003KT23946, 003KF30506, 003KF30523, 003KJ21504, 003KJ21299, 003KT23611, 003KT23824, 003KT21985, 003KT23919, 003KT24309, 003KF32619, 003KF32625, 003KT23915, 003KT23919, 003KF30506, 003KT23946, 003KT23952, 003KT23694, 003KT23694, 003KT23952, 003KT24164, 003KJ21506, 003KJ21299, 003KT23653, 003KT24257, 003KF30063, 003KJ21244, 003KT23610, 003KT23611, 003KT23653, 003KT24257, 003KQ40055, 003KT23830, 003KJ21466, 003KT23915, 003KF32619, 003KF32625, 003KJ21244, 003KT23610 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced Irradiated 003KT21971, 003KF30025, 003KT21764, 003KT34048, 003KT24315, 003KQ40318, 003KQ40327, 003KT22197, 003KT24014, 003KT24104, 003KJ21494, 003KT24311, 003KJ21691, 003KT24305, 003KJ21229, 003KJ21246, 003KT24051, 003KJ21774, 003KT24314, 003KT24320, 003KJ21224, 03KQ40325, 003KT23980, 003KT24038, 003S42158, 003KT21983, 003KT24047, 003KT24103, 003KJ21294, 003KT21229, 003KT23982, 003KJ21578, 003KT24199, 003KT23808, 003KT23816, 003KT23821, 003KT23926 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced Washed 003KJ21693 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced 003KJ21586, 003KT23643, 003V47039, 003KP40835, 003KT21821, 003KT22063, 003KT22054, 003KT21840, 003KT23957, 003KT23960, 003KT23964, 003KT23972, 003V47019, 003V47022, 003KT24291, 003V47045, 003KT23619, 003KF30512, 003KF30513, 003KT22239, 003KT22255, 003KT24053, 003KT21818, 003KF30034, 003KF30166, 003KJ21302, 003KJ21397, 003KJ21402, 003KJ21403, 003KJ21450, 003KJ21454, 003KJ21467, 003KJ21579, 003KJ21580, 003KT21781, 003KT21981, 003KT22240, 003KT23608, 003KT23617, 003KT23759, 003KT23929, 003KT23941, 003KT23949, 003KT24011, 003KT24265, 003V47015, 003V47034, 003V47046, 003KT24328, 003KP47196, 003KJ21696, 003KJ21434, 003KT21212, 003KT21233, 003KT23633, 003KT23651, 003KT23658, 003KT23990, 003KT24315, 003V47161, 003KF30139, 003KF30502, 003KF30507, 003KF30509, 003KF30515, 003KJ21353, 003KJ21811, 003KT21810, 003KT21825, 003KT21849, 003KT21927, 003KT21933, 003KT21986, 003KT22044, 003KT22046, 003KT22048, 003KT22070, 003KT22131, 003KT22134, 003KT22137, 003KT22200, 003KT22206, 003KT22262, 003KT23625, 003KT23681, 003KT24068, 003KT24108, 003KT24306, 003KJ21490, 003KJ21811, 003KT22194, 003KT22093, 003KJ21428, 003KJ21461, 003KT22208, 003KT23814, 003KT23940, 003KT23950, 003KJ21338, 003KT23916, 003KJ21340, 003KJ21436, 003KJ21796, 003KP47186, 003KT21236, 003KT21812, 003KT21813, 003KT21814, 003KT21847, 003KT22049, 003KT22122, 003KT22128, 003KT22129, 003KT22132, 003KT22135, 003KT22253, 003KT23626, 003KT23663, 003KT23830, 003KT24154, 003KJ21936, 003KT22042, 003KT22243, 003KJ21393, 003KF30197, 003KJ21730, 003KP40836, 003KT21945, 003KT23894, 003KT21200, 003KJ21804, 003KJ21346, 003KJ21782, 003KJ21784, 003KT22305, 003KT24057, 003KJ21503, 003KJ21348, 003KF30000, 003KF32591, 003KJ21251, 003KJ21312, 003KJ21584, 003KJ21695, 003KT22081, 003KF30132, 003KT21757, 003KT21934, 003KT21938, 003KT21940, 003KT21970, 003KT22061, 003KJ21814, 003KP47197, 003KJ21313, 003KT23624, 003KT24157, 003KP47203, 003KJ21777, 003KT24271, 003KJ21356, 003KF30057, 003KF30073, 003KF32615, 003KJ21245, 003KJ21304, 003KJ21308, 003KJ21396, 003KJ21439, 003KJ21361, 003KJ21508, 003KJ21585, 003KP40871, 003KT21830, 003KT21930, 003KT21943, 003KT21947, 003KT22066, 003KT22186, 003KT22187, 003KT22192, 003KT23616, 003KT23648, 003KT23654, 003KT23918, 003KT23943, 003V47028, 003V47158, 003KF30517, 003KT21748, 003KT21750, 003KT21760, 003KT21770, 003KT21774, 003KT22062, 003KT22119, 003KT22051, 003KT24168, 003KT24249, 003KT24333, 003KJ21818, 003KJ21830, 003KJ21878, 003KF32594, 003KT21834, 003KT21976, 003KT22307, 003KJ21500, 003KF30097, 003KJ21463, 003KJ21502, 003KJ21583, 003KP46747, 003KT21978, 003KT22069, 003KT22248, 003KT22298, 003KT23991, 003KJ21342, 003KJ21359, 003KP40829, 003KF30114, 003KJ21290, 003KJ21293, 003KJ21426, 003KP46746, 003KT21844, 003KT21985, 003KT22108, 003KT22252, 003KT22280, 003KT22287, 003KT23661, 003KT23680, 003KT23819, 003KT23824, 003KT23826, 003KT23958, 003KT23962, 003KT24019, 003KT24066, 003KT24114, 003KT24149, 003KJ21725, 003KP47188, 003KP47192, 003KT24334, 003KJ21362, 003KT24286, 003KT24308, 003KT22057, 003KT22083, 003KT22299, 003KT22306, 003KT22308, 003KT22310, 003KT23994, 003KF30010, 003KF30016, 003KJ21575, 003KT23613, 003KT23642, 003KT24049, 003KT24074, 003KT24246, 003KJ21848, 003KF30504, 003KJ21859, 003KJ21398, 003KQ40057, 003KQ40066, 003KT21209, 003KT24145, 003KT24148, 003KT24162, 003V47041, 003V47155, 003KT21816, 003KT24023, 003KJ21839, 003KJ21307, 003KJ21399, 003KJ21247, 003KF30530, 003KQ40054, 003KQ40065, 003KQ40068, 003KT22210, 003KT24318, 003KT21234, 003KT24040, 003KT24063, 003V47026, 003V47040, 003KJ21427, 003KJ21616, 003KP40866, 003KP46748, 003KQ40055, 003KT21231, 003KT21838, 003KT24302, 003KT22079, 003KT24301, 003KJ21850, 003KJ21827, 003KJ21351, 003KT21842, 003KT21846, 003KT21972, 003KT22105, 003KT22106, 003KT22110, 003KT22111, 003V47025, 003KT24021, 003KF32604, 003KP40868, 003KF30164, 003KJ21314, 003KJ21492, 003KJ21779, 003KJ21846, 003KT24255, 003KJ21699, 003KP40838, 003KT21931, 003KT21949, 003KT22123, 003KT22136, 003KT23812, 003KF30104, 003KJ21238, 003KJ21377, 003KT22082, 003KT22184, 003KP40837, 003KT21843, 003KT21848, 003KJ21775, 003KJ21780, 003KJ21790, 003KJ21845, 003KJ21855, 003KF30091, 003KF30121, 003KJ21315, 003KP40860, 003KP40862, 003KT21207, 003KT21837, 003KT23602, 003KJ21391, 003KT22183, 003KT22189, 003KT22209, 003KT23635, 003KJ21843, 003KF32618, 003KT22060, 003KT24147, 003KJ21364, 003KT21216, 