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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 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,  ...
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Class II Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF 11FH01557, 11FH02075, 11FH02076, 11FH02097, 11FH02100, 11FH02131, 11FH02138, 11FH02141, 11FH02148, 11FH02149, 11FH02154, 11FH02943, 11FH02944, 11FH02950, 11FH03172, 11FH03601, 11FJ12078, 11FJ12079, 11FJ12349, 11FJ12381, 11FJ12429, 11FJ12495, 11FJ12498, 11FL23592, 11FL23594, 11FL23599, 11FL23600, 11FL23619, 11FL23621, 11FL23625, 11FL23627, 11FL23630, 11FL29150, 11FL29155, 11FL29156, 11FL29714, 11FL29716, 11FL29717, 11FL29719, 11FL29728, 11FL29730, 11FL29732, 11FL31966, 11FL31967, 11FL31968, 11FL31971, 11FL31973, 11FL31979, 11FL31980, 11FL31984,  ...
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Class II Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 11FH00941, 11FH00942, 11FH00958, 11FH00961, 11FH00963, 11FH01213, 11FH02944, 11FH02950, 11FJ11240, 11FL30632, 11FL30634, 11FL33217, 11FL33235, 11FM92804, 11FM92806, 11FM92808, 11FM93604, 11FM95400, 11FM95402, 11FM95404, 11FM95410, 11FR05111, 11FR05113, 11FR05114, 11FR07069, 11FR07071, 11FS27705, 11FS27718, 11FS27719, 11FS27998, 11FS29671, 11FS29673, 11FS29676, 11FS29677, 11FS29681, 11FS29686, 11FS29688, 11FS29689, 11FS29693, 11FS29694, 11FS30559, 11FS30561, 11FS35187, 11FT12785, 11FT12786, 11FT12788, 11FT12797, 11FT12871, 11FW14474, 11FW14775,  ...
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Class II Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 11FH00941, 11FH00942, 11FH00955, 11FH00958, 11FH00961, 11FH00963, 11FH01346, 11FH01868, 11FH01869, 11FH01876, 11FH01877, 11FH01878, 11FH03712, 11FJ10894, 11FJ10969, 11FJ11726, 11FL31438, 11FL31441, 11FL31442, 11FL31444, 11FL31448, 11FM93604, 11FM94288, 11FM94295, 11FM94301, 11FM95390, 11FM95940, 11FM95942, 11FM95943, 11FM95946, 11FM95948, 11FM95949, 11FM96243, 11FM96248, 11FM96250, 11FM97437, 11FM97440, 11FM97443, 11FM97447, 11FM97465, 11FM97473, 11FM97475, 11FM97742, 11FM97756, 11FM97757, 11FM97760, 11FM97995, 11FM97997, 11FM98001, 11FM98015,  ...
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Class II Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed. American National Red Cross (The)
Biologics Plasma, Frozen 11FM91561, 11FM93576, 11FM93581, 11FM94273, 11FM94274, 11FM94279, 11FM94280, 11FM94282, 11FM95400, 11FM95402, 11FM95404, 11FM95409, 11FM95410, 11FM97449, 11FS27703, 11FS27970, 11FS27998, 11FS27999, 11FS28002, 11FT12759, 11FW14665, 11FW16001, 11FW16611, 11FW18680, 11FW22112, 11FW22132, 11FW22135, 11FW22137, 11FW22141, 11FW22143, 11FW22155, 11FX00808, 11FZ58991, 11FZ61750, 11FZ67142, 11GG40617, 11GG40618, 11GG40621, 11GG40622, 11GJ58516, 11GJ58527, 11GJ67538, 11GL90606, 11GM81524, 11GM82611, 11GM83029, 11GM83053, 11GM84841, 11GM84842, 11GM84846,  ...
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Class II Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed. American National Red Cross (The)
Biologics Red Blood Cells, Leukoreduced, Irradiated 11FH02134, 11FL31973, 11FM93372, 11FM96945, 11FT13056, 11FW18201, 11FW23191, 11FW25678, 11FX00653, 11FX00673, 11FX00715, 11FZ65047, 11GG37388, 11GJ63708, 11GJ63709, 11GJ65929, 11GJ66619, 11GL89288, 11GL89293, 11GL89310, 11GM87065, 11GM87075, 11GN81474, 11GN81483, 11GN81490, 11GN81749, 11GR68108, 11GV68442, 11GY35394, 11GY37185, 11KF17048, 11KN06816, 11GN77230 Class II Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed. American National Red Cross (The)
Biologics Platelets, Leukocytes Reduced 11FM94273, 11FM94274, 11FM94278, 11FM94279, 11FM94280, 11FM94281, 11FM94282, 11FM94284, 11FM94288, 11FM94295, 11FM96243, 11FM96248, 11FM96250, 11FM97437, 11FM97440, 11FM97443, 11FM97447, 11FM97465, 11FM97473, 11FM97475, 11FS32637, 11FS32639, 11FS32642, 11FS32644, 11FS32646, 11FS32651, 11FT12757, 11FT12759, 11FT12779, 11FW16250, 11FW16352, 11FW16353, 11FW16358, 11FW16361, 11FW16611, 11FW17436, 11FW17438, 11FW17441, 11FW17448, 11FW17451, 11FW17453, 11FW17455, 11FW18680, 11FW18687, 11FY24514, 11FY24516, 11FY24521, 11FY24526, 11FY24532, 11FY24533,  ...
