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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells KX17959 Class II Blood product, which were collected from a donor who traveled to malarial endemic areas, was distributed. Blood Center of Central Iowa (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 6753448 Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Community Blood Center of the Ozarks
Biologics Blood and Blood Products for Reprocessing 6753448 Class III Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells 6238785, 6238816, 6238935, 6238937 and 6238958. Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. New York Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced 6238820, 6238843, 6238848, 6238859, 6238873, 6238883 6238900, 6238913,, and 6238918. Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. New York Blood Center, Inc.
Biologics Platelets 6238918, 6238913, 6238909, 6238900, 6238820, 6238816, 6238873, 6238848 and 6238843. Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. New York Blood Center, Inc.
Biologics Fresh Frozen Plasma 6238918, 6238913, 6238900, 6238883, 6238820, 6238816, 6238859, 6238873, 6238848, 6238843. Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. New York Blood Center, Inc.
Biologics Red Blood Cells Irradiated 6238945 Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. New York Blood Center, Inc.
Biologics Plasma for Further Manufacturing 6238935, 6238909, 6238785, 6238937,6238945, 6238958 Class III Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. New York Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced 20FY02601 Class II Blood product, collected from a donor, whose screening/donor record was incomplete, was distributed. American National Red Cross
Biologics Source Plasma 05IMOA0697; 05IMOA0914; 05IMOA1311; 05IMOA1588; 05IMOA2057; 05IMOA2312; 05IMOA2669; 05IMOA2996; 05IMOA3358; 05IMOA3582; 05IMOA4007; 05IMOA4251; 05IMOA4655; 05IMOA4877; 05IMOA5269; 05IMOA5536; 05IMOA5997; 05IMOA6209; 05IMOA6648; 05IMOA6944; 05IMOA7372; 05IMOA7650; 05IMOA8410; 05IMOA9490; 05IMOA9751; 05IMOB1163; 05IMOB2262; 05IMOB2549; 05IMOB3013; 05IMOB3290; 05IMOB3698; 05IMOB3976; 05IMOB4378; 05IMOB4683 Class II Blood products, collected from a donor who received a piercing within 12 months of the donation, were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced 6625084 Class II Blood product, collected from a donor who traveled to malarial endemic areas, was distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 2026818(Part A); 2026818(Part B) Class II Blood products, which did not meet the acceptable product specifications, were distributed. Siouxland Community Blood Bank
Biologics Red Blood Cells Leukocytes Reduced Irradiated 011GF52924 Class II Blood product, collected from a donor for whom the acceptance criteria for hematocrit was not met, was distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced LT86807 Class III Blood products, collected from a donor with a history of surgery within the previous 12 months, were distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced 5828716 Class II Blood product, which was collected from a donor who traveled to malarial endemic area, was distributed. The Blood Alliance, Inc.
Biologics Red Blood Cells Leukocytes Reduced LX71193 Class II Blood product, collected from a donor possibly at increased risk for Creutzfeldt-Jakob Disease (CJD), was distributed. LifeServe Blood Center
Biologics Red Blood Cells 0301805; 0429177 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced 0328053; 0357685; 1336389; W045004001160; W045005025891; W045006037539 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Platelets 0301805; 0429177 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Fresh Frozen Plasma 0301805; 0328053; 1336389; 0429177; W045004001160 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Blood and Blood Products for Reprocessing LX73700 Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced LF41206 Class II Blood products, collected from a donor taking the drug Finasteride, were distributed. LifeServe Blood Center
Biologics Plasma Frozen LF41206 Class II Blood products, collected from a donor taking the drug Finasteride, were distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced W141608134016; W141608530989. Class II Blood products, collected from a donor who traveled to a malaria risk area, were distributed. Puget Sound Blood Center
Biologics Platelets Pooled Leukocytes Reduced Irradiated W141608530989. Class II Blood products, collected from a donor who traveled to a malaria risk area, were distributed. Puget Sound Blood Center
Biologics Red Blood Cells Leukocytes Reduced 6229009; 5790237 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Florida's Blood Centers, Inc.
Biologics Cryoprecipitated AHF, Pooled 5801688 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Florida's Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced 033GM37984; 033GM55654; 033GW23732; 033GW54331; 033GM57596; 033GM59812 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 Platelets Pooled Leukocytes Reduced 033GM57596;033GM55654 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 Fresh Frozen Plasma 033GM57596;033GW54331;033GM55654 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 Platelets Leukocytes Reduced 033GM35609 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 033GM37984 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 Platelets Pheresis Leukocytes Reduced 033FP63417P1;033FP63417P2 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 (Apheresis) Leukocytes Reduced 033FE00104B2;033FE00104B1 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 Irradiated 033GM35609 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 01Q17523 Class II Blood products, collected from a donor who was previously deferred after disclosing high risk behavior, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 01Q17523 Class II Blood products, collected from a donor who was previously deferred after disclosing high risk behavior, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 01Q17523 Class II Blood products, collected from a donor who was previously deferred after disclosing high risk behavior, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced W137508106942; W137508109801 Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed. Lane Memorial Blood Bank
Biologics Source Plasma 366062470; 366062795; 366063446; 366064187; 366064521; 366065712; 366066099; 366066772; 366067065; 366067722; 366068450; 366068703; 366076202; 366076635; 366080733; 366081890; 366083409; 366084655; 366090123; 366091038; 366091463; 366092776; 366093045; 366095359; 366095840; 366097361; 366098260; 366099750; 366100248 Class II Blood products collected from a donor whose scheduled physical exam had not been performed, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 366069668; 366069758; 366073001; 366073218; 366074209; 366074669; 366076781; 366078067; 366077956; 366078753; 366080353; 366080627; 366090190; 366090845; 366091600; 366092375; 366093080; 366094375; 366095054; 366095887; 366096690; 366097611; 366098270; 366099479; 366100192; 366100940; 366101921; 366102505; 366103910; 366104561; 366105398; 366106316; 366107116; 366107615; 366108885; 366109347; 366110249; 366110696; 366113832; 366113299; 366111436. Class III Blood products collected from a donor who was previously deferred for unsuitable lab test results, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 0330236642; 0330228719; 0330229933; 0330230273; 0330230666; 0330230927; 0330231306; 0330231587; 0330232281; 0330233802; 0330234079; 0330247656; 0330247936; 0330248371; 0330248613; 0330249830; 0330250077; 0330228457; 0330250432; 0330250747; 0330251105; 0330251416; 0330251837; 0330252104; 0330252656; 0330253001; 0330253386; 0330253625; 0330254070; 0330254320; 0330254818; 0330255188. Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Biomat USA, Inc.