003V47159, 003V47162, 003KJ21686, 003KY24153, 003KT24274, 003KJ21857, 003KT22268, 003KT22278, 003KT24105, 003KT24264, 003KT24262, 003KT24266, 003KF30011, 003KF30037, 003KF30046, 003KJ21394, 003KJ21433, 003KJ21452, 003KJ21459, 003KJ21465, 003KJ21577, 003KP40839, 003KP40848, 003KP40863, 003KP46744, 003KT21206, 003KT21768, 003KT21975, 003KT21977, 003KT22117, 003KT22203, 003KT22259, 003KT22269, 003KT23678, 003KT23679, 003KT23831, 003KT23954, 003KT23955, 003KT23970, 003KT23975, 003KT24262, 003KT24266, 003KJ21216, 003KJ21333, 003KJ21335, 003KJ21345, 003KJ21372, 003KJ21449, 003KT21203, 003KT22272, 003KT23607, 003KT23627, 003KT23629, 003KT23631, 003KT23838, 003KT24009, 003KJ21727, 003KJ21729, 003KT24169, 003KP47191, 003KP47200, 003KT24161, 003KJ21368, 003KJ21834, 003KT24018, 003KT24152, 003KT24275, 003KJ21837, 003KF30007, 003KF30056, 003KF30082, 003KF30497, 003KJ21499, 003KJ21507, 003KJ21581, 003KJ21785, 003KT24247, 003KF30048, 003KT21755, 003KT21766, 003KT21973, 003KT21979, 003KT23614, 003KT23656, 003KT24059, 003S42155, 003KP40827, 003KP40861, 003KQ40330, 003KT23897, 003V47160, 003KT21747, 003KT21753, 003KJ21371, 003KP40870, 003V47035, 003KJ21880, 003KF30085, 003KF30027, 003KF30040, 003KF30090, 003KJ21305, 003KJ21424, 003KP40831, 003KP40853, 003KT21235, 003KT22267, 003KT22296, 003KT22303, 003KT23811, 003KT23836, 003KT23925, 003KT23945, 003KP40855, 003KT21759, 003KT22056, 003KT22133, 003KT23665, 003KJ21821, 003KT23665, 003KT24312, 003KF30043, 003KF30500, 003KQ40324, 003KT21831, 003KT22080, 003KT22084, 003KT22107, 003KT23618, 003KT23921, 003KT23985, 003KT23996, 003KT24077, 003KT24312, 003V47023, 003KF32616, 003KT21777, 003KT21778, 003KT23647, 003KT23660, 003KT23823, 003KT23988, 003KJ21806, 003KF30020, 003KT21850, 003KJ21392, 003KJ21614, 003KT21820, 003KT21827, 003KT21836, 003KP40832, 003KT22293, 003KT24171, 003KP47199, 003KT24281, 003KJ21306, 003KJ21437, 003KJ21486, 003KJ21588, 003KQ40052, 003KQ40058, 003KQ40059, 003KT22274, 003KT23606, 003KT24039, 003KT24045, 003KT24065, 003V47027, 003KP46750, 003KP48057, 003KT21218, 003KT21219, 003KT22052, 003KT22249, 003KT21204, 003V47153, 003KF32610, 003KT21841, 003KT23639, 003V47152, 003KJ21717, 003KT24288, 003KJ21435, 003KJ21697, 003KT23603, 003V47033, 003KT24159, 003KQ40067, 003KF30060, 003KJ21292, 003KJ21295, 003KJ21430, 003KJ21432, 003KJ21448, 003KJ21457, 003KP40872, 003KT21201, 003KT21213, 003KT22196, 003KT23928, 003KT23932, 003KT23933, 003KT22291, 003KT22304, 003KJ21365, 003KT24269, 003KJ21223, 003KT21773, 003KJ21509, 003KP40840, 003KP40852, 003KP40858, 003KP40859, 003KT22301, 003KT24327, 003KT24330, 003KT21808, 003KJ21310, 003KT22072, 003KJ21446, 003KT24118, 003KT24144, 003KF32600, 003KF32606, 003KJ21496, 003KJ21498, 003KQ40061, 003KQ40062, 003KT21752, 003KT21845, 003KT23922, 003KT21824, 003KT22109, 003KT21237, 003KJ21863, 003S42153, 003S42156, 003KJ21375, 003KJ21376, 003KJ21395, 003KJ21401 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Blood and Blood Products for Reprocessing 003KJ21463, 003KT23606, 993KF30121, 003KF30164, 003KF30166, 003KF30180, 003KF30509, 003KF32606, 003KF32616, 003KJ21212, 003KJ21216, 003KJ21223, 003KJ21224, 003KJ21229, 003KJ21238, 003KJ21241, 003KJ21245, 003KJ21246, 003KJ21247, 003KJ21251, 003KJ21290, 003KJ21292, 003KJ21293, 003KJ21294, 003KJ21295, 003KJ21304, 003KJ21306, 003KJ21310, 003KJ21311, 003KJ21333, 003KJ21335, 003KJ21338, 003KJ21340, 003KJ21342, 003KJ21346, 003KJ21353, 003KJ21359, 003KJ21364, 003KJ21365, 003KJ21371, 003KJ21376, 003KJ21377, 003KJ21391, 003KJ21396, 003KJ21398, 003KJ21401, 003KJ21402, 003KJ21403, 003KJ21424, 003KJ21426, 003KJ21430, 003KJ21432, 003KJ21437, 003KJ21439, 003KJ21446, 003KJ21448, 003KJ21450, 003KJ21452, 003KJ21454, 003KJ21457, 003KJ21459, 003KJ21461, 003KJ21465, 003KJ21467, 003KJ21486, 003KJ21488, 003KJ21490, 003KJ21492, 003KJ21494, 003KJ21496, 003KJ21498, 003KJ21499, 003KJ21500, 003KJ21502, 003KJ21503, 003KJ21507, 003KJ21508, 003KJ21509, 003KJ21575, 003KJ21578, 003KJ21579, 003KJ21580, 003KJ21581, 003KJ21583, 003KJ21584, 003KJ21585, 003KJ21586, 003KJ21588, 003KJ21686, 003KJ21691, 003KJ21693, 003KJ21695, 003KJ21696, 003KJ21725, 003KJ21811, 003KJ21814, 003KJ21816, 003KJ21818, 003KJ21827, 003KJ21830, 003KJ21834, 003KJ21848, 003KP40831, 003KP40836, 003KP40850, 003KP40860, 003KP40861, 003KP40865, 003KP46747, 003KP46748, 003KP47186, 003KQ40052, 003KQ40054, 003KQ40057, 003KQ40058, 003KQ40061, 003KQ40065, 003KQ40318, 003KQ40324, 003KQ40325, 003KQ40327, 003KT21207, 003KT21212, 003KT21213, 003KT21216, 003KT21219, 003KT21229, 003KT21231, 003KT21233, 003KT21234, 003KT21235, 003KT21236, 003KT21237, 003KT21747, 003KT21748, 003KT21752, 003KT21753, 003KT21755, 003KT21757, 003KT21759, 003KT21763, 003KT21764, 003KT21766, 003KT21768, 003KT21772, 003KT21773, 003KT21774, 003KT21777, 003KT21778, 003KT21781, 003KT21782, 003KT21812, 003KT21841, 003KT21850, 003KT21971, 003KT21973, 003KT21975, 003KT21976, 003KT21977, 003KT21978, 003KT21979, 003KT21986, 003KT22042, 003KT22046, 003KT22048, 003KT22049, 003KT22051, 003KT22052, 003KT 22054, 003KT22056, 003KT22057, 003KT22060, 003KT22061, 003KT22062, 003KT22063, 003KT22066, 003KT22069, 003KT22070, 003KT22072, 003KT22105, 003KT22106, 003KT22107, 003KT22108, 003KT22109, 003KT22117, 003KT22137, 003KT22183, 003KT22184, 003KT22186, 003KT22187, 003KT22189, 003KT22192, 003KT22194, 003KT22196, 003KT22200, 003KT22203, 003KT22206, 003KT22208, 003KT22209, 003KT22210, 003KT22240, 003KT22245, 003KT22252, 003KT22267, 003KT22268, 003KT22269, 