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Class II Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed. American National Red Cross (The)
Biologics Plasma Frozen, Cryoprecipitate Reduced 11FH03172, 11FJ12429, 11FJ12495, 11FL23592, 11FL23594, 11FL23599, 11FL23600, 11FL23619, 11FL23625, 11FL23630, 11FL29155, 11FL29156, 11FM92804, 11FM92806, 11FM92808, 11FM93036, 11FM93051, 11FM93347, 11FM93348, 11FM93349, 11FM93351, 11FM93353, 11FM93354, 11FM93364, 11FM93366, 11FM93368, 11FM93381, 11FM96260, 11FM96261, 11FM96263, 11FM96292, 11FM96293, 11FM96304, 11FM96307, 11FM96747, 11FM96749, 11FM96758, 11FM96761, 11FM96764, 11FM96765, 11FM96767, 11FM96770, 11FM96771, 11FM96938, 11FM96940, 11FM96941, 11FM96942, 11FM96943, 11FM96945, 11FM96947,  ...
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Class II Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated 11GS76560, 11GS76565, 11GN70854, 11GN72274, 11FW16352, 11FW16611, 11GS78518, 11GN73060, 11FM94281, 11FS32644, 11GK79417 Class II Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 11GN70827, 11FW16349, 11FW16353, 11FW16358, 11FW16361, 11FW16619, 11FY24514, 11FY24516, 11FY24521, 11FY24526, 11FY24532, 11FY24533, 11FY24534, 11FY24535, 11FY24540, 11FY24541, 11FY24544, 11GJ58516, 11GJ58527, 11GJ58548, 11GS78517, 11GS78508, 11GS78510, 11GS78530, 11GS78536, 11GS78538, 11GS78539, 11GS78544, 11GS78549, 11GS78552, 11GN73053, 11GN73056, 11GN73058, 11GN73061, 11GN73063, 11GN73086, 11GR56962, 11GR56963, 11GR56964, 11GR56965, 11GR56968, 11GR56970, 11GR56979, 11GS78652, 11GS78657, 11GS78665, 11GS78676, 11GS78677, 11GS78682, 11GS78711,  ...
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Class II Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Frozen 11GN71033 Class II Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 11FM94276 Class II Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed. American National Red Cross (The)
Biologics Source Plasma 05CIAE5431, 05CIAF0080 Class II Blood products, which were not quarantined after receiving post donation information concerning prior incarceration, were distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 4170096945, 4170096061, 4170085861, 4170085417 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. ZLB Bioplasma, Inc.
Biologics Red Blood Cells Leukocytes Reduced 01KF03482 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced W137507101405 Class III Blood product, collected from a donor with an elevated body temperature, was distributed. Lane Memorial Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced 7581341(Parts 1 and 2) Class III Blood products, which were possibly contaminated with Diptheroids, were distributed. New York Blood Center, Inc.
Biologics Source Plasma LR0215098, LR0222997, LR0224240, LR0224594, LR0225469, LR0225667, LR0230265, LR0234059, LR0234404, LR0234950, LR0235270, LR0235967, LR0236282, LR0236833, LR0237158, LR0237695, LR0237950, LR0239090, LR0239505, LR0240004, LR0240475, LR0241134, LR0241575, LR0242181, LR0242431, LR0243068, LR0243485, LR0244000, LR0252971, LR0253257, LR0253927, LR0254208, LR0254915, LR0255241, LR0256141, LR0256299, LR0256898, LR0257253, LR0257828, LR0258242, LR0258846, LR0259231, LR0259832, LR0260202, LR0260728, LR0261231, LR0261687, LR0262202, LR0262634, LR0263137,  ...
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Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. DCI Biologicals Little Rock LLC
Biologics Red Blood Cells Leukocytes Reduced 009E11831 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Fresh Frozen Plasma 009E11831 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 06GF50381 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 06GF50381 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 9093156, 9092753, 9092752, 9092751, 9092750, 9092749, 9092748, 9092368, 9092367, 9092362, 9092360, 9092357, 9092234, 9092231, 9092227, 9092106, 9092102, 9091789, 9091785, 9091784 Class III Blood products, which reached an unacceptable temperature during shipment, were distributed. Florida's Blood Centers, Inc.
Biologics Red Blood Cells 9094451, 9091555, 9085921 Class II Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed. Florida's Blood Centers, Inc.
Biologics Source Plasma 366104146, 366103699, 366096948, 366096500, 366094780, 366093173, 366092790, 366089681, 366089554, 366058810, 366058665, 366057740, 366057631, 366057233, 366057099, 366055153, 366054076, 366053858, 366053163, 366052880, 366051320, 366051080, 366050457, 366050150, 366049584, 366049370, 366046687, 366046611 Class II Blood products, collected from a donor with a history of intravenous drug use, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells 76FM27469 Class III Blood product, collected from a donor whose body temperature was not documented, was distributed. Mercy Hospital St Louis
Biologics Platelets Pheresis Leukocytes Reduced 72J200838 Class II Blood product, with a low platelet count, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 72J200513 Class II Blood product, with a low platelet count, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W11630879390500 (3 units) Class II Blood products, for which the quality control testing was not performed, were distributed. Florida Blood Services, Inc.
Biologics Source Plasma 366069850, 366072511, 366077373 Class II Blood products, collected from a donor with a history of incarceration, were distributed. Talecris Plasma Resources, Inc.
Biologics Fresh Frozen Plasma 6333195 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Florida's Blood Centers, Inc.