Biologics Source Plasma 3600120348, 3600121505, 3600129385, 3600129718, 3600139574, 3600146318, 3600113732, 3600117142, 3600126283, 3600152097, 3600119660, 3600124449, 3600116045, 3600120474, 3600132145, 3600102052, 3600095721, 3600105293, 3600112932, 3600132236, 3600148531, 3600120847, 3600122062, 3600112244, 3600155258, 3600119135, 3600121782, 3600125587, 3600120927, 3600122148, 3600117187, 3600155155, 3600097815, 3600153052, 3600138842, 3600136407, 3600094765, 3600091611, 3600095375, 3600111704, 3600113337, 3600138703, 3600142234, 3600097002, 3600102988, 3600106695, 3600118592, 3600128348, 3600130365, 3600131373, 3600135318, 3600145493, 3600146823, 3600149882, 3600150582, 3600151080, 3600152366, 3600156452, 3600117901, 3600091830, 3600092587, 3600100044, 3600101015, 3600116439, 3600120367, 3600103963, 3600092598, 3600097557, 3600125175, 3600136473, 3600097015, 3600125356, 3600116050, 3600116397, 3600118310, 3600138308, 3600095885, 3600117228, 3600136362, 3600138772, 3600141036, 3600146379, 3600103956, 3600105814, 3600120905, 3600125564, 3600092542, 3600095855, 3600102607, 3600108741, 3600111616, 3600112907, 3600119577, 3600145347, 3600106135, 3600106100, 3600134517, 3600136519, 3600136917, 3600138107, 3600138914, 3600141122, 3600142437, 3600143653, 3600148211, 3600101905, 3600144642, 3600102113, 3600102698, 3600107586, 3600108397, 3600111707, 3600117967, 3600120379, 3600126159, 3600150784, 3600132131, 3600115000, 3600119516, 3600120192, 3600127123, 3600129590, 3600130543, 3600097260, 3600110551, 3600149304, 3600155255, 3600156090, 3600115916, 3600125290, 3600129389, 3600130277, 3600095682, 3600097806, 3600125004, 3600102629, 3600108952, 3600118750, 3600100920, 3600106232, 3600135267, 3600136385, 3600141619, 3600142442, 3600098555, 3600101546, 3600138639, 3600097809, 3600099014, 3600108691, 3600122928, 3600124088, 3600125575, 3600128563, 3600130121, 3600132186, 3600139965, 3600141189, 3600095693, 3600095984, 3600106963, 3600125170, 3600125552, 3600129829, 3600133658, 3600141105, 3600140887, 3600092549, 3600095887, 3600098964, 3600111710, 3600113253, 3600118358, 3600126382, 3600127521, 3600095280, 3600116423, 3600108933, 3600117332, 3600118630, 3600100068, 3600102138, 3600106212, 3600108946, 3600118675, 3600123243, 3600140794, 3600142054, 3600145465, 3600149354, 3600111037, 3600099386, 3600136521, 3600096075, 3600106617, 3600143607, 3600092518, 3600142479, 3600143176, 3600143755, 3600144452, 3600147693, 3600106553, 3600111073, 3600115952, 3600124495, 3600125294, 3600094831, 3600128548, 3600129564, 3600100683, 3600112268, 3600103861, 3600106899, 3600097029, 3600156100, 3600107509, 3600106254, 3600146030, 3600146685, 3600155017, 3600129683, 3600113306, 3600118662, 3600121324, 3600128294, 3600133026, 3600130130, 3600100023, 3600118386, 3600103976, 3600128280, 3600129310, 3600095904, 3600098974, 3600105996, 3600127097, 3600098719, 3600105861, 3600106070, 3600093799, 3600093046, 3600101553, 3600142305, 3600145418, 3600146162, 3600119486, 3600126396, 3600103986, 3600097993, 3600099418, 3600102040, 3600116514, 3600118407, 3600121268, 3600121773, 3600122891, 3600126141, 3600138867, 3600149770, 3600145654, 3600147064, 3600097523, 3600099434, 3600100374, 3600101428, 3600112709, 3600091820, 3600112839, 3600139195, 3600148546, 3600121501, 3600128371, 3600122169, 3600113998, 3600095806, 3600097214, 3600103014, 3600113190, 3600134592, 3600137478, 3600106552, 3600092393, 3600106959, 3600115925, 3600117974, 3600120199, 3600123718, 3600129428, 3600129764, 3600130357, 3600106196, 3600094788, 3600098714, 3600100315, 3600101382, 3600136417, 3600138818, 3600139477, 3600150033, 3600139525, 3600143743, 3600145732, 3600148110, 3600148563, 3600150474, 3600151769, 3600152229, 3600153058, 3600155495, 3600099994, 3600106134, 3600097252, 3600106666, 3600112216, 3600113788, 3600132517, 3600132928, 3600148803, 3600153857, 3600113256, 3600120806, 3600122013, 3600123178, 3600124349, 3600125485, 3600129776, 3600104155, 3600105307, 3600106936, 3600092573, 3600094329, 3600095392, 3600097605, 3600099406, 3600124129, 3600108683, 3600114341, 3600115938, 3600094866, 3600106673, 3600107210, 3600097527, 3600121328, 3600121731, 3600122521, 3600127015, 3600100319, 3600141990, 3600143420, 3600147438, 3600145871, 3600154975, 3600127105, 3600137475, 3600144331, 3600146108, 3600146896, 3600100977, 3600113301, 3600125463, 3600104211, 3600110998, 3600110004, 3600129610, 3600104104, 3600109740, 3600096510, 3600100943, 3600106115, 3600137092, 3600139389, 3600146175, 3600099118, 3600100065, 3600148798, 3600155111, 3600094811, 3600096465, 3600097255, 3600097529, 3600099880, 3600106569, 3600111080, 3600113399, 3600118664, 3600103587, 3600102194, 3600133717, 3600150758, 3600131339, 3600091581, 3600113002, 3600113340, 3600131293, 3600150456, 3600156017, 3600123153, 3600128489, 3600129693, 3600112108, 3600100827, 3600108469, 3600142042, 3600112068, 3600155279, 3600156769, 3600111135, 3600149939, 3600095362, 3600095389, 3600100009, 3600102146, 3600099050, 3600104118, 3600106446, 3600110962, 3600114969, 3600102639, 3600103021, 3600092963, 3600098846, 3600099124, 3600100819, 3600102149, 3600108275, 3600110633, 3600112249, 3600114492, 3600118394, 3600119852, 3600122728, 3600123165, 3600123910, 3600125086, 3600125596, 3600127537, 3600129608, 3600130555, 3600133004, 3600133811, 3600138320, 3600138747, 3600140579, 3600142078, 3600152359, 3600156804, 3600108990, 3600129345, 3600138591, 3600143385, 3600144709, 3600153064, 3600125030, 3600148348, 3600094817, 3600113737, 3600114950, 3600135532, 3600091872, 3600112833, 3600113177, 3600098924, 3600100918, 3600091653, 3600092603, 3600108279, 3600128194, 3600131362, 3600140823, 3600150954, 3600131367, 3600144426, 3600149573, 3600127040, 3600155961, 3600096666, 3600097808, 3600146948, 3600094621, 3600097229, 3600108957, 3600110094, 3600110643, 3600146278, 3600118627, 3600120841, 3600122041, 3600123183, 3600124377, 3600100777, 3600118607, 3600120281, 3600122033, 3600143514, 3600119494, 3600150141, 3600142205, 3600092948, 3600095029, 3600107582, 3600130530, 3600133770, 3600119640, 3600120341, 3600123905, 3600126585, 3600138889, 3600089513, 3600094034, 3600095079, 3600096095, 3600097978, 3600099000, 3600102030, 3600103020, 3600103617, 3600105833, 3600107543, 3600101016, 3600135148, 3600150644, 3600155157, 3600155979, 3600156730, 3600099376, 3600102156, 3600136835, 3600137464, 3600139140, 3600141523, 3600142207, 3600150031, 3600132662, 3600105867, 3600102674, 3600111702, 3600107616, 3600099095, 3600099397, 3600103980, 3600105873, 3600122196, 3600123347, 3600124430, 3600106030, 3600127426, 3600105887, 3600119657, 3600129878, 3600132128, 3600100801, 3600096417, 3600125501, 3600141098, 3600105262, 3600092876, 3600102042, 3600117215, 3600119292, 3600123913, 3600135628, 3600140800, 3600097288, 3600120376, 3600120769, 3600095979, 3600106266, 3600141179, 3600146169, 3600149336, 3600141085, 3600106538, 3600104212, 3600104157, 3600105920, 3600124486, 3600129681, 3600098954, 3600100042, 3600146159, 3600101743, 3600105871, 3600113268, 3600119302, 3600107129, 3600110575, 3600125010, 3600125412, 3600127222, 3600129349, 3600129675, 3600136806, 3600138011, 3600138621, 3600140891, 3600141472, 3600102070, 3600096077, 3600106405, 3600107504, 3600110072, 3600097606, 3600107211, 3600118766, 3600124442, 3600129581, 3600131747, 3600132432, 3600143561, 3600144844, 