003KT22272, 003KT22274, 003KT22278, 003KT22280, 003KT22287, 003KT22291, 003KT22292, 003KT22293, 003KT22296, 003KT22298, 003KT22299, 003KT22301, 003KT22304, 003KT22305, 003KT22306, 003KT22307, 003KT22310, 003KT23602, 003KT23603, 003KT23607, 003KT23608, 003KT23613, 003KT23614, 003KT23616, 003KT23617, 003KT23618, 003KT23619, 003KT23624, 003KT23625, 003KT23626, 003KT23627, 003KT23629, 003KT23631, 003KT23633, 003KT23635, 003KT23639, 003KT23642, 003KT23643, 003KT23647, 003KT23648, 003KT23651, 003KT23654, 003KT23660, 003KT23663, 003KT23665, 003KT23678, 003KT23679, 003KT23680, 003KT23681, 003KT23757, 003KT23759, 003KT23808, 003KT23812, 003KT23814, 003KT23821, 003KT23834, 003KT23839, 003KT23916, 003KT23918, 003KT23921, 003KT23922, 003KT23935, 003KT23943, 003KT23950, 003KT23957, 003KT23958, 003KT23960, 003KT23962, 003KT23964, 003KT23965, 003KT23972, 003KT23975, 003KT23985, 003KT23990, 003KT23996, 003KT24009, 003KT24019, 003KT24023, 003KT24038, 003KT24039, 003KT24040, 003KT24045, 003KT24049, 003KT24055, 003KT24066, 003KT24068, 003KT24103, 003KT24104, 003KT24105, 003KT24108, 003KT24144, 003KT24147, 003KT24149, 003KT24154, 003KT24157, 003KT24161, 003KT24162, 003KT64164, 003KT24166, 003KT24168, 003KT24169, 003KT24262, 003KT24264, 003KT24271, 003KT24293, 003KT24305, 003KT24306, 003KT24314, 003S42153, 003S42155, 003S42156, 003S42158, 003V47015, 003V47016, 003V47019, 003V47022, 003V47023, 003V47025, 003V47026, 003V47027, 003V47028, 003V47033, 003V47034, 003V47035, 003V47039, 003V47040, 003V47041, 003V47045, 003V47046, 003V47152, 003V47153, 003V47155, 003V47158, 003V47159, 003V47160, 003V47161, 003V47162, 003KJ21356, 003KJ21393, 003KT21218, 003KT21770, 003KT21983, 003KT23656, 003KT21930, 003KT21934, 003KT21943, 003KT21945, 003KT21949, 003KT22044 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced 02LC88260 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 02KH21573 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. American Red Cross Blood Services
Biologics Source Plasma 0190528263; 0190526052; 0190512784 Class II Blood products, which were collected from a donor with a history of high risk behaviors, were distributed. Csl Bioplasma Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 84LJ01588 Part 1; 84LJ01588 Part 2 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 84J09758 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 02FV16140; 02FV14910 Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 02FV14910 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics 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. American National Red Cross (The)
Biologics 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. American National Red Cross (The)
Biologics 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. American National Red Cross (The)
Biologics 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. American National Red Cross (The)
Biologics 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. American National Red Cross (The)
Biologics 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. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 02KH08386 Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. American Red Cross Blood Services
Biologics Recovered Plasma 02KH05241 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 02KH05241 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 02GJ12175; 02KH29581 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American Red Cross Blood Services
Biologics Recovered Plasma 02GG58419 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 02GG58419 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells 6880697 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced W117008201670 Class II Blood product, collected from a donor who received a mumps, measles , rubella (MMR) vaccination, was distributed. Blood Centers of the Pacific
Biologics Platelets Pheresis Leukocytes Reduced 12KJ48233, 12KJ48243, 12KJ48251, 12KJ48263, 12KJ48278, 12KJ48287, 12KJ48297, 12KJ48305, 12KJ48315, 12KJ48327, 12KJ48338, 12KJ48346, 12KJ48360, 12KJ48388, 12KJ48423, 12KJ48433, 12KJ48443, 12KJ48454, 12KJ48467, 12KJ48479, 12KJ48484, 12KJ48497, 12KJ48509, 12KJ48524, 12KJ48555, 12KJ48575, 12KJ48588, 12KJ48606, 12KJ48614, 12KJ48626, 12KJ48639, 12KJ48648, 12KJ48656, 12KJ48678, 12KJ48702, 12KJ48721, 12KJ48740, 12KJ48746, 12KJ48756, 12KJ48768, 12KJ48787, 12KJ48791, 12KJ48801, 12KJ48816, 12KJ48827, 12KJ48848, 12KJ48862, 12KJ48879, 12KJ48892, 12KJ48901, 12KJ48923, 12KJ48930, 12KJ48946, 12KJ48955, 12KJ48966, 12KJ48978, 12KJ48994, 12KJ49002, 12KJ49011, 12KJ49020, 12KJ49042, 12KJ49049, 12KJ49072, 12KJ49085, 12KJ49096, 12KJ49107, 12KJ49144, 12KJ49157, 12KJ49183, 12KJ49206, 12KJ49226, 12KJ49257, 12KJ49265, 12KJ49279, 12KJ49296, 12KJ49309, 12KJ49326, 12KJ49369, 12KJ49384, 12KJ49412, 12KJ49422, 12KJ49433, 12KJ49454 Class II Blood products, which did not meet the acceptable product specifications, were distributed. American Red Cross Blood Services Carolinas Region
Biologics Fresh Frozen Plasma (Apheresis) 12KJ48315 Class II Blood products, which did not meet the acceptable product specifications, were distributed. American Red Cross Blood Services Carolinas Region
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 12KJ48454, 12KJ48656, 12KJ48801, 12KJ48901, 12KJ48978, 12KJ49011 Class II Blood products, which did not meet the acceptable product specifications, were distributed. American Red Cross Blood Services Carolinas Region