Biologics Source Plasma 366056293, 366056318, 366085316 Class II Blood products, collected from a donor with a history of intravenous drug use, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 366095677, 366094688, 366109073, 366107543, 366107315, 366106233, 366106003, 366104771, 366104526, 366102976, 366102501, 366101455, 366100945, 366100044, 366099310, 366098093, 366097216, 366096086 366094109, 366092688, 366091966, 366090927, 366090559, 366089066, 366088579, 366082046, 366081661, 366080530, 366080016, 366077973, 366077659, 366075300, 366072799 Class II Blood products, collected from a donor with a history of hepatitis, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma I52056587, I52056623, I52058423, I52060172, 366039929, 366046528, 366048801, 366049748, 366050083, 366051209, 366052441, 366052751, 366053373, 366053709, 366055716, 366057218, 366056696, 366057880, 366058229, 366059229, 366061240, 366061493, 366071160 Class II Blood products, collected from a donor who may have received a piercing within 12 months of donation, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 366000991, 366005544, 366008266, 366008731, 366009103, 366009671, 366010025, 366013699, 366014876, 366015158, 366017393, 366017691, 366018363, 366020303, 366020669, 366023789, 366025305, 366025629, 366027257, 366046828, 366046841, 366050624, 366050914, 366052261, 366052913, 366053174, 366053818, 366057036, 366057382, 366057888, 366058440, 366061219, 366062422, 366065707, 366065872, 366066685, 366066921, 366067657, 366070287, 366074385, 366094167, 366096751, 366097578, 366101130, 366102652 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 366110839, 366110625, 366109647, 366109272, 366106529, 366106118, 366105009, 366104617, 366103734, 366102863, 366099589, 366098121, 366097683, 366096390, 366094812, 366094325, 366092732, 366091927, 366091241, 366090522, 366088549, 366088087, 366086766, 366086560, 366084873, 366084732, 366083204, 366082379, 366081382, 366081043, 366080100, 366079694, 366077702, 366077317, 366078024, 366076637, 366075217, 366074568, 366073986, 366073459, 366072235, 366071810, 366070249, 366069409, 366068692, 366068418, 366067301, 366066951, 366066312, 366065802,  ...
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Class II Blood products, collected from a donor with a history of high-risk behavior, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 08MMTA9682, 08MMTB0851, 08MMTB1337, 08MMTB2193, 08MMTB2754, 08MMTB4201, 08MMTB4806, 08MMTB5684, 08MMTB7612, 08MMTC5407, 08MMTD4599, 08MMTD5282, 08MMTD7218, 08MMTD7759, 08MMTD8524, 08MMTD9118, 08MMTE0004, 08MMTE0530, 08MMTE1679, 08MMTE2222, 08MMTE3113, 08MMTE3639, 08MMTE4431, 08MMTE5000, 08MMTE5803, 08MMTE6341, 08MMTE8054, 08MMTE9039, 08MMTG0340, 08MMTG2052, 08MMTG2674, 08MMTG4548, 08MMTG5251, 08MMTG6972, 08MMTG9432, 08MMTH1559, 08MMTH2210, 08MMTH3307, 08MMTH4516, 08MMTH5036, 08MMTH6212, 08MMTC3877, 08MMTC6269, 08MMTC6741, 08MMTC7565, 08MMTC8055, 08MMTC8805, 08MMTC9297, 08MMTD0410, 08MMTD1409, 08MMTD1948, 08MMTE7732 Class II Blood products, collected from a donor whose record was incomplete, were distributed. BioLife Plasma Services L.P.
Biologics Blood and Blood Products for Reprocessing FH058601 Class II Blood product, which was labeled as negative for hepatitis B surface antigen (HBsAg), but tested positive for HBsAg, was distributed. Continental Services Group, Inc.
Biologics Blood and Blood Products for Reprocessing LQ107428 Class II Blood product, which tested positive for the human immunodeficiency virus (HIV), but was labeled as negative for HIV, was distributed. Continental Services Group, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 49KP13681, 49KP13684, 49KP13687 (2 units), 49KP13705 (2 units), 49KP13715 (2 units), 49KP13717 (3 units), 49KP13720, 49KP13724, 49KP13728, 49KP13735, 49KP13736, 49KP13738, 49KP13671 Class II Blood products, which were labeled as leukoreduced, but were collected on an apheresis machine that failed quality control testing for leukoreduction, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 49KP13657 (2 units), 49KP13659, 49KP13661 (2 units), 49KP13663 (3 units), 49KP13666 (2 units), 49KP13669 (2 units), 49KP13671, 49KP13677, 49KP13681, 49KP13684 (2 units), 49KP13687, 49KP13691, 49KP13692, 49KP13695, 49KP13699, 49KP13708 (3 units), 49KP13704 (3 units), 49KP13713, 49KP13722, 49KP13724, 49KP13726, 49KP13728, 49KP13730, 49KP13732, 49KP13736 (2 units), 49KP13739 (2 units) Class II Blood products, which were labeled as leukoreduced, but were collected on an apheresis machine that failed quality control testing for leukoreduction, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced W041110091473008, W04111009191000Z, W041110093299009, W041110093399001, W04111009340600Z, W04111008843300I, W04111008843400G, W04111008843700A, W04111008859500J, W04111008859600H, W04111009268800*, W04111009270700P, W04111010139200C, W041110101660004, W04111010194000P, W04111101618900R, W04111101712100E, W04111101782300S, W04111101872300K, W041111027386006, W04111102761400E, W04111102865200N, W041111030628008 Class II Blood products, which did not meet the minimum requirement for volume, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W04111009884300O, W041111016005001, W04111101796000A, W04111102009800N, W04111102860900T, W04111103060500M, W04111103061800C, W041111030637006 Class II Blood products, which did not meet the minimum requirement for volume, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells W223211396557 Class II Blood product, which tested positive for anti-HBc, was distributed. United States Blood Bank, Inc.