3600146181, 3600147510, 3600147967, 3600123915, 3600138102, 3600093901, 3600111089, 3600123318, 3600121462, 3600095869, 3600151752, 3600108963, 3600118604, 3600122036, 3600123204, 3600125498, 3600112796, 3600118481, 3600124053, 3600138820, 3600143051, 3600128224, 3600132440, 3600137113, 3600147575, 3600099407, 3600110063, 3600111060, 3600114353, 3600114837, 3600100985, 3600122073, 3600094996, 3600105829, 3600106953, 3600104011, 3600105914, 3600110948, 3600096177, 3600146090, 3600110597, 3600117934, 3600121280, 3600124062, 3600097803, 3600153508, 3600132874, 3600135136, 3600147646, 3600129806, 3600096444, 3600099409, 3600101472, 3600108272, 3600108765, 3600113746, 3600106198, 3600122434, 3600120817, 3600124143, 3600110043, 3600125494, 3600128390, 3600092535, 3600094338, 3600096516, 3600099422, 3600112647, 3600116851, 3600117968, 3600118383, 3600119502, 3600147527, 3600102153, 3600105284, 3600096456, 3600124983, 3600102920, 3600106121, 3600107206, 3600097206, 3600118319, 3600128404, 3600102082, 3600121315, 3600127128, 3600130207, 3600131364, 3600135672, 3600141621, 3600137311, 3600127225, 3600097587, 3600093235, 3600093885, 3600094943, 3600097176, 3600100686, 3600101046, 3600103870, 3600106189, 3600118683, 3600122070, 3600122598, 3600123267, 3600124418, 3600126072, 3600128332, 3600128682, 3600124960, 3600095893, 3600096644, 3600104163, 3600093526, 3600108376, 3600114928, 3600124048, 3600125556, 3600129433, 3600100780, 3600109714, 3600100051, 3600103990, 3600118498, 3600117874, 3600124286, 3600093952, 3600094613, 3600095379, 3600106142, 3600123246, 3600124406, 3600099023, 3600100997, 3600101479, 3600103104, 3600105300, 3600107438, 3600119318, 3600103599, 3600138898, 3600113283, 3600131616, 3600145884, 3600093946, 3600095085, 3600097234, 3600100060, 3600096475, 3600111014, 3600122865, 3600124126, 3600124525, 3600129589, 3600133792, 3600136106, 3600137317, 3600139566, 3600139974, 3600141225, 3600142498, 3600143540, 3600145452, 3600147038, 3600147481, 3600148884, 3600106590, 3600107592, 3600109691, 3600125182, 3600130439, 3600139613, 3600140817, 3600141609, 3600142971, 3600096488, 3600100037, 3600106560, 3600137287, 3600149987, 3600103583, 3600139865, 3600143047, 3600127866, 3600129849, 3600135228, 3600136432, 3600138846, 3600140519, 3600137205, 3600103075, 3600140705, 3600141208, 3600118583, 3600120590, 3600128219, 3600148383, 3600135329, 3600137089, 3600141798, 3600112743, 3600122152, 3600123327, 3600127249, 3600129664, 3600148093, 3600099348, 3600092957, 3600106040, 3600111628, 3600095005, 3600097247, 3600103621, 3600129793, 36001.50690, 3600149358, 3600123236, 3600104144, 3600148186, 3600122839, 3600129699, 3600135299, 3600136443, 3600118333, 3600126081, 3600096440, 3600097627, 3600097576, 3600101548, 3600098753, 3600100724, 3600102795, 3600144338, 3600146142, 3600148859, 3600111726, 3600095018, 3600095864, 3600099416, 3600095888, 3600098622, 3600147198, 3600099070, 3600101847, 3600149087, 3600154509, 3600153195, 3600098571, 3600100935, 3600116091, 3600146294, 3600146688, 3600154599, 3600156021, 3600089455, 3600146050, 3600147506, 3600144385, 3600096421, 3600100874, 3600106034, 3600114489, 3600140978, 3600121278, 3600123037, 3600124119, 3600125541, 3600120894, 3600106041, 3600095386, 3600096477, 3600112784, 3600113391, 3600114976, 3600115978, 3600140701, 3600153151, 3600102046, 3600118666, 3600130265, 3600134819, 3600143438, 3600147028, 3600118489, 3600122913, 3600123300, 3600145843, 3600129896, 3600137237, 3600145402, 3600096434, 3600097153, 3600119505, 3600136301, 3600149348, 3600149850, 3600132961, 3600092971, 3600091605, 3600132240, 3600128589, 3600096018, 3600099080, 3600126398, 3600130274, 3600131294, 3600129399, 3600142146, 3600146701, 3600108964, 3600116069, 3600117222, 3600118302, 3600121527, 3600123095, 3600123894, 3600126090, 3600129370, 3600131322, 3600143038, 3600146130, 3600098553, 3600099841, 3600114486, 3600112666, 3600102114, 3600095694, 3600097194, 3600107502, 3600109898, 3600150878, 3600152183, 3600153023, 3600106999, 3600132228, 3600139368, 3600143792, 3600147766, 3600118387, 3600136304, 3600145444, 3600156424, 3600122173, 3600094770, 3600096999, 3600112306, 3600113424, 3600117153, 3600132193, 3600121639, 3600148163, 3600149596, 3600150124, 3600096997, 3600100006, 3600092547, 3600112007, 3600146801, 3600149875, 3600151887, 3600096136, 3600142164, 3600147170, 3600150706, 3600151390, 3600155249, 3600107558, 3600108762, 3600124394, 3600125521, 36001399Q3, 3600141151, 3600142466, 3600122140, 3600123207, 3600138875, 3600142085, 3600119510, 3600128309, 3600116220, 3600095989, 3600106512, 3600139493, 3600139830, 3600142361, 3600146396, 3600147183, 3600122012, 3600121694, 3600103899, 3600100880, 3600097822, 3600106601, 3600121345, 3600108466, 3600111621, 3600113110, 3600118695, 3600108463, 3600110997, 3600112028, 3600113296, 3600097301, 3600124134, 3600142159, 3600106143, 3600099010, 3600141212, 3600143790, 3600138615, 3600110039, 3600111042, 3600094842, 3600136558, 3600137243, 3600125472, 3600102159, 3600106243, 3600106577, 3600128406, 3600130474, 3600105884, 3600110107, 3600120898, 3600093964, 3600097292, 3600102635, 3600128410, 3600093922, 3600097802, 3600109004, 3600103603, 3600121747, 3600126146, 3600137329, 3600143543, 3600122081, 3600133652, 3600138804, 3600139851, 3600142413, 3600146334, 3600147635, 3600153159, 3600156036, 3600106392, 3600116361, 3600118617, 3600124365, 3600129796, 3600132860, 3600146064, 3600153523, 3600105288, 3600106613, 3600109947, 3600120876, 3600095070, 3600098849, 3600100758, 3600104027, 3600111064, 3600114435, 3600099813, 3600094819, 3600095910, 3600096993, 3600108926, 3600122189, 3600101562, 3600112941, 3600121444, 3600123050, 3600125353, 3600129892, 3600135199, 3600102713, 3600107624, 3600103993, 3600110477, 3600111149, 3600124196, 3600125058, 3600126111, 3600102081, 3600109750, 3600102010, 3600110592, 3600117207, 3600119665. 3600118669, 3600131346, 3600090964, 3600097057, 3600107031, 3600113727, 3600116085, 3600123289, 3600131282, 3600133702, 3600148551, 3600138789, 3600148551, 3600146683, and 3600147263 Class III Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Drugs Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA Lot number 008A, expiration date Dec 2014, UPC code 830733002016 Class I Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction Body Basics Inc
Food EphBurn 25, 90 count bottle with red capsules all lot codes, no UPC codes Class I Brand New Energy is recalling all lot codes of EphBurn 25 because it may contain ephedrine alkaloids, making it an unapproved drug. Brand New Energy, LLC
Drugs Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09. Lot # :12-160-JT*, Exp 12/01/13 Class I Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold. Hospira Inc.
Drugs Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS None Class I Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug The Menz Club, LLC
Drugs Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131; Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30 Lot P53847, Exp 01/14 Class II Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system. Teva Pharmaceuticals USA, Inc.
Devices Integra XKnife® Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment. Software Versions 5.0.1 and 5.0.2. Class II Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from XKnife using DICOM-RT. Integra LifeSciences Corp.