Biologics Source Plasma 4150297715; 4150294349; 4150293435; 4150292493; 4150288630; 4150287719; 4150286846; 4150286095; 4150284457; 4150283934 4150282834; 4150281920; 4150280786; 4150278941; 4150277345; 4150276981; 4150275679; 4150274422; 4150274155; 4150269751 4150268915; 4150267926; 4150267061; 4150265978; 4150265356 4150264180; 4150263579; 4150262513; 4150261396; 4150259690 4150258205; 4150256705; 4150256144; 4150254565; 4150252995 4150251796; 4150251162; 4150250065; 4150248969; 4150248434 4150247203; 4150246138; 4150245557; 4150244387; 4150243771 4150242893; 4150242294; 4150240661; 4150238481; 4150237503 4150236648; 4150235331; 4150234650; 4150233857; 4150233129 4150231965; 4150223312; 4150222670; 4150221568; 4150220888 4150219778; 4150219281; 4150217819; 4150217210 Class III Donor Screening/Donor did not meet acceptance criteria Csl Plasma Inc
Biologics Source Plasma 4100357245;4100353872;4100352989;4100349565; 4100342044;4100339263;4100337890;4100335910; 4100333175;4100332154;4100330801;4100329645; 4100327628;4100326150;4100325573;4100323863; 4100323233;4100320460;4100319487;4100318146 4100317254;4100315413;4100314701;4100312805; 4100310298;4100307910;4100306851;4100305683; 4100304613;4100303660;4100302605;4100301245; 4100300337;4100295622;4100294702;4100293336; 4100292077 Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. CSL Plasma, Inc.
Biologics Red Blood Cells Leukocytes Reduced 024FJ24130; 024FJ24132; 024FJ24133; 024FJ24134; 024FJ24139; 024FJ24144; 024GL69697; 024GL69704; 024KC60837; 024KG92957; 024KG92963;024KG92978; 024KG92981; 024KG92983; 024KQ99617;024KQ99618; 024KQ99620, 024KG92580, 024KS00234, 024FL27016, 024FT14085, 024GL69657, 024GY45090, 024GY45096, 024GY45100, 024KY02545, 024KY02577, 024FJ24139, 024GK72339, 024KE82978, 024KG92974, 024KG92963, 024KP1666, 024KQ99618, 024KY02731, 024KY02732, 024KY02739, 024GP05065, 024GP05067, 024KJ12425, 024KZ65305. Class III Blood products, which may have reached an unacceptable temperature during storage, were distributed. American National Red Cross (The)
Biologics Source Plasma 3910085746,3910089389,3910081796,3910082510, 3910084270,3910084649,3910084957,3910085501, 3910085909,3910086413,3910082256,3910083028, 3910083163,3910086705,3910087030,3910088404, 3910088670,3910089156 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 3910081503, 3910081868, 3910082275, 3910082774,3910083156,3910083903,3910084951, 3910085815,3910086223,3910081900,3910082232, 3910082762,3910083137,3910083887,3910084221, 3910084617,3910084939,3910085447,3910085791, 3910086679,3910080955,3910081305,3910081712, 3910082101,3910082598,3910082906,3910085911, 3910086807,3910084747,3910085517,3910081864, 3910086960,3910082356,3910082867,3910083346, 3910083932,3910084404,3910085174,3910085487, 3910086069,3910082792,3910083133,3910084807, 3910085102,3910082281,3910083178,3910083688, 3910085520,3910085810,3910083571,3910086348, 3910080712,3910081330,3910081273,3910082149, 3910082726,3910083078,3910083587,3910083836, 3910084337,3910084447,3910085080,3910084280, 3910086049,3910078976,3910081574,3910082789, 3910083356,3910080630,3910081032,3910081705, 3910082025,3910082629,3910083021,3910084399, 3910079869,3910080355,3910080904,3910081365, 3910081708,3910082186,3910083124,3910083591, 3910083876,3910084279,3910086022,3910086341, 3910086999,3910088048,3910088078,3910088978, 3910082650,3910083064,3910083586,3910084339, 3910085083,3910083942,3910084381,3910080308, 3910080765,3910081042,3910081547,3910081879, 3910082682,3910083362,3910083708,3910084274, 3910084484,3910084967,3910085271,3910085858, 3910086140,3910082818,3910084114,3910086472, 3910085544,3910085798,3910084003,3910084266, 3910084879,3910085422,3910085762,3910086283, 3910080445,3910082380,3910081535,3910082301, 3910083062,3910083519,3910084000,3910084304, 3910084745,3910084997,3910085560,3910085886, 3910086500,3910086729,3910085208,3910085790, 3910084145,3910084571,3910085459,3910081886, 3910083546,3910084704,3910084970,3910086290, 3910084982,3910085671,3910083670,3910083913, 3910086045,3910086355,3910080168,3910080678, 3910081229,3910081480,3910082038,3910082319, 3910083132,3910083218,3910083843,3910083988, 3910084472,3910085524,3910085874,3910085359, 3910084124,3910084521,3910084834,3910079763, 3910080016,3910080417,3910081086,3910081508, 3910081999,3910082487,3910083052,3910083458, 3910083826,3910084203,3910084842,3910083262, 3910083848,3910084147,3910086494,3910084025, 3910084405,3910083981,3910084303,3910079470, 3910079842,3910083375,3910083781,3910082376, 3910083197,3910083998,3910084334,3910084830, 3910086743,3910082741,3910082907,3910083529, 3910083634,3910085393,3910086753,3910079092, 3910079828,3910081076,3910081426,3910082271, 3910082973,3910083230,3910083706,3910083945, 3910085269,3910083281,3910083917,3910085167, 3910084868,3910085216,3910085654,3910083029, 3910084824,3910081742,3910082026,3910082614, 3910082969,3910083525,3910083655,3910084281, 3910084839,3910085091,3910085670,3910085973, 3910079679,3910080273,3910080965,3910081287, 3910082042,3910082365,3910083002,3910083181, 3910083728,3910084039,3910084514,3910084773, 3910085248,3910085602,3910082954,3910083167, 3910085746,3910089389,3910081796,3910082510, 3910084270,3910084649,3910084957,3910085501, 3910085909,3910086413,3910082256,3910083028, 3910083163,3910086705,3910087030,3910088404, 3910088670,3910089156 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Talecris Plasma Resources, Inc.