Biologics Source Plasma 5020185308, 5020177821, 5020176494, 5020175673, 5020175310, 5020173228, 5020172653, 5020171774, 5020170189, 5020170018, 5020168215, 5020167663, 5020164608, 5020164282, 5020158730, 5020158015, 5020152164, 5020151620, 5020147950, 5020140986, 5020140595, 5020137968 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Octapharma Plasma Inc
Biologics Source Plasma 5200026069, 5200026406, 5200027561, 5200027908, 5200028505, 5200028965, 5200029669, 5200030096, 5200030750, 5200034043, 5200034835, 5200035230, 5200035752, 5200036034, 5200036604, 5200036928, 5200037499, 5200037813, 5200038699, 5200039079, 5200039639 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Octapharma Plasma, Inc.
Biologics Source Plasma 5020156275, 5020157029, 5020157686, 5020158548, 5020159159, 5020160229, 5020160746, 5020161804, 5020162349, 5020162989, 5020164038, 5020164411, 5020165651, 5020165875, 5020167671, 5020171649, 5020172098, 5020172873, 5020173290, 5020174072, 5020174413, 5020175052, 5020175504, 5020176255, 5020176753, 5020177456, 5020178050 Class II Blood products, collected from a donor who was previously deferred, were distributed. Octapharma Plasma, Inc.
Biologics Red Blood Cells Leukocytes Reduced W118811574884, W118811503513, W118811573950, W118811574168, W118811573235 Class II Blood products, collected from donors who may have traveled to an area considered endemic for malaria, were distributed. The Blood Alliance, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W118811534577 (2 units) Class II Blood products, collected from donors who may have traveled to an area considered endemic for malaria, were distributed. The Blood Alliance, Inc.
Biologics Red Blood Cells W118811502204, W118811301264, W118811331295 Class II Blood products, collected from donors who may have traveled to an area considered endemic for malaria, were distributed. The Blood Alliance, Inc.
Drugs WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1002 E 5th St., Canton, SD 57013. Manufactured by Riger Natural, S. A. Mexico. All Lots Class I Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac. Brower Enterprises Inc
Biologics Red Blood Cells Leukocytes Reduced W043211091555 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043211091555 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 03KE41985 Class III Blood products, stored at unacceptable storage temperatures, were distributed. The American National Red Cross - Southern Region
Biologics Platelets Pheresis Leukocytes Reduced 003KE42042; 003KE42043; 003KE42045; 03KE41985; 03KE41986; 03KE41987; 03KE41987; 03KE42029; 03KE42030; Class III Blood products, stored at unacceptable storage temperatures, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced W036512122190 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. LifeShare Blood Centers
Biologics Blood Products - Other W117011322802L- part 1; W117011322802L- part 2 Class III Blood products, failed to meet the minimum specification for deglycerolized components, were distributed. Blood Centers of the Pacific - Irwin Center
Devices Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors. Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10 Class III Incorrect expiration date Sirtex Medical Limited
Biologics MTS Anti-IgG Cards (Catalog # MTS 084024) 08071200134 , 09061200105, 09061200107, 09061200109, 09061200111, 09061200115, 09061200119, 09061200121, 09061200124, 09061200128, 09061200129, 10041200104, 10041200111, 10041200113, 10041200115, 10041200119 Class III In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed. Micro Typing Systems, Inc.
Biologics MTS A/B/D Monoclonal and Reverse Grouping Card (Product Code MTS080515) 09131203710 Class II In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed. Micro Typing Systems, Inc.