Devices Clinical Chemistry Phenobarbital, list number 1E08 Lot Numbers 52803UN12, 62299UN12, and 85773UN12 Class II Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however, internal testing confirmed CVs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803UN12 is now expired, it exhibited similar imprecision issues. As a precaution, future replacement lots will have reduced dating until root cause is identified and preventive measures are implemented. Abbott Laboratories, Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W037712008772; W037712008772; W037711175343; W037711175343; W037711138674; W037711138674; Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Hoxworth Blood Center UC Medical Center
Biologics Fresh Frozen Plasma (Apheresis) W036312246748 Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. BloodCenter of Wisconsin, Inc
Biologics Red Blood Cells Leukocytes Reduced W0888412535911; Class III Blood product, which label was applied to blood unit with incorrect or missing information, was distributed. Kapiolani Medical Center for Women and Children
Food Siya Green Mukwhas Net Wt. 200 gm (7 oz) Distributed by: Miami Growers, Inc. 80 Broadway, Jersey City, NJ 07306 Phone: 201-985-9322, Fax: 201-985-9569 Email: miamigrowers@yahoo.com Visit us: www.miamigrowersinc.com A Product of India All lots Class II Siya Brand Green Mukwhas contain unapproved and undeclared colors. Miami Growers Inc.
Biologics Fresh Frozen Plasma 2192852; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Platelets Irradiated 2192852; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 2192852; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Fresh Frozen Plasma W065612041135; Class III Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Bergen Comm Reg Blood Center
Biologics Red Blood Cells Leukocytes Reduced 012GE28907; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (the)
Biologics Blood and Blood Products for Reprocessing 012GE28907; 012GH80270; Class III 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 Leukocytes Reduced W141412018769; Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Meek Blood Center
Biologics Red Blood Cells Leukocytes Reduced W067312012405; Class II Blood product, collected from a donor who received a tattoo within 12 months of donation, were distributed. Coffee Memorial Blood Center
Biologics Red Blood Cells Leukocytes Reduced W045011091969; Class II Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. Community Blood Center Of Gtr KC
Drugs Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA; NDC 0409-7929-09. Lot #: 05-019-JT*, Exp 05/01/13; lot number * may be followed by 01, 90, or 91. Class I Non-Sterility: Confirmed customer complaint of product contaminated with mold. Hospira Inc.
Devices Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2. Blood sampling system used on patients requiring periodic withdrawal of blood samples. 59184554, 59187809, 59191725, 59221801, 59227844, 59238613, 59326333, 59356987, 59401041, 59222349, 59227178, 59234808, 59284693, 59328047, 59270408, 59284617, 59276238, 59401734, 59270380, 59319038, 59306624, 59390840, 59195810, 59331224, 59397181, 59291446, 59272771. Class II The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples. Edwards Lifesciences, LLC
Devices ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting. Catalog No: TR7100-L and TR7100-R Lot Code: All Class I With regard ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides. Stryker Howmedica Osteonics Corp.
Drugs Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03. Lot #s: MSA 2021A, MSA 2024A, MSA 2025A, Exp July 2014 Class III Discoloration; Product may not meet specifications for color description once reconstituted. Lupin Pharmaceuticals Inc.
Devices EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis Lots 401378, 401392, 401409, and 401416 Additional lots manufactured from 11/26/12 to 12/07/12 had a stop ship issued issued on 11/21/12 and the product was placed in quarantine (it was not distributed). This represents an additional 175 units from a total of 187 units manufactured during this time period. 12 units were used for bench testing. The lot numbers of units in quarantine are 401432, 401434, 401436, and 401441. Class II EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians. Endogastric Solutions Inc
Food Canned mushrooms, #10 cans (Brites, not labeled) Lot 11 363 A 895BD Class II Some isolated spoilage was found in this lot of #10 cans. L. K. Bowman, Incorporated
Devices ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar). part number 05060311001, 05060303001 Class II Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. Roche Diagnostics Operations, Inc.
Devices CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT"). catalog number 05530199160 Class II Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. Errors have been confirmed with the EAN 13 barcodes which should not be used for patient or operator identification. Roche Diagnostics Operations, Inc.
Devices LifeScan brand OneTouch® Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels. 2AA2G01, Exp. Date: 7-31-2014; 2AA2G02, Exp. Date: 7-31-2014; 2AA2G03, Exp. Date: 8-31-2014; 3AA2G04, Exp. Date: 12-31-2014; 3AA2G05, Exp. Date: 12-31-2014 Class II When OneTouch® Ultra and OneTouch® Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly. Lifescan Inc
Devices LifeScan brand OneTouch® Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels. 2AA2101, Exp. Date: 9-30-2014; 2AA2102, Exp. Date: 10-31-2-14 Class II When OneTouch® Ultra and OneTouch® Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly. Lifescan Inc
Devices OsteoSelect DBM Putty Product Usage: Orthopedic bone filler B100164 and B110115 Class II The firm's retesting procedure was not validated. Bacterin International, Inc.
Devices Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes. Finished Good (FG) Kit Lot# KL01009-3TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01009-12TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01233-4TI, TRUEtrack Test Strip Lot# RL3476; FG Kit Lot# KM0548TI, TRUEtrack Test Strip Lot# RM3547; FG Kit Lot# KM0645TI, TRUEtrack Test Strip Lot# RM3562; FG Lot# KM0692TI, TRUEtrack Test Strip Lot# RM3562. Class II Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range. Nipro Diagnostics, Inc.
Devices Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique. Model 280, S/N 776, S/N 706, S/N 758 Class II Distribution of an unapproved device into interstate commerce. Elana, Inc.