Devices Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin. Lot # D101564 Class II This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". This change in thickness makes the dressing thinner, less durable and subject to tearing. The product is mislabeled. Breg Inc, An Orthofix Company
Food Stewart's Diet Orange N' Cream Soda, 12oz glass bottles Bottle Code CT101528K Class II Incorrectly placed ingredient label for non-diet beverage on bottles of diet beverage. The ingredient label incorrectly provided the ingredients for regular Stewart's Orange N' Cream Soda. The front label on the glass bottles and the 4 carrier secondary package correctly identified the product as Stewart's Diet Orange N' Cream Soda. Dr Pepper/ Seven Up, Inc
Devices Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment. Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014 Class II Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. After further examination, the user determined that the product was a 6 French Zilver Vascular Stent (part number ZIV6-35-80-10-30) rather than a 5 French size. Cook Ireland Ltd.
Biologics Red Blood Cells W363711008736 Class II Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Banco de Sangre Servicios Mutuos, Inc.
Veterinary Diamond Pet Foods, Naturals Lamb Meal & Rice Formula for Adult Dogs, Packed in 6 lb (UPC: 0 7419860995 6), 20 lb (UPC 0 7419860816 4), and 40 lb (UPC 0 7419860817 1) bags, Proudly made by Diamond Pet Food, Meta, Missouri. Product Code: DLR0101D3XALW, Best Before 04 Jan 2013 (6 lb bag); DLR0101C31XMF, Best Before 03 Jan 2013 (20 lb bag); DLR0101C31XMF, Best Before 03 Jan 3013; DLR0101C31XAG, Best Before 03 Jan 2013 and DLR0101D32XMS, Best Before 04 Jan 2013 (40 lb bags). Class I Salmonella contamination. Diamond Pet Foods
Veterinary Chicken Soup for the Dog Lovers Soul, Adult Dog Light Formula, Brand Dog Food, Net Wt 6 lb (UPC Code: 0 7419860795 2) and 35 lbs (15.87kg) bags (UPC Code: 0 7419860981 0), Proudly made by Diamond Pet Food, Meta, Missouri. Code: Production Code: CLF0102B31XCW, Best By Date: 27/JAN/2013, CLF0102B31XCW, Best By Date: 28/JAN/2013 and CLF0102B32XWR, Best By Date: 28/JAN/2013 (35 lb bags). Product Code: CLF0102B3XALW, Best by Date: 28/JAN/2013 (6 lb bags). Class I Salmonella contamination. Diamond Pet Foods
Veterinary Diamond Pet Foods, Puppy, Net Wt 6 oz samples (UPC Code: 0 7419800200 9), 8 lb (UPC Code: 0 7419800208 5), 20 lb (UPC Code: 0 7419800220 7) and 40 lb bags (UPC Code: 0 7419800240 5), Proudly made by Diamond Pet Food, Meta, Missouri. Code: Production Code: DPP0401 (6 oz samples); DPP0401B2XALW, Best By Date: 7Apr/2013 (8 lb bags); DPP0101C31XRB, Best By Date: 11/Jan/2013, DPP0101C31XME, Best By Date: 11/Jan/2013, DPP0401B22XJW, Best By Date: 6/Aprl/2013 (20 lb bags) and DPP040B2XDJ, Best By Date: 7/Apr/2013, DPP0101C31XME, Best By Date: 11/Jan/2013, DPP0401A21XAW, Best By Date: 6/Apr/2013 and DPP0401B22XJW, Best By Date: 6/Apr/2013. Class I Salmonella contamination. Diamond Pet Foods
Veterinary Purina Veterinary Diets OM Overweight Management Feline Formula, packaged in 5.5-oz. cans, UPC 38100-13810, for prescription and sale only by veterinarians. The firm name on the label is Nestle Purina Petcare Co., St. Louis, MO. Best By Jun 2013 11721159 Class I The product is deficient in thiamine (Vitamin B1) Nestle Purina PetCare Co
Devices OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same. The Optetrak Logic Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Catalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots. Class II Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification. Exactech, Inc.
Cosmetics 4 oz translucent plastic bottle of - One Black Tattoo Ink. Primary Display Panel - front of squeeze bottle is labeled as follows: "***one***Ingredients: C.I.77226; C.I.74160;***proprietary; glycerin; distilled water; alcohol Net 4 fl oz. (118.4)***Warning: This product is pure pigment. application on certain individuals may cause allergic reaction, we disclaim any responsibility for allergic reactions of certain individuals to who this pigment is applied. Spot testing or consultation with a dermatologist prior to application is urged.***Keep in Cool Dry Place Away from Extreme Heat.***Do Not Freeze- Non Toxic - Non Flammable***Keep out of the reach of childern***Dispose of in accordance to Federal, State and Local Laws***" The Secondary Display Panel - back of squeeze bottle is labeled as follows: "***Lot#***EXP***" or with "***Lot#***EXP*** Warning: This product is pure pigment. application on certain individuals may cause allergic reaction, we disclaim any responsibility for allergic reactions of certain individuals to who this pigment is applied. Spot testing or consultation with a dermatologist prior to application is urged.***Keep in Cool Dry Place Away from Extreme Heat.***Do Not Freeze- Non Toxic - Non Flammable***Keep out of the reach of childern***Dispose of in accordance to Federal, State and Local Laws***" One Black Tattoo Ink 4oz. translucent plastic bottle. Lot #'s 20110621, 20110901, 20111014, 21120104, and 20120223. Class II On 11/15/2011, Kingpin Tattoo Supply, Inc. initiated a recall for the product ONE Black Tattoo Ink (4 oz. bottle) due to lab test results finding traces of a soil based bacillus type bacteria in the ink. Kingpin Tattoo Supply, Inc.