Devices APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree 184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm - 10degree 184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm - 10degree 184016-10 Anterior Psoas Lumbar 18 x 40 x 16mm - 10degree 184008-00 Anterior Psoas Lumbar 18 x 40 x 08mm - 00degree 184010-00 Anterior Psoas Lumbar 18 x 40 x 10mm - 00degree 184012-00 Anterior Psoas Lumbar 18 x 40 x 12mm - 00degree 184014-00 Anterior Psoas Lumbar 18 x 40 x 14mm - 00degree 184016-00 Anterior Psoas Lumbar 18 x 40 x 16mm - 00degree 184510-08 Anterior Psoas Lumbar 18 x 45 x 08mm - 10degree 184510-10 Anterior Psoas Lumbar 18 x 45 x 10mm - 10degree 184512-10 Anterior Psoas Lumbar 18 x 45 x 12mm - 10degree 184514-10 Anterior Psoas Lumbar 18 x 45 x 14mm - 10degree 184516-10 Anterior Psoas Lumbar 18 x 45 x 16mm - 10degree 184510-00 Anterior Psoas Lumbar 18 x 45 x 10mm - 00degree 184512-00 Anterior Psoas Lumbar 18 x 45 x 12mm - 00degree 184514-00 Anterior Psoas Lumbar 18 x 45 x 14mm - 00degree 184516-00 Anterior Psoas Lumbar 18 x 45 x 16mm - 00degree 185008-10 Anterior Psoas Lumbar 18 x 50 x 08mm - 10degree 185010-10 Anterior Psoas Lumbar 18 x 50 x 10mm - 10degree 185012-10 Anterior Psoas Lumbar 18 x 50 x 12mm - 10degree 185014-10 Anterior Psoas Lumbar 18 x 50 x 14mm - 10degree 185016-10 Anterior Psoas Lumbar 18 x 50 x 16mm - 10degree 185008-00 Anterior Psoas Lumbar 18 x 50 x 08mm - 00degree 185010-00 Anterior Psoas Lumbar 18 x 50 x 10mm - 00degree 185012-00 Anterior Psoas Lumbar 18 x 50 x 12mm - 00degree 185014-00 Anterior Psoas Lumbar 18 x 50 x 14mm - 00degree 185016-00 Anterior Psoas Lumbar 18 x 50 x 16mm - 00degree 185508-10 Anterior Psoas Lumbar 18 x 55 x 08mm - 10degree 185510-10 Anterior Psoas Lumbar 18 x 55 x 10mm - 10degree 185512-10 Anterior Psoas Lumbar 18 x 55 x 12mm - 10degree 185514-10 Anterior Psoas Lumbar 18 x 55 x 14mm - 10degree 185516-10 Anterior Psoas Lumbar 18 x 55 x 16mm - 10degree 185508-00 Anterior Psoas Lumbar 18 x 55 x 08mm - 00degree 185510-00 Anterior Psoas Lumbar 18 x 55 x 10mm - 00degree 185512-00 Anterior Psoas Lumbar 18 x 55 x 12mm - 00degree 185514-00 Anterior Psoas Lumbar 18 x 55 x 14mm - 00degree 185516-00 Anterior Psoas Lumbar 18 x 55 x 16mm - 00degree The Eminent Spine Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. All lots are subject to this recall. Class II Spinal Solutions is recalling the APLIF system because it is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product performance failures that could cause patient harm due to implant breakage, movement, or inadequate sterilization. Spinal Solutions, LLC
Devices Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod 5.5 x 40mm BGR0050 Straight Rod 5.5 x 50mm BGR0060 Straight Rod 5.5 x 60mm BGR0070 Straight Rod 5.5 x 70mm BGR0080 Straight Rod 5.5 x 80mm BGR0090 Straight Rod 5.5 x 90mm BGR0100 Straight Rod 5.5 x 100mm BGR0110 Straight Rod 5.5 x 110mm BGR0120 Straight Rod 5.5 x 120mm BGR0130 Straight Rod 5.5 x 130mm BGR0140 Straight Rod 5.5 x 140mm BGR0150 Straight Rod 5.5 x 150mm BGR0200 Straight Rod 5.5 x 200mm BGR0300 Straight Rod 5.5 x 300mm BGR0400 Straight Rod 5.5 x 400mm BGR0500 Straight Rod 5.5 x 500mm BGS5535 5.5 x 35mm Polyaxial Screw BGS5540 5.5 x 40mm Polyaxial Screw BGS5545 5.5 x 45mm Polyaxial Screw BGS6035 6.0 x 35mm Polyaxial Screw BGS6040 6.0 x 40mm Polyaxial Screw BGS6045 6.0 x 45mm Polyaxial Screw BGS6050 6.0 x 50mm Polyaxial Screw BGS6535 6.5 x 35mm Polyaxial Screw BGS6540 6.5 x 40mm Polyaxial Screw BGS6545 6.5 x 45mm Polyaxial Screw BGS6550 6.5 x 50mm Polyaxial Screw BGS7035 7.0 x 35mm Polyaxial Screw BGS7040 7.0 x 40mm Polyaxial Screw BGS7045 7.0 x 45mm Polyaxial Screw BGS7050 7.0 x 50mm Polyaxial Screw BGS7055 7.0 x 55mm Polyaxial Screw BGS7535 7.5 x 35mm Polyaxial Screw BGS7540 7.5 x 40mm Polyaxial Screw BGS7545 7.5 x 45mm Polyaxial Screw A pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. All lots are being recalled. Class II Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product peformance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization. Orthopedic Alliance LLC
Devices Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers , Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP Model HSYS-REC-DUO-PPC Model HSYS-REC-DUO-PPC Models HSYS-RDR-D, HSYS-RDR-T Class II The firm is initiating this recall because the implied or stated indications in their labeling associated with Harmonie software have not yet been cleared by the FDA for sale in the USA. Stellate Systems
Food Assorted Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net distributed between 8/2012 and 3/1/2013. Class II Undeclared FD&C Colors Yellow #5, Yellow #6, Red #3, Red #40, Blue #1 and Blue #2. Ozone Confection & Bakers Supply Co.
Food Harvest Mix Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net distributed between 8/2012 and 3/1/2013. Class II Undeclared FD&C Colors Yellow #5, Yellow #6, Red #3, Red #40, Blue #1 Ozone Confection & Bakers Supply Co.
Food Easter Mix Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net distributed between 8/2012 and 3/1/2013. Class II Undeclared FD&C Colors Yellow #5, Yellow #6, Red #3, Red #40, Blue #1 and Blue #2. Ozone Confection & Bakers Supply Co.