Devices Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application. Model #881001, Serial #s: 79916, 79932, 79933, 79935, 79936, 79937, 79939, 79940, 79943, 80071, 80914, 80916, 80925, 80926, 80928, 80932, 80939, 80963, 80965, 80977, 80979, 80994, 80995, 81004, 81006, 81008, 81010, 81026, 81027, 81028, 81034, 81035, 81036, 81039, 81063, 81065, 81076, 81079, 81081, 81085, 81089, 81097, 81098, 81108, 81110, 81117, 81119, 81127, 81130, 81132, 81133, 81150, 81153, 81154, 81160, 81161, 81163, 81165, 81169, 81172, 81173, 81174, 81175, 81178, 81179, 81182, 81183, 81184, 81187, 81189, 81190, 81192, 81194, 81196, 81200, 82001, 82002, 82003, 82004, 82006, 82007, 82008, 82009, 82010, 82011, 82012, 82013, 82014, 82015, 82016, 82017, 82018, 82019, 82020, 82021, 82022, 82023, 82024, 82025, 82026, 82027, 82028, 82029, 82030, 82031, 82032, 82033, 82034, 82035, 82036, 82037, 82038, 82050, 82051, 82052, 82053, 82054, 82055, 82056, 82057, 82058, 82059, 82060, 82061, 82062, 82063, 82064, 82065, 82066, 82067, 82068, 82069, 82070, 82071, 82072, 82073, 82074, 82084, 82086, 82087, 82088, 82089, 82090, 82091, 82092, 82095, 82097, 82098, 82099, 82100, 82101, 82102, 82103, 82104, 82105, 82106, 82107, 82108, 82109, 82110, 82112, 82116, 82118, 82120, 82121, 82123, 82125, 82126, 82128, 82129, 82130, 82131, 82132, 82133, 82138, 82142, 82143, 82144, 82146, 82148, 82201, 82202, 82203, 82236, 82238, 82240, 82241, 82250, 82251, 85005, 85006, 85007, 85008, 85009, 85010, 85011, 85014, 85025, 85026, 85027, 85028, 85029, 85031, 85032, 85033, 85040, 85041, 85042, 85043, 85044, 85046, 85047, 85049, 85050, 85066, 85067, 85068, 85069, 85080, 85081, 85082, 85083, 85084, 85086, 85088, 85090, 85096, 85103, 85104, 85105, 85106, 85107, 85108, 85110, 85117, 85141, 85143, 85144, 85145, 85149, 85164, 85165, 85167, 85168, 85169, 85170, 85171, 85172, 85174, 85175, 85176, 85177, 85178, 85179, 85180, 85213, 85214, 85215, 85216, 85217, 85218, 85219, 85238, 85239, 85243, 85244, 85245, 85246, 85247, 85248, 85249, 85250, 85252, 85253, 85254, 85255, 85257, 85260, 85296, 85299, 85300, 85302, 85305, 85306, 85307, 85308, 85309, 85312, 85315, 85316, 85317, 85319, 85320, 85322, 85329, 85330, 85332, 85333, 85334, 85335, 85337, 85338, 85355, 85373, 85475, 95001, 95007, 95008, 95009, 820001, 822002, 822003, 822004, 822005, 822009, 822017, 850004, 850015, 920003 & 950001. Class II Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with the URL PACS integration. Philips was informed that when loading a study to an analysis application while using URL PACS integration configuration, after another study was opened by a review application, the Analysis monitor is updated with the study of the current patient, but the Review monitor continues to display the study from the previous patient. If the issues were to re-occur, it could pose a risk for the patient. Philips Medical Systems (Cleveland) Inc
Devices Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions. BE 183-2 -- lot numbers P0911307, P1109307, P1117907, P1210807, P1216107, P0112208, P0203508, P0208308, P0220008, P0313608, P0503608, P0510108, P0712408, P0816308, P0911708, P1008408, P0115009, P0203009, P0313109, P0603709, P0619009, P0806309, P0903509, P0905109, P0912309, P1005709, P1107809, P1205709, P1214309, P0111410, P0210810, P0212510, P0300210, P0314310, P0400710, P0404510, P0701210, P0705410, P0715010, P0816310, P0715010R10, P0705410R10, P1001810, P1011610, P1114810, P1204810, P1207310, P0109811, P0211311, P0404611, P0504911, P0603911, P0706511, P0801811, P0811811, P0818511, P0900611, P0908411, P0917111, P1008111, P1012211, P1113911, P1207111, P0107712, P0118212, P0211712, P0308512, P0409012, P0412912, P0802012, and P0813612; BE 183-R -- P0904007, P1015407, P1118107, P1209207, P0205608, P0208208, P0415408, P0509608, P0503008, P0517408R, P1215508, P0200709, P0308109, P0614909, P0712009, P0806409, P0903309, P1101909, P1101909R10, P0303710, P0409910, P0615710, P0710710, P0714510, P0814310, P0907010, P1214710, P0208711, P0208711R11, P1214710R11, P0716411, P0718111, P0807511, P0812211, P0816111, P0819511, P0914111, P1000511, P1015011, P1217911, P0117112, P0211312, P0313612, P0605312, P0709612, and P0807812; BE183-SU -- P0914607, P1015607, P1016907, P1119007, P1201807, P1211307, P0108808, P0112408, P0203008, P0208608, P0306908, P0313508, P0404908, P0510008, P0708808, P0806508, P0915908, P1020008, P1104508, P1109108, P1211608, P0102809, P0203109, P0208109, P0214609, P0302209, P0504909, P0603609, P0617209, P0618909, P0703509, P0804609, P0812609, P1005209, P1110009, P1221709, P0104510, P0108110, P0307110, P0411910, P0603510, P0616210, P0813510, P0912310, P1000910, P1017410, P0111111, P0207611, P0209411, P0216411, P0300611, P0309411, P0515711, P0619111, P0707411, P0717311, P0804011, P0809611, P0815311, P0901611, P0905011, P0915611, P1014511, P1103511, P1112811, P1116411, P1201911, P1213511, P1216511, P0103312, P0106212, P0114112, P0207712, P0211112, P0216312, P0320512, P0402512, P0408912, P0416912, P0509212, and P0513212; BE 183 SU-12 -- no lot numbers assigned; BE 183-SUR -- P0908607, P1006707, P1010807R, P1101207, P1117507, P1117707, P1210307, P1212007, P0103208, P0110308, P0116508, P0203208, P0214908, P0221508, P0317708, P0409808, P0409908, P0418308, P0508508, P0513308, P0601308, P0606608, P0704008, P0808108, P0606608R, P0814308, P0907308, P0916208, P1011108, P1016908, P1201708, P1208508, P0102409, P0113809, P0203709, P0102409R09, P0304509, P0405109, P0413009, P0501209, P0612709, P0709109, P0803109, P0910909, P1009609, P1106609, P1111509, P1206809, P1218009, P0114410, P0203010, P0304310, P0408410, P0500610, P0509410, P0607410, P0705710, P0711810, P0500610R10, P0805110, P0903110, P0909710, P1014710, P1102910, P0104411, P0116011, P0201211, P0206711, P0211011, P0219311, P0302911, P0308311, P0312211, P0400211, P0413811, P0506511, P0605911, P0609411, P0703111, P0708011, P0807911, P0809511, P0813811, P0819311, P0901311, P0905311, P0907511, P0912211, P1002711, P1018011, P1102911, P1104011, P1110711, P1207011, P0107812, P0115812, P0208312, P0210912, P0305212, P0309312, P0315812, P0400912, P0407212, P0417012, P0601712, P0701712, and P0712412; and BE 183 SUR-12 -- P1012107, P1102507, P1116107, P0319008, P1113408, P0201409, and P0703911. Class II Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use. Instrumentation Industries Inc
Food Metal cans; labeled as containing 29 oz of pinto beans packed in water and salt UPC: 071524020034; Producty Code: PINTO LP; Best By Date: 01/03/2015; Lot Code: 3003; Time Code: All Time Codes Class II Some cans may not have been fully processed which could result in product contamination by spoilage organisms or by pathogens, which could lead to illness if consumed. La Preferida Inc
Devices VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. Intended for use in the measurement of a variety of chemistry analytes. VITROS 5,1 FS Chemistry System Serial Numbers: 34000119 through 34002273; VITROS 5,1 FS Chemistry System Refurbished Serial Numbers: 34000133, 34001240, 34000193, 34001243, 34000212, 34001248, 34000316, 34001251, 34000318, 34001274, 34000337, 34001297, 34000360, 34001311, 34000420, 34001317, 34000451, 34001345, 34000478, 34001378, 34000495, 34001389, 34000497, 34001390, 34000529, 34001396, 34000538, 34001422, 34000552, 34001472, 34000557, 34001504, 34000596, 34001569, 34000601, 34001572, 34000631, 34001589, 34000642, 34001610, 34000799, 34001633, 34000805, 34001668, 34000833, 34001809, 34000851, 34001840, 34000893, 34001850, 34000947, 34001897, 34001172, 34001218 Class II Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS® Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely. Ortho-Clinical Diagnostics
Devices VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a variety of chemistry analytes. Serial Numbers 46000108 through 46000217 Class II Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS® Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely. Ortho-Clinical Diagnostics
Devices VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes. Serial Numbers 56000118 through 56001583 Class II Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS® Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely. Ortho-Clinical Diagnostics
Devices Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product. Catalog Number KC460, SMN 10472284, lot 2KD052, exp 5/1/14 and Catalog Number KC460A, SMN 10476471, lot 2KD053, exp 5/1/14. Class II Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL. Siemens Healthcare Diagnostics, Inc.