Food Flavored cheddar cheese, vacuum packed in weights ranging from 0.25-0.50 pounds, labeled and batch coded by firm. Cheese labeled in part: "Medium Cheddar Red Pepper with Onion & Garlic Pasteurized whole milk, salt, culture, vegetable rennet, spices. r-BST free.***GOLDEN GLEN CREAMERY 15098 Field Road Bow, WA 98232***887" "887" on primary label Class I Product may be contaminated with Listeria monocytogenes. Vauxner-USA, LLC
Drugs Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UPC 7 56184 12071 2. Lot # 11338, Exp 04/13 Class II Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides. Medtech Products, Inc.
Biologics Blood and Blood Products for Reprocessing 12FR27060; Class III Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed. American National Red Cross (the)
Devices BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Lot/Exp date: 03T11346Z 2012-06-11, 03T12034 2012-07-31 Class II Leakage in Cepheid SmartCycler reaction tubes. Becton Dickinson & Co.
Devices BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. . Lot/ Exp. 03T11345ZU 2012-07-09 Class II Leakage in Cepheid SmartCycler reaction tubes. Becton Dickinson & Co.
Devices BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens fr.om patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. Lot/ Exp. 08T11248 2012-06-22, 08T11251 2012-06-26 Class II Leakage in Cepheid SmartCycler reaction tubes. Becton Dickinson & Co.
Devices BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. Lot/ Exp. 08T11250 2012-07-06 Class II Leakage in Cepheid SmartCycler reaction tubes. Becton Dickinson & Co.
Devices BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***. The BD GeneOhm VanR Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance (vanA and vanB) genes directly from perianal or rectal swabs. The BD GeneOhm VanR Assay detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated real-time PCR instrument with perianal or rectal swabs from individuals at risk for VRE colonization. The BD GeneOhm VanR Assay can be used as an aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings. The BD GeneOhm VanR Assay is not intended to diagnose VRE infections nor to guide or monitor treatment for VRE infections. Concomitant cultures are necessary to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification. Lot/ Exp. 05T11042 2012-04-30 (ONLY SOLD IN EUROPE) Class II Leakage in Cepheid SmartCycler reaction tubes. Becton Dickinson & Co.
Devices Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use. 510 k K083746 Catalog Number 1001-0320 - 22 test kits Catalog 1001-0322 - 12 test kits Class II There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Princeton Biomeditech Corp
Devices Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use. 510 k K083746 Catalog Number FLU22 Lot numbers 441A11, 441C11 Class II There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Princeton Biomeditech Corp
Devices Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use. 510 k K083746 Catalog Number 36022 Lot numbers 441H11 90 kits (22 tests per kit) Class II There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Princeton Biomeditech Corp
Devices Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light. I.D. on nameplate: FA AC3 or FA AC3000; Material #1920632, Serial #011201602557 to 011201602588; Serial #011203602617 to 011202602621; Serial #011203602676 to 011203602695; Serial #011203602756 to 011203602775; Serial #011203602776 to 011203602795; Serial #011204602798 to 011204602817; Serial #011204602861 to 011204602880; Serial #011204602970 to 011204602989; Serial #011205603032 to 011205603081; Serial #011206603118 to 011206603167; Serial #011206603168 to 011206603217; Serial #011207603303 to 011207603314; Serial #011208603316 to 011205603333; Serial #011208603361 - Serial #011209603431 to 011209603462; Serial #011210603572 to 011210603597 and Material #1851710, Serial #3705776 to 3705777 and Serial #4105778 to 4105781. Class II Cracks can arise on the welded seam on the rear joint. Trumpf Medical Systems, Inc.
Food Trader Jose's, Mild Salsa, 16 ounce (1 lb) 454g), in clear rigid plastic containers with snap on lids. SKU# 082584, UPC #00285841 Class I Products contain an ingredient (onions) that were found to be contaminated with Listeria monocytogenes. Simmering Soups Inc.
Food Trader Joe's, Balela (A savory Middle Eastern salad with chickpeas, black beans and tomatoes). 8 ounces (227g). in clear rigid plastic containers with snap on lids. SKU #068306, UPC #00683067 Class I Products contain an ingredient (onions) that were found to be contaminated with Listeria monocytogenes. Simmering Soups Inc.
Food CLIF Bar Brand Coconut Chocolate Chip CLIF Bars, 6-pack boxes, UPC: 7-22252-66030-5 Product is manufactured by Harlan Bakeries in Indianapolis, IN. Best By date: 16MAY13G1 on both carton and individual bars contained within. Class III The product contains undeclared Coconut in the ingredient statement. The Coconut Chocolate Chip bars were inadvertently placed in White Chocolate Macadamia CLIF Bar wrappers and these mislabeled bars were placed inside correctly labeled Coconut Chocolate Chip CLIF Bar boxes. Clif Bar And Company
Food CLIF Bar Brand White Chocolate Macadamia CLIF Bar, 2.4 oz (68g), Individually wrapped bars Product is manufactured by Harlan Bakeries in Indianapolis, IN. Best By date: 16MAY13G1 Class III The product contains undeclared Coconut in the ingredient statement. The Coconut Chocolate Chip bars were inadvertently placed in White Chocolate Macadamia CLIF Bar wrappers and these mislabeled bars were placed inside correctly labeled Coconut Chocolate Chip CLIF Bar boxes. Clif Bar And Company
Devices Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Lot # Expiry Date 2 Pack 76129 22 JUN 2012 77542 22 JUN 2012 78696 22 JUN 2012 80828 26 SEP 2012 80857 26 SEP 2012 81441 26 SEP 2012 82189 26 SEP 2012 83647 26 SEP 2012 84772 26 SEP 2012 86037 13 JAN 2013 86783 13 JAN 2013 88712 13 JAN 2013 90056 13 JAN 2013 91002 13 JAN 2013 93126 13 JAN 2013 6 Pack 76102 22 JUN 2012 76432 22 JUN 2012 77075 22 JUN 2012 78264 22 JUN 2012 79037 22 JUN 2012 81006 26 SEP 2012 82539 26 SEP 2012 83321 26 SEP 2012 84123 26 SEP 2012 85795 13 JAN 2013 86698 13 JAN 2013 88318 13 JAN 2013 89286 13 JAN 2013 90490 13 JAN 2013 91672 13 JAN 2013 93129 13 JAN 2013 Class II Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays Siemens Healthcare Diagnostics, Inc
Devices syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments. Version VA11B and all previously released versions. Class II When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification. QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expected. The problem is encountered under the following conditions: 1 - The QC package within the syngo(R) system is being used to evaluate QC; 2 - The syngo(R) system is configured with Multi-Rule QC, and the Multi-level option is selected without following the instructions on page 2 of the recall letter. Siemens Healthcare Diagnostics, Inc.