Devices Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214 Lot 0312349249, Expires 12/31/2014 and Lot 0312361309, Expires 06/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015 Class II Glucose test strips reports no result message when tested Nova Biomedical Corporation
Devices Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only) Lot 0312361309, Expires 6/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015 Class II Glucose test strips reports no result message when tested Nova Biomedical Corporation
Devices Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures. Serial # 19069 19082 19065 19015 19057 19008 19005 19075 19064 19066 19078 19034 19061 19041 19081 19036 19058 16006 19151 19091 16013 19049 19073 19059 19016 0000000ME11041 19027 19062 19012 19030 16001 19097 19072 19035 19043 16014 19032 19020 19022 16004 16009 19053 16008 19093 19004 19029 19076 19050 16002 19019 19006 19038 16005 00000000VEN002 11021 0000000 VEN005 11039 11019 11001 11027 11008 11031 11028 11046 11038 11015 11045 11044 11043 11025 11018 11030 11033 11022 11026 11002 11003 11029 11032 11009 11020 11007 00000000VEN003 11010 11037 11013 11005 11041 11040 11006 00000000VEN004 11138 11220 11093 11294 11801 11228 11251 11253 11248 11209 11247 11193 11262 11214 11261 11054 11189 11092 11244 11260 11087 11255 11359 11231 11059 11237 11303 11212 11300 11417 11397 11391 11389 11232 11263 11210 11213 11208 11023 11290 11215 11091 11252 11245 11072 11219 11394 11205 11202 11225 11049 11131 11156 11242 11292 11243 11291 11102 11108 11298 11319 11250 11254 11384 11258 11257 11035 11114 000E3GT08064A6 0000E3GT09163A 0000E3GT08038A 0000INDNVC0041 0000E3GT10189A 0000E3GT09136A 11075 11430 11137 11154 11233 11052 11322 11301 11286 11078 11327 11125 11152 11387 11337 11396 11288 11147 11395 11427 11328 11450 11128 11471 11165 11424 11448 11421 11332 11203 11468 11363 11069 11127 11284 11124 11229 11297 11190 11204 11306 11061 11161 11151 11441 11067 11336 11435 11077 11191 11497 11206 11192 11211 11085 11325 11222 11392 11169 11347 11166 11050 11470 11464 11280 11469 11376 11310 11119 11501 11076 11086 11140 11366 11178 11495 11383 11352 11345 11358 11223 11183 11422 11004 11307 11107 11074 11293 11276 11270 11218 11142 11145 11060 11170 11188 11431 11088 11275 11462 11465 11117 11179 11414 11150 11149 11455 11089 11374 11056 11453 11017 11279 11146 11324 11320 11360 11371 11385 11467 11273 11266 11230 11353 11409 11349 11101 11148 11315 11410 11461 11228 11443 11123 11090 11082 11438 11287 11454 11491 11065 11080 11084 11269 11299 11130 11043 11278 11053 11070 11122 11098 11393 11024 11466 11372 11234 11180 11063 11096 11051 11485 11340 11334 11095 11490 11309 11403 11330 11194 11173 11162 11134 11277 11402 11066 11167 11172 11164 11308 11226 11426 11445 11282 11404 11196 11181 11227 11264 11267 11415 11333 11311 11185 11289 11304 11331 11412 11346 11405 11444 11369 11224 11221 11344 11439 11436 11182 11118 11449 11423 11356 11478 11494 11246 11058 11105 11100 11475 11472 11486 11201 11113 11474 11109 11296 11357 11272 11312 11159 11121 11463 11406 11487 11271 11437 11321 11216 11377 11132 11458 11133 11502 11317 11314 11064 11195 11305 11452 11492 11316 11062 11382 11055 11103 11400 11429 11432 11433 11373 11323 11342 11281 11129 11097 11368 11171 11350 11268 11481 11186 11476 11110 11388 11295 11168 11106 11425 11120 11184 11256 11157 11155 11313 11177 11335 11379 11459 11329 11217 11198 11440 11413 11187 11265 1 11338 11199 11362 11083 11200 11259 11381 11016 11380 11408 11111 11285 11135 11480 11354 11428 11401 11447 11163 11411 11416 11446 11160 11419 11384 11249 11238 11240 11141 11241 11434 11483 11456 11274 11207 11375 11035 11114 11115 11318 11339 11048 11176 16017 19098 19070 19086 19044 19083 19056 19048 19009 19040 19002 16007 19080 16020 19026 19025 19024 16019 19052 19047 19003 19007 19001 16015 19042 19100 19017 16010 16011 19063 19037 19011 19095 19092 19094 19077 19067 19039 19021 19023 19031 19084 19013 19028 19088 19046 19014 16016 19085 19068 19033 Class II GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically. GE Healthcare, LLC
Devices The Alere Cholestech LDX® high sensitivity C-Reactive Protein (hs-CRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX® high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Model Number 12-807. · Lot/Unit Codes: 274632, 281847 · Expiration date, or Expected shelf life: 5/5/13, 6/30/13 Class II The Alere Cholestech LDX® hsCRP cassette (PN 12807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hsCRP compared to a reference method or repeat testing on the same patient sample. Alere San Diego, Inc.
Devices ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. ALL from Jan 1 2010 - Corrected IFU implementation date Class II The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation. DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. ALL from Jan 1 2010 - Corrected IFU implementation date Class II The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation. DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. ALL from Jan 1 2010 - Corrected IFU implementation date Class II The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation. DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. ALL from Jan 1 2010 - Corrected IFU implementation date Class II The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation. DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. ALL from Jan 1 2010 - Corrected IFU implementation date Class II The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation. DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma. All Lot Numbers containing: GEN 38, Coating No. 0060, Expiration Date Range 03/01/13 through 07/01/13; GEN 39, Coating No. 0062, Expiration Date Range 07/01/13 through 09/01/13; GEN 40, Coating No. 0063, Expiration Date Range 10/01/13 through 12/01/13; GEN 41, Coating No. 0064, Expiration Date Range 12/01/13 through 02/01/14. [A Coating  ...