Devices ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D. Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88766009 4/28/2013 88786009 4/28/2013 89198009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90671010 6/2/2013 92212010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92395011 8/12/2013 94660011 8/12/2013 95016011 8/12/2013 95313011 8/12/2013 Class II Negative bias in patient samples for Vitamin D Siemens Healthcare Diagnostics, Inc
Devices ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D. Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88767009 4/28/2013 88787009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90253010 6/2/2013 91934010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92396011 8/12/2013 93363011 8/12/2013 95088011 8/12/2013 Class II Negative bias in patient samples for Vitamin D Siemens Healthcare Diagnostics, Inc
Devices ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D. Lot Number: C3410 Kit Lot Number/Exp. Date: 95197A10 8/16/2013 95031A10 8/16/2013 94607A10 8/16/2013 94155A10 8/16/2013 Class II Negative bias in patient samples for Vitamin D Siemens Healthcare Diagnostics, Inc
Devices ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D. Lot Number: C3410 Kit Lot Number/Exp. Date: 95010A10 8/16/2013 Class II Negative bias in patient samples for Vitamin D Siemens Healthcare Diagnostics, Inc
Devices All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch® VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch® VerioIQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Part numbers: Verio IQ Systems Kits: 022 267-01, 022 267-01, 022 267-03; Verio IQ Starter Kits: 022 268 01, 022 268-02; Verio IQ Warranty Kits: 022 275 01, 022 275 02. All lots and serial numbers Class I The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE. Lifescan Inc
Food Ideal Protein, Sea Salt & Vinegar Ridges, 7 packets Net WT 1.4 oz (40 g) each. Total net weight 9.9 oz (280 g). Distributed by Laboratories C.O.P Inc., 60 Jean-Proulx St Gatieau QC Canada J8Z 1W1 SS & Vinegar USA Lot Numbers 10723 18821 10821 22923 10822 23021 10823 23022 10921 23023 10922 23121 10923 23122 14922 32322 15522 32323 15523 32421 15621 32422 15622 32423 15623 32521 15721 32522 15722 32523 18523 18721 18722 18723 SS & Vinegar Canada Lot Numbers 10923 28922 11021 28923 11022 29021 14521 29022 14522 29023 14523 29023 14621 14922 18323 18421 18422 18423 18521 18522 28723 28821 28822 28823 28921 Class II Dakota Specialty Milling informed Zumbro River Brand (ZRB) that they are recalling Multigrain Whole Meal Flour Blend 100 (Multigrain Flour) because of a potential contamination with fine wire pieces. This Multigrain Flour is a component in an extruded base called Whey multigrain Ridges, so these fine wire pieces could be contained in the Whey Muligrain Ridges. The fine wire is too thin to be detected by metal detection, therefore ZRB is recalling the products made with the recalled Multigrain Flour which include Sea Salt & vinegar Ridges and BBQ Ridges (USA & Canada). Zumbro River Brand, Inc
Food Ideal Protein, BBQ Ridges, 7 packets Net WT 1.4 oz (40 g) each. Total net weight 9.9 oz (280 g). Distributed by Laboratories C.O.P Inc., 60 Jean-Proulx St Gatieau QC Canada J8Z 1W1 BBQ USA Lot Numbers 10123 19023 10221 23122 10222 23123 10223 23221 10321 23222 10322 23223 10323 23321 15723 32621 15821 32622 15822 33021 15823 33022 15921 33121 15922 33122 18823 33221 18921 18922 18923 19021 19022 BBQ Canada Lot Numbers 10323 10421 10622 11622 11623 11721 19023 19121 19122 19123 19221 19222 23321 23322 23323 23421 23422 23423 Class II Dakota Specialty Milling informed Zumbro River Brand (ZRB) that they are recalling Multigrain Whole Meal Flour Blend 100 (Multigrain Flour) because of a potential contamination with fine wire pieces. This Multigrain Flour is a component in an extruded base called Whey multigrain Ridges, so these fine wire pieces could be contained in the Whey Muligrain Ridges. The fine wire is too thin to be detected by metal detection, therefore ZRB is recalling the products made with the recalled Multigrain Flour which include Sea Salt & vinegar Ridges and BBQ Ridges (USA & Canada). Zumbro River Brand, Inc
Biologics BD HLA-B27 Kit; 510(k) BK050073; Manufactured by BD Biosciences 2350 Qume Drive San Jose, CA 95131 Model number 340183; Lot numbers 3029914 and 3035581 Class III Certain lots of HLA-B27 FITC/CD3 PE reagent contained in the HLA-B27 kit, contaminated with CD4 PE, were distributed. BD Biosciences, Systems & Reagents
Devices MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). Catalog Number: 70104.8012 Cardiohelp-i. Multiple serial numbers. Class II It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHELP device. The human machine interface (HMI) is the central display of the CARDIOHELP device, where measured values, settings and alarms are displayed and adjusted/confirmed, with the exception of blood flow which is set by a separate rotary knob located at the front of the device. Maquet Cardiovascular, LLC
Devices The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane. Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629. Class II Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade. Synvasive Technology Inc
Devices Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System not available Class II The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data set while programming a bolus dose. Carefusion Corporation
Devices TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery Lot Number 12FM12182 Class II One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter). Smith & Nephew Inc
Devices Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Lot/Unit Codes: 274351A, 274351B, 274352B, 274353A, 290243A, 290244A, 290641A, 290641B, 290642A, 290643A, 290643B, 290644A, 290644B, 290645A, 290645B, 290646A, 290647A, 290648A, 293669A, 293670A, 293671A, 293672A, 293673A, 296635A, 296636A, 296637A, 296638A, 296639A, 296639B, 296640A, 296641A, 296642A, 297311B, 297313A, 297313B. Class II The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System. Alere San Diego, Inc.
Drugs Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080. Lot #: 101456, Exp 05/13; 101488, Exp 06/13: 101499, 101503, Exp 07/13; 101537, 101552, 101554, Exp 08/13; 101611, 101616, 101623, Exp 10/13; 101630, Exp 11/13; 101754, Exp 03/14 Class II Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose. Precision Dose Inc.
Devices REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants. 32-422760 ( sold as part of instrument set 32-422763 ) ZB100901,ZB110201,ZB110301,ZB110302,ZB110303, ZB110304,ZB110601,ZB110602,ZB110701,ZB111201, ZB111202,ZB120201,ZB120202,ZB120701,ZB120801, ZB120802,ZB121102,ZB121103 Class II Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could lead to part of the head becoming detached from the handle. Biomet U.K., Ltd.
Devices Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea® CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries, heart, and surrounding tissue. Serial Number EMC1112028 EMC1112027 EMC1103020 VMC1302077 VMC1202027 VMC1202028 VMC1202029 VMC1109012 MCH1006002 VMC1109008 VMC1202017 VMC1202026 VMC1202025 VMC1202032 VMC1202019 VMC1202037 VMC1202022 VMC1202023 VMC1202024 VMC1202020 VMC1202021 VMC1105013 VMC1105014 VMC1105015 VMC1109011 VMC1211048 VMC1211049 VMC1202038 VMC1211043 VMC1211044 VMC1211046 VMC1211047 VMC1211045 VMC1302064 VMC1302065 VMC1211040 VMC1302050 VMC1302051 VMC1202018 VMC1109005 VMC1302076 VMC1302075 VMC1109010 VMC1109009 VMC1202034 VMC1202031 VMC1012011 EMC1012014 EMC1012015 EMC1101016 VMC1202033 VMC1202030 EMC1203036 VMC1202015 VMC1109004 VMC1202035 VMC1111013 VMC1211041 EMC1203033 EMC1209041 EMC1203037 VMC1109006 EMC1211043 VMC1109007 EMC1211044 VMC1202039 VMC1202036 VMC1109003 VMC1211042 EMC1212047 EMC1203035 EMC1109025 EMC1203031 EMC1302049 EMC1212048 EMC1201029 EMC1212045 EMC1201030 EMC1110026 VMC1108016 EMC1107022 MCH1006011 EMC1206039 EMC1101017 MCH1006001 EMC1203034 EMC1103018 EMC1103019 EMC1107023 EMC1203032 VMC1202016 EMC1108024 EMC1209042 EMC1206038 EMC1212046 EMC1012011 VMC1201014 EMC1105021 Class II Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values may be incorrect in the Results Table under the Cardiac Analysis portion of the user interface. Vital Images, Inc.