Food Bissinger's Campfire S'Mores Salt Caramels, packaged in 1.8-oz. boxes, 5 pieces per box, 12 boxes per display case, UPC 846107012788. The firm name on the label is Bissinger's Handcrafted Chocolatier, St. Louis, MO. Lots 000159049, 0001159168, and 0001159302. Class II The product is labeled as gluten free but contains wheat, which is listed in the ingredient statement Karl Bissinger Inc
Devices VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids. Software: Cat. 6133-30-3, Version 5.4.3. Class III Review of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of a positive signaling bottle from the VersaTREK instrument, the positive test result inadvertently reverted to a negative result in the instrument database. Trek Diagnostic Systems
Food Pine nuts, raw and shelled. Packaged in plastic bag. Labeling reads in part:"Jaffe Bros.***Organically Grown Raw, Shelled Pine Nuts This product was packaged on shared equipment that also processes Peanuts***Distributed by Jaffe Bros., Inc. P.O.Box 636 Valley Center, CA 92082***". Lot number 97638 Class II Recall was initiated after firm was informed by their supplier Specialty Commodities that a recall was initiated due to peanuts found in pine nuts. Jaffe Brothers
Food Fresh Select Brussels Sprouts, 6x8oz, 9x12oz. Item # 22986, 22707, UPC 0 11110 91610 5, 7 09351 32222 8. Code dates: A07208, A08208, Lot# 5873989, 5873990 Class II Apio Inc. is recalling brussel sprouts, broccoli-cauliflower, and snap peas because they may contain foreign material contamination of small plastic shavings from a single production line. Apio, Inc. DBA Apio Fresh LLC
Food Eat Smart Snap Peas, 14x2lbs, 6x8oz , 12x8oz. Item # 18786, 22216, 10094, UPC 7 09351 00035 5, 7 09351 00901 3 Code Dates: A07207, A08207, A07208, A08208, Lot # 5873907, 5873905, 5873906, 5874020, 5874019, 5874021. Class II Apio Inc. is recalling brussel sprouts, broccoli-cauliflower, and snap peas because they may contain foreign material contamination of small plastic shavings from a single production line. Apio, Inc. DBA Apio Fresh LLC
Food Eat Smart Broccoli & Cauliflower, 9x12oz. Item # 10068. Code Dates: B07208, B08208. UPC 7 09351 00026 3. Lot # 5873991. Class II Apio Inc. is recalling brussel sprouts, broccoli-cauliflower, and snap peas because they may contain foreign material contamination of small plastic shavings from a single production line. Apio, Inc. DBA Apio Fresh LLC
Food Blueberry Crisp CLIF Bars, 12 pack boxes, UPC: 7-22252-30260-1 Best By date 17MAR13G3 Class II A small amount of Blueberry Crisp CLIF bars were inadvertently placed in Chocolate Chip CLIF bar wrappers and placed inside correctly labeled Blueberry Crisp CLIF bar 12-pack boxes. Retailers sell to consumers in 12-pack boxes, and sometimes as individual bars. Clif Bar And Company
Food Chocolate Chip CLIF Bars, 2.4-oz (68g), individually wrapped, UPC: 7-22252-10090 Best By date 17MAR13G3 Class II A small amount of Blueberry Crisp CLIF bars were inadvertently placed in Chocolate Chip CLIF bar wrappers and placed inside correctly labeled Blueberry Crisp CLIF bar 12-pack boxes. Retailers sell to consumers in 12-pack boxes, and sometimes as individual bars. Clif Bar And Company
Devices V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists. Seria Numbers: 100026615 100029321 100029838 100030462 100030832 100026808 100029324 100029841 100030463 100030833 100026826 100029325 100029843 100030464 100030834 100027107 100029327 100029845 100030466 100030836 100027181 100029328 100029847 100030468 100030838 100027189 100029330 100030043 100030469 100030840 100027544 100029334 100030106 100030471 100030843 100027660 100029337 100030107 100030472 100030844 100027751 100029455 100030111 100030473 100030845 100027870 100029456 100030112 100030474 100030847 100027872 100029459 100030113 100030475 100030850 100027875 100029462 100030115 100030481 100030977 100028047 100029473 100030117 100030482 100030979 100028053 100029474 100030118 100030485 100030980 100028069 100029500 100030119 100030591 100030983 100028249 100029504 100030120 100030593 100030985 100028324 100029505 100030121 100030594 100030986 100028328 100029507 100030133 100030595 100030987 100028334 100029508 100030204 100030596 100030989 100028339 100029512 100030212 100030608 100030990 100028570 100029514 100030215 100030609 100030991 100028665 100029515 100030216 100030612 100030992 100028666 100029516 100030217 100030618 100030994 100028673 100029518 100030220 100030620 100030995 100029074 100029520 100030223 100030762 100030996 100029116 100029524 100030224 100030766 100030997 100029119 100029525 100030226 100030767 100030998 100029215 100029672 100030229 100030768 100031004 100029217 100029679 100030337 100030769 100031071 100029220 100029684 100030342 100030771 100031072 100029223 100029685 100030343 100030773 100031084 100029224 100029690 100030344 100030778 100031085 100029241 100029691 100030345 100030779 100031089 100029242 100029692 100030349 100030780 100031143 100029243 100029698 100030355 100030781 100031144 100029313 100029832 100030359 100030782 100031147 100029316 100029833 100030456 100030823 201002392 100029318 100029835 100030457 100030825 100029319 100029836 100030458 100030827 100029320 100029837 100030459 100030829 Class I Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilation. Respironics California Inc
Devices 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened. Product code KCT; Lot number: 60263 Class III On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators. Steris Corporation
Food Nature's Harvest, pine nuts, Net WT 3 oz (85 g), Distributed by Amport Foods, 550 Kasota Ave, SE., Minneapolis, MN 55414, 3 00 71725 72753 4. Case Label Stock No. 5640 8/3 oz Nature's Harvest, Pine Nuts Best by: 12-28-12 363x1E1, 3 00 71725 72753 5. Amport Foods Bags: Amport Foods, Pine Nuts, Net WT 4 0 z (113 g), 0 71725 70172 5, American Importing Co. Inc, Minneapolis, MN 5514. Case label: Stock No 50578 12/4 oz, Amport, Pine Nuts Best by: 03-28-13 3621F1, 1 00 71725 70172 2. Amport Foods Tubs: Pine Nuts, Net WT 4 0 z (113 g), 0 71725 71180 9, Best BY: 01-10-13 0102 MM1, Distributed by American Importing Co, INC, Minneapolis, MN 55414. Tub Case Label: Item #41130 12/4 oz, Amport Foods, Pine Nuts, Best by: 01-10-13 0102MM1, 1 00 71725 71180 6. Best By 12-28-12, 363X1E1, 08:30 (Nature's Harvest) Best By 03-28-13, 3621F1, 08:30 (Amport bags) Best By 01-10-13, 0102MM (Amport tubs) Class II Amport Foods is recalling one lot of pine nuts because there may be undeclared Peanuts present in the product. American Importing Co, Inc