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Class II Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids. Ortho-Clinical Diagnostics
Devices Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter. CATALOG NO. B1000 - 02A1100488, 02A1100489, 02A1100490, 02A1100491, 02A1100492, 02A1101420, 02A1101421, 02A1102009, 02A1102010, 02A1102049, 02A1102050, 02A1103180, 02A1103181, 02A1103182, 02A1201862, 02A1201868, 02A1201869, 02A1201870, 02A1201871, 02A1202372, 02A1202373, 02A1202374, 02A1202376, 02A1202377, 02A1202378, 02A1202603, 02A1202632, 02A1202633, 02A1202634, 02A1202783, 02A1202784, 02A1202785, 02A1202786, 02A1202787, 02A1202788, 02A1202789, 02A1202790, 02A1202791, 02A1202792, 02A1203552, 02A1203553, 02A1203554, 02A1203555, 02A1203556, 02A1204179, 02B1100522,  ...
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Class II Sterile packaging may be compromised. Teleflex Medical
Devices AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and in selective electrode. All Instrument Serial Numbers with Software Versions 4.11 and Prior Model Numbers AU5811-01, AU5821-01, AU5831-01, AU5841-01, AU5811-02, AU5821-02, AU5831-02, AU5841-02, AU5811-03, AU5821-03, AU5831-03, AU5841-03, AU5811-04, AU5821-04, AU5831-04, AU5841-04, AU5811-06, AU5821-06, AU5831-06, AU5841-06 Part Numbers A94906, A94911, A94916, A91921 A94907, A94912, A94917, A94922 A94908, A94913, A94918, A94923 A94909, A94914, A91949, A94924 A94910, A94915, A94920, A94925 Model Numbers and Part Numbers listed above respecitively. Class II Beckman Coulter, Inc. initiated this recall because there is a software error that has the potential to cause the reporting of erroneous patient results because of misidentification by the AU5800 system. Beckman Coulter Inc.
Devices VITROS® Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum. Lot #'s 6630 expiration 2/26/2013, Lot # 6740 expiration 6/18/2013 and Lot # 6750 expiration date 6/11/2013. Class III Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration. Ortho-Clinical Diagnostics
Food Bakehouse Granola, 12 oz, 340 g, Scholar's Inn Bakehouse Granola 16 oz, 454 g All Natural, Baked locally 16oz bags: UPC: 635655005249 Best by: 3/9/13 -5/9/13 Lots 1209A, 1209B, 1209AB, 1209BB, 1210A, 1210B, 1210AB, 1210 BB, 108A, 108B, 113A, 113 B, 116A, 116B, 117A, 117B,118A, 118B, 123A, 123B, 124A, 124B, 130A, 203A, 203B, 131A, 131B, 206A, 206B, 207A, 207B, 209A, 209B, and 209C 12 oz bags: UPC 0063565507524, Best  ...
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Class II Bake House Granola, does not list the source of the unsalted butter ingredient as milk, an allergen. People who have an allergy or severe sensitivity to milk, run the risk of serious or life-threatening allergic reaction if they consume these products. SIB, Inc.
Biologics Blood and Blood Products for Reprocessing W036312583037; W036312506313 Class II Blood products, collected from a donor with risk factors for vCJD, were distributed. BloodCenter of Wisconsin, Inc
Devices NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120020, N16E120022, N16E120023, N16E120024, N16E120052, N16E120053, and N16E130002. Class II User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel. Philips And Neusoft Medical Systems Co., Ltd.
Devices NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles. Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013. Class II User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel. Philips And Neusoft Medical Systems Co., Ltd.
Devices GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration Mfg Lot or Serial # 0000CZC7105FJM000 00000CZC827NRN000 00000CZC8283V4000 0000CZC8283V47000 0000CZC8283V72001 0000CZC8283TX5001 00000000211423001 0000CZC8161XJT000 0000CZC94154WV003 0000CZC83942HL000 0000CZC8396CC9001 Class II GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may impact patient safety. On imported CT scans, Myocardial Perfusion Imaging (MPI) studies may create artifacts in attenuation corrected images. This may lead to a potential for misdiagnosis. GE Healthcare, LLC
Devices RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required. Model number: 025007 Class II A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective. Accuray Incorporated
Food all One Active Senior Multiple Vitamin & Mineral Powder dietary supplement, 30 Day Supply, 15.9 oz. canisters UPC: 0 52534 40008 5, Lot No. 170502, Use By: 01/15. Class II Product label misprinted to include claim of "No Dairy", even though milk is present in an ingredient (whey protein isolate). "Certified Vegan" is also claimed on the product label. The Supplement Facts panel and side panel discusses the presence of milk in the product. All One, Inc.
Food all One Original Formula Multiple Vitamin & Mineral Powder dietary supplement, 30 Day Supply, 15.9 oz. canisters UPC: 0 52534 20001 2, Lot No. 172801, Use By: 10/14. Class II Product label misprinted to include claim of "No Dairy", even though milk is present in an ingredient (calcium caseinate). "Certified Vegan" is also claimed on the product label. The side panel discusses the presence of milk in the product. All One, Inc.