Devices Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system. Item numbers: TUS-A300/Wl and TUS-A500/Wl Class II Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. The startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. It has been determined that this may potentially cause damage to the system. Toshiba American Medical Systems Inc
Devices SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected between the patient hoist mechanism and patient sling apparatus. The scale is not intended to be used for patient transport. Serial numbers: 1005 thru 1780, 1785 thru 1809, 1866 thru 1868 and 1870 thru 1875. Class II SR Instruments Inc. is implementing a field correction for the Joerns Healthcare Patient Lifts after they received two incident reports regarding two field failures of a tensile type load cell involving the FG3105 Patient Scale. The failures resulted in patient falls. Sr Instruments Inc
Devices EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. Serial Numbers: 5041110197 5041110198 5041110205 5041110200 5041110206 5041110203 5041110207 5041110208 5041110211 5041110210 5041110216 5041110209 5041110225 5041110220 5041110218 5041110227 5041110219 5041110229 5041110212 5041110215 5041110223 5041110224 5041110221 5041110214 5041110226 5041120061 5041120065 5041120057 5041120064 5041120059 5041120069 5041120063 5041120072 5041120074 5041120066 5041120068 5041120070 5041120073 5041120076 5041120078 5041120079 5041120075 5041120077 5041120080 5041120084 5041120092 5041120096 5041120094 5041120071 5041120086 5041120089 5041120090 5041120088 5041120093 5041120095 5041120098 5041120103 5041120101 5041120091 5041120097 5041120104 5041120062 5041120105 5041120099 5041120085 5041120102 5041120108 5041120060 5041120107 5041120100 5041120106 5041120087 5041120116 5041120114 5041120113 5041120112 5041120111 5041120081 5041120067 5041120109 5041120118 5041120123 5041120110 5041120119 5041120125 5041120126 5041120117 5041120129 5041120132 5041120115 5041120127 5041120131 5041120121 5041120122 5041120130 5041120124 5041120133 5041120139 5041120136 5041120140 5041120137 5041120138 5041120157 5041120158 5041120159 5041120160 5041120161 5041120162 5041120163 5041120164 5041120165 5041120148 5041120149 5041120152 5041120153 5041120154 5041120155 5041120151 5041120150 5041120120 5041120169 5041120168 5041120176 5041120172 5041120141 5041120156 5041120142 5041120147 5041120146 5041120171 5041120145 5041120175 5041120181 5041120170 5041120173 5041120177 5041120183 5041120180 5041120182 5041120197 5041120179 5041120178 5041120190 5041120193 5041120184 5041120191 5041120196 5041120199 5041120192 5041120201 5041120203 5041120200 5041120194 5041120174 5041120198 5041120195 5041120185 5041120213 5041120206 5041120214 5041120208 5041120209 Class II Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing. Advanced Sterilization Products
Devices Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore, Precedence SPECT/CT, Brilliance CT (6, 10,16, 16P, 40, 64, and Big Bore), Brilliance iCT, Brilliance iCT SP Class II Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated. Philips Healthcare Inc.
Devices Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment. All units of these models. Class II A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to plans created using the smallest collimators. Accuray Incorporated
Devices HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes. Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below Class II HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. All other assays run on this analyzer do have Linearity Limit Flags to alert the user to values that fall below or above the validated linearity range for each assay. Horiba Instruments, Inc dba Horiba Medical
Devices Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. unit model 8015 with software version 9.12 Class I The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached. Carefusion Corporation
Devices DeGotzen XRay unit XGenus Dental X-ray unit. 766471 Class II It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification DeGotzen
Food GERBER® Pure Water (1 Plastic Gallon) Manufactured- 2/20/13 - 3/22/13- 3.79L (1 Gallon) 1304948683, 1305048682, 1305048683, 1305148682, 1305348683, 1305648682, 1305648683, 1305748682, 1306048682, 1306348681, 1306548682, 1306648681, 1306748682, 1307048682, 1307348681 Class III An audit to the purified water supplier revealed deficiencies related to the Ozone purification system and particulates, the analytical results show that mold was found on one of the batches Nestle Puerto Rico Inc
Devices Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple interfaces for patient registration, order entry, and external billing modules. It is not intended to treat disease or administer any medicinal substances or drugs. There is no contact between device and patient. syngo(R) Workflow SLR can be used as a separate RIS, interfacing to a Hospital Information System (HIS) or Picture Archiving and Communication Systems (PACS Model numbers 10558922, 10558933 and 10558980 with software version VA31A SP1/SP2/SP3 Class II Under certain conditions, when using the Search functionality, the potential exists for the wrong patient's Interactive Documents to display when viewing a signed report in the single patient view. This can occur when the Interactive Document is viewed or auto displayed, dismissed by the user, and then a different patient and signed exam is selected in single patient view. The Notes Viewer will display Interactive Document notes for the previously selected patient. The problem is when a signed report is selected, the internal list of selected exams is not being reset. The potential for a safety issue occurs when the Radiologist selects a signed report for a patient and then selects a signed report for a different patient. If the Radiologist is performing an addend on the second signed report and bases the addend on information from the incorrect note, this could then contribute to an incorrect diagnosis if this is not recognized by the Radiologist. Furthermore, if the Radiologist creates and saves a new note, the note could be saved against the previously selected patient. Siemens Medical Solutions USA, Inc
Food Publix Deli Tri Fruit and Grain Salad with red rice, red wheat, quinoa, apricots, cranberry and raisins 12oz. In a clear plastic container. Item code 04459, UPC Code: 041415396623 Use by dates of 04/15/2013, 04/14/2013 and 04/17/2013 Class I Product may be adulterated with Listeria monocytogenes. Publix Super Markets, Inc.
Devices Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use. Models 9100CR23, all lot numbers. Class II Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers. Edwards Lifesciences, LLC
Devices Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use. Models 9100CR26, all lot numbers. Class II Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers. Edwards Lifesciences, LLC
Devices GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd. Intended to store, access and manage cardiovascular information on adult and pediatrics patients. 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SBX08100045GA SBX08400052GA SBY05510075GA SBY06230110GA SBY06240113GA SBY06470152GA SBY06480154GA SBY06490158GA SBY07360210GA SBY08230264GA SBY08390280GA SBY08390282GA SBY09080309GA SBY10300380GA SBY11100398GA LOCAL_TEAM_10 LOCAL_TEAM_11 LOCAL_TEAM_12 LOCAL_TEAM_2 LOCAL_TEAM_4 LOCAL_TEAM_5 LOCAL_TEAM_6 LOCAL_TEAM_7 LOCAL_TEAM_8 SBP05500051GA SBP05520081GA SBP06090174GA SBP06090183GA SBP06330882GA SBP07122128GA SBP07373047GA SBP07423286GA SBP08013762GA SBP08194525GA SBP08254779GA SBP09236548GA SBP07212446GA SBP07282634GA SBP07312790GA SBP07423239GA SBP07493608GA SBP08104166GA SBP09186476GA SBP09186477GA SBP09467322GA SBP09477384GA SBP09477393GA SBP09497472GA SBP10478600GA SBP10498686GA SBP11158997GA SBP11339436GA SBP11339438GA SBP11459581GA SBP06200386GA SBP08244736GA SBP06150229GA SBP06150246GA SBP07122081GA SBP07122082GA SBP07122083GA SBP07340978GA SBP10328405GA LOCAL_TEAM_27 LOCAL_TEAM_28 LOCAL_TEAM_49 SBP05520080GA SBP06180298GA SBP06210439GA SBP06280647GA SBP06280672GA SBP06371060GA SBP06491460GA SBP07021752GA SBP07041771GA SBP07041772GA SBP07041805GA SBP07071979GA SBP07383076GA SBP07493609GA SBP08114268GA SBP08214660GA SBP08375321GA SBP08485709GA SBP09116204GA SBP09186475GA SBP09477436GA SBP10248110GA SBP10258213GA SBP06340971GA SBP07403106GA SBP09146355GA SBP09357020GA SBP06511555GA SBP10278234GA SBP10398546GA SBP05520136GA SBP06511552GA SBP07061826GA SBP07362930GA SBP09186459GA SBP09356977GA SBP09397202GA SBP09427223GA SBP10107754GA SBP10288258GA SBP06521691GA SBP07453383GA SBP08244719GA SBP11038747GA LOCAL_TEAM_29 LOCAL_TEAM_43 LOCAL_TEAM_44 SBP09236555GA SBP11098884GA SBP05480037GA SBP05520122GA SBP06140217GA SBP06160267GA SBP06190362GA SBP06391136GA SBP07122132GA SBP07473532GA SBP08094018GA SBP08515917GA SBP09126285GA SBP10278228GA SBP10278231GA SBP08485713GA SBP09236564GA SBP06200383GA SBP06360995GA SBP06391131GA SBP06431209GA SBP07061866GA SBP08365258GA SBP08385461GA SBP08405486GA SBP11048794GA SBP11128953GA SBR09152475GA SBX06250014GA SBX07380027GA SBX08310050GA SBY06360131GA SBP09367089GA SBP10388516GA LOCAL_TEAM_46 SBP06140216GA SBP06160263GA SBP06190339GA SBP06210438GA SBP07081986GA SBP07122122GA SBP07453376GA SBP07473530GA SBP07483558GA SBP07493604GA SBP08104135GA SBP08124342GA SBP08365289GA SBP08385394GA SBP08385409GA SBP08415498GA SBP08445596GA SBP08475667GA SBP09026011GA SBP09086175GA SBP09086177GA SBP09086183GA SBP09116205GA SBP09126277GA SBP09477419GA SBP09497449GA SBP09497455GA SBP09497463GA SBP10067688GA SBP10077714GA SBP10077734GA SBP10248099GA SBP10248117GA SBP10378503GA SBP11128936GA Class II GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, which could result in incorrect treatment. GE Healthcare, LLC
Devices IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination. Model number 550516-05 Class II Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation. Intuitive Surgical, Inc.