Devices Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications. Model Number: HT70 and HT70 Plus. Serial numbers: N12HT700514226 to N12HT700514231, N12HT700514233 to N12HT700514236, N12HT700514238 to N12HT700614280, N12HT700614282 to N12HT700614299, N12HT700614301 to N12HT700614309, N12HT720410266 to N12HT720410268, N12HT720410271, N12HT720410273, N12HT720410282, N12HT720410283, N12HT720410286, N12HT720410288, N12HT720410289, N12HT720410290, N12HT720410294 to N12HT720510300, N12HT720510302, N12HT720510322 to N12HT720510330, N12HT720510332 to N12HT720510344, Class I May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board. Newport Medical Instruments Inc
Food intraKID Lot 658 with a Best By date of 12/12, 33 oz and 2 oz bottles Lot 658 with a Best By date of 12/12 Class II After extensive testing and investigation, Drucker Labs has determined that an incorrect form of Vitamin B3, Nicotinic Acid, was used in the manufacturing of intraKID Lot 658. This nutrient may cause a temporary symptom in a small number of consumers. This symptom, commonly known as Niacin Flush, may include itching, redness, or warmth of the skin. This typically subsides within 15  20 minutes and has no long-term side effects. Drucker Labs LP
Food Fresh Mahi Mahi Fillets,10 lb Styrofoam case, labeled in part: "***Mahi Fillets S/ON Costa Rica Wild****KEEP AT 38 OR BELOW Keep refrigerated***ATLANTIC FISHERIES 8195 NW 67TH ST MIAMI FLORIDA 33166***TEL***FAX 305-594-4301***PACK U.S.A. Sell by dates of 8/11/12, 8/13/12, and 8/14/12. Class II Atlantic Fisheries recalled 580 lbs of Mahi Mahi Fillets due to histamine levels over 50 ppm. Atlantic Fisheries
Devices AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers. Model Number MROS, Catalog #00MROS20, 00MROS21 & Model Number MRO1, Catalog #00MRO120, and 00MRO121; Model Number(s): MROS and MRO1; Serial #'s 31000 to 31079. Class II The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was installed in the water system. The incorrect fuse may result in excessive heat in the fuse holder eventually resulting in failure of the device to operate. AmeriWater Inc
Devices Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging. MRT-1503/P5-Vantage MRI System. Serial Codes: P5A0632002, P5B06Y2005, P5B0712006, P3F11Z2143. Class II The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil. Toshiba American Medical Systems Inc
Devices TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician. QED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614 Serial #s: 1002-1012, 1016-1020, and 1022. Class II On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect. Quality Electrodynamics LLC
Food Humphrey Candy Kisses, 4 oz. individually wrapped and contained in a clear plastic bag, UPC Code 81084 00002. Bags are packed 40 to a case. Dated 2-23-12 to 5-23-12 Class II On 6/5/2012 the firm voluntarily recalled their Candy Kisses due to undeclared milk on the label. The Humphrey Popcorn Co
Food Humphrey Chocolate Drizzle, 5 oz. in a clear plastic bag, UPC Code 8108400009. Bags are packed 12 to a case. Dated 2-23-12 to 5-23-12 Class II On 6/5/2012 the firm voluntarily recalled their Chocolate Drizzle Popcorn due to undeclared soy lecithin on the label. The Humphrey Popcorn Co
Devices Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. Class II The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. The dose calculation is not correctly normalized in the unusual case of preventing the optimization of segment shapes and allowing for optimization of segment Monitor Units. As a result, the dose calculation may be incorrect by a factor of 3-6. The result is always an underestimation of the dose, potentially leading to over-dosage of the patient as MU values are increased to compensate. RAYSEARCH LABORATORIES AB
Devices Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity. Catalog numbers for new systems: 5430-0076, 5430-0077, 5430-0103, and 5430-0087. Catalog numbers for conversion systems: 5430-0118 and 5430-0119. Serial numbers for new systems: 901006 through 901394, inclusive. Serial numbers for conversion systems: CNV 674 through CNV 730, inclusive. Also affected are devices which were serviced and devices for which customers received software upgrades between January 20, 2011 and June 30, 2012 with Revision 1.22, 1.23, 1.24, 1.25, or 1.26. (NOTE: Item number 5430-0075, Captus 3000 well counter system, is excluded. This system does not have the ability to perform thyroid uptake procedures.) Class II Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake protocol ?Measure Liquid and Subtract Residual." This protocol was a new feature added to Software Revision 1.22 in January 2011. The error occurs only if the user does NOT measure the residual dose immediately after measuring and administering the does. Capintec Inc
Food Dole Mushroom, packaged in a retail package, net wt. 8 oz. The UPC is 0 33383 67600 5. Code 336. Packed on Date is PO 11AUG2012. Date code is the "packed on"date and product has a 10 days shelf life with the pack on date being day one. Class I Dole 8 oz Sliced Mushrooms, product of Canada, are recalled due to potential contamination of Listeria monocytogenes. United Salad Company
Food "SAFEWAY farms White Sliced Mushrooms***DISTRIBUTED BY SAFEWAY INC.***PLEASATON, CA***PRODUCT OF CANADA***NET WT 8 OZ (227g)" UPC 0 21130 28443 6 Lot number 224S4189, UPC 0 21130 28443 6 Class I Champs 8 oz Sliced White Mushrooms are recalled due to potential contamination of Listeria monocytogenes Safeway Inc
Food Fresh Express Hearts of Romaine Crunchy and Sweet 100% Hearts of Romaine Lettuce. 10 oz. plastic bag UPC 71279 26102. Fresh Express, Salinas, CA. G222B3A; Use by August 23. Class I FDA IEH sample of Fresh Express Hearts of Romaine was found positive for Listeria Monocytogenes. Fresh Express Incorporated
Devices Siemens Mobilett Mira. Mobile X-Ray System. Model number 10273100 -- serial numbers 1034, 1038, 1041, 1042, 1043, 1053, 1057, 1070, 1079, 1081, 1088, 1098, 1099, 1102, 1103, 1105, 1106, 1107, 1108, and 1112. Class II During regular product monitoring, Siemens has become aware of a potential issue with the Mobilett Mira system. During normal clinical operation the switch on the motor drive handle of the unit may become loose and slide horizontally to the right and become trapped under the cover. This may cause the system to continuously move. In response, Siemens has issued Update Instruction XP038/12/S to replace motor drive handles and circuit board connection cables on all affected Mobilett Mira systems. Siemens Medical Solutions USA, Inc
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