Food Yum Nature Tahini, Net Wt. 18oz (1lb.2oz.)510g,12 jars/case UPC 0 56664 02206 3 Lot# RSMTM0312 Class III Planet Food is recalling Yum Nature Tahini because it has the potential to be contaminated with Salmonella. Planet Food
Devices Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion. CODES: HS00017 HS00366 HS00611 HS00804 HS01060 HS01256 HS01451 HS01662 HS01863 HS02024 HS02215 HS02371 HS02539 HS00018 HS00371 HS00615 HS00805 HS01061 HS01260 HS01456 HS01664 HS01872 HS02035 HS02239 HS02373 HS02542 HS00025 HS00378 HS00618 HS00806 HS01062 HS01265 HSOI459 HSOI667 HSOI875 HS02040 HS02240 HS02376 HS02545 HS00026 HS00384 HS00619 HS00807 HSOI063 HSOI269 HSOI460 HSOI671 HSOI876 HS02043  ...
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Class II Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions. Varian Medical Systems, Inc. Oncology Systems
Food Kwong Hung Seng Sauce - Thin Soy Sauce Product is packaged in bottles Net Wt 19 Fl oz - 12 bottles per case Product shipped to one consignee 3/26/12 No lot code No UPC Class III During a contracted state audit of the firm several insanitary conditions were found. These include a leaking roof and rodent activities. Some products showed evidence of filth. Royal Foods, Inc.
Food Pantai Thai Tea The tea is packaged in a foil laminated pouch Product of Thailand UPC 8 16125 0006 7 Lot code JCAL2010 Class III During a contracted state audit of the firm several insanitary conditions were found. These include a leaking roof and rodent activities. Some products showed evidence of filth. Royal Foods, Inc.
Food Cabrales Rojo Prieto Cheese, 1.9 kg or 4.1 lbs each wheel. 2 units per carton. Lot Number 113 Best By 11/11/2013 Class II In response to a FDA inspection, the firm initiated the recall because the product was found to be contaminated with Staphylococcus Aureus, E. Coli, and Alkaline Phosphatase. La Espanola Meats Inc
Food Chappaqua Crunch GF(Gluten Free) Simply Granola with Flax & Fruit , 12 ounce pouch UPC: 786516-76002 6 All Best By Dates between 10/01/13 and 11/10/13 Class I Product contains undeclared almonds Wild Blue Yonder Foods/Waugh
Food Free Form Amino Acids L-Arginine 7 L-Ornithine Complex With Alpha-Lipoic Acid, Promotes Circulation and Muscle Development, Dietary Supplement, 50 Vegetarian Capsules, Gluten Free, Serving Size 2 Capsules. Each product is produced for a specific customer with their distribution information on the label. A general label template was provided with attachment B information. Product is sold in 50 and 100 ct bottles. Lot number 412567. Class III Nexgen Pharma is recalling a certain lot of dietary supplement L-Arginine L-Ornithine Alpha Lipoic Acid Capsules due to subpotency of the Alpha Lipoic Acid ingredient. Nexgen Pharma, Inc.
Food O Organics Black Bean Enchiladas 9 oz. Best Before date of Oct 26 2013 Lot Code: S1596OCT2613A Class I Cedarlane Natural Foods is recalling one specific lot of O Organics Black Bean Enchiladas because it contains undeclared milk. Cedarlane Natural Foods Inc/Frankly Fresh Foods Inc.
Food Jasmine Brand Garlic Flavored Crackers (Krupuk Bawang), 40x250gr. JS-C3029 Class II Wira Corp. is recalling Jasmine Garlic Flavored Crackers because of undeclared colors FD& C Blue#1, FD & C Yellow # 5 , FD&C Yellow #6 and unapproved food color ingredients Ponceau 4R, E124, (Acid Red 18). Jans Enterprises Corp. dba WIRA Corp.
Drugs Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10 Lot# 3002450; exp 8/14 Class III Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets.. Mylan Pharmaceuticals Inc.
Food Meijer Essential M with Real Strawberries, 12 oz. UPC 8-86926-04565-9, Batch: 100425342; Best Before: 08/17/2013 Class II The label does not identify all ingredients including a chocolate containing soy lecithin, a potential allergen. Meijer Distribution, Inc
Drugs Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton, Distributed by: Laboratorios Norimex Co., San Diego, CA 92154, UPC 0 91965 02002 8. Lot #: 11611B0, Batch # 114039, Exp 10/14 Class II Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico. OPMX, LLC
Drugs Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle, Distributed by Laboratorios Nordimex Co., San Diego, CA 92154, UPC 0 91965 02001 1. Lot #: 11649A0, Exp 12/13 Class II Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico. OPMX, LLC
Drugs Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles. CK2003, CK2004 exp. 04/15, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994 exp. 07/15, CK3616, CK3617 exp. 04/15 Class II Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh. Sandoz Incorporated
Drugs TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 All Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 All Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 All Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 All Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 All Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 All Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 All Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 All Lots Class II Lack of Sterility Assurance Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 All Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 All Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 All Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs 17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Sterility Assurance Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 ALL Lots Class II Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Drugs GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21. Lot #: C0671212A, Exp 12/14 Class II Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level. Qualitest Pharmaceuticals
Drugs Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. Lot #: 11-185-DJ*, 11-196-DJ*, Exp 1NOV2013; * may be followed by 01 or 02 Class II Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection. Hospira Inc.
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