Devices IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination. Model number 550650-05 (P8) Class II Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation. Intuitive Surgical, Inc.
Devices HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters. Lot numbers: 102810, 010311 and 111810. Class II Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. Transonic Systems Inc
Veterinary Messerle & Sons Dewormer Mineral. Product is Type B medicated mineral premix (dewormer), formulated to contain fendendazole. The product is labeled in parts: "***Messerle & Sons Dewormer Mineral***MEDICATED***ACTIVE DRUG INGREDIENTS Fenbendazole***4540 g/ton***Manufactured by: Wilbur-Ellis Company P.O Box 407 Clackmas, OR 97015***Net Weight 50 lbs***". MESRL003 03/2010; Lot 644370; Expiration date: September 2014 Class III Messerle & Sons Dewormer Mineral is recalled because Fenbendazole drug concentration was exceeded the AV allowed. Wilbur Ellis Co
Devices EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. Batch Numbers: 5041090177 5041090127 5041090131 5041110307 5041120049 5041120065 5041120076 5041100256 5041110157 5041120133 5040107029 5041110264 5041110265 5041110280 5041100218 5041100219 5041110018 5041110143 5041110079 5041110329 5041110212 5041120155 5041100250 5041110080 5041110174 5041110330 5041110203 5041090103 5041090110 5041100103 5041100104 5041100142 5041090184 5041090185 5041120120 5041120070 5041120073 5041120080 5040107087 5041110158 5041100189 5041100186 5041110189 5041080029 5041080063 5041120034 5041080028 5041080060 5041080064 5041100145 5041100146 5041100151 5041100268 5041120081 5040107065 5041120087 5041120116 5041110111 5041110113 5040107115 5041070037 5041110121 5041110140 5041090067 5041090167 5041090168 5041120154 5041090179 5041110177 5041110112 5041110129 5041110130 5041090069 5041110271 5041070036 5041070044 5041070045 5041090034 5041090054 5041090147 5041100192 5041090203 5041100214 5041100265 5041110186 5041110187 5041100067 5041100071 5041100079 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5041120004 5041100096 5041110263 5041110262 5041110242 5041110255 5041110259 5041120068 5041110205 5041120035 5041080058 5041110219 5041100182 5041090198 5041120213 5041120101 5041100183 5041100074 5041110016 5041110254 5041080078 5041090139 5041120112 5041100048 5041120208 5041090144 5041090140 5041090193 5041100007 5041100128 5041100138 5041100188 5041110284 5041120107 5041120131 5041120169 5041120178 5041120184 5041100180 5041120206 5041110006 5041110012 5041130010 5041130011 5041100080 5041110098 5041110100 5041120103 5041120141 5041080057 5041080065 5041080066 5041080072 5041090098 5041090100 5041090221 5041100024 5041100034 5041100092 5041100023 5041100028 5041100240 5041100243 5041100249 5041100244 5041100173 5041100245 5041100069 5041110122 5041110124 5041110125 5041110126 5041110159 5041110160 5041110256 5041100082 5041100083 5041120047 5041120048 5041120054 5041120168 5041120176 5041100210 5041110220 5041120069 5041110215 5041110221 5041110223 5041110224 5041110323 5041100012 5041100178 5041110041 5041110007 5041090106 5041090022 5041110268 5041110200 5041110023 5041130005 5041100086 5041110135 5040107109 5040107111 5040107121 5041110040 5041110026 5041110090 5041110093 5041120002 5041120006 5041110245 5041110236 5041110237 5041090174 5041090178 5041120192 5041090053 5041120110 5041120119 5041100153 5041090028 5041120194 5041120200 5041120171 5041110109 5041080027 5041090187 5041090216 5041120167 5041120063 5041120072 5041120074 5041110225 5041110270 5041120079 5041120064 5041100246 5041100247 5041110144 5041110145 5041120197 5041110015 5041110017 5041100130 5041110110 5041090138 5041100098 5041090206 5041100125 5041120005 5041100261 5041070048 5041090204 5041090210 5041090214 5041090215 5041120015 5041110038 5041110037 5041100013 5041100014 5041100037 5041100039 5041120066 5041090056 5041090058 5041120092 5041090160 5041110022 5041110028 5041110029 5041110107 5041110190 5041110324 5041100228 5041110123 5041090136 5041120003 5041110211 5041110233 5041120195 5041100254 5041080024 5041100032 5041100198 5041100200 5041100203 5041100204 5041100207 5041110199 5041120198 5041120022 5041120018 5041120210 5041120211 5041090135 5041100258 5041110077 5041110222 5041100088 5041090105 5041100090 5041070035 5041070041 5041100016 5041110021 5041090191 5041090219 5041120142 5041110192 5041090094 5041100031 5041110086 5041120040 5041100042 5041100045 5041100131 5041110197 5041110198 5041110031 5041120053 5041110070 5041120041 5041110207 5041120026 5041120027 5041090102 5041090118 5041090120 5041120038 5041120044 5041120045 5041120013 5041100227 5041090197 5041110085 5041120117 5041110230 5041110235 5041110240 5041120139 5041120212 5041100231 5041110178 5041110179 5041100073 5041110175 5041120130 5041110101 5041120126 5041090222 5041090176 5041090220 5041110133 5041120151 5041100064 5041110249 5041100006 5041100009 5041100100 5041100095 5041100094 5041100121 5041120177 5041120183 5041110248 5041110258 5041120029 5041120030 5041120031 5041100018 5041120147 5041110261 5041110267 5041110102 5041110074 5041110279 5041110320 5041110163 5041090109 5041090121 5041110081 5041110084 5041100179 5041100185 5041100187 5041110117 5041110319 5041110206 5041090188 5041090190 5041110141 5041110146 5041100226 5041110009 5041120046 5041100230 5041100229 5041110218 5041100253 5041100021 5041090107 5041110290 5041120127 5041100049 5041100050 5041100051 5041100059 5041120061 5041120215 5041120145 5041100168 5041080012 5041080019 5041090114 5041090119 5041110013 5041110132 5041110195 5041110196 5041120037 5041100060 5041100061 5041110011 5041110020 5041110025 5041090130 5041110091 5041110082 5041090018 5041120014 5041120021 5041120025 5041120028 5041100135 5041100044 5041120182 5041100070 5041100075 5041110269 5041110272 5041110275 5041100255 5041090181 5041110024 5041120143 5041120144 5041120175 5041120181 5041110209 5041110216 5040107101 5040107108 5041120085 5041120102 5041100152 5041100155 5041090089 5041090095 5041090017 5041090019 5041090020 5041090021 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5041120024 5041120136 5041120140 5041090064 5041090068 5041110241 5041120058 5041100150 5041100133 5041100134 5041100154 5041100208 5041100209 5041100201 5041100148 5041090110 5041090080 5041090208 5041090211 5041110321 5041120109 5041090115 5041090218 5041120138 5041120193 5041120077 5041110227 5041110273 5041110281 5041110317 5041110128 5041090156 5041110150 5041110156 5041110151 5041110152 5041110148 5041070038 5041080020 5041070039 5041120086 5041120089 5041120090 5041080061 5041090024 5041120009 5041120010 5041120012 5041120042 5041090124 5041090125 5041090126 5041120148 5041090217 5041100181 5041120093 5041090153 5041100195 5041100199 5041110149 5041120084 5041110087 5041120052 5041120056 5041120059 5041120216 5041130004 5041130006 5041110136 5041110137 5041110003 5041080013 5041080059 5041080069 5040107073 5041090158 5041090023 5041110083 5041120123 5041080014 5041110217 5041120095 5041120098 5041090116 5041090117 5041080079 5041110251 5041090143 5041110004 5041110008 5041110252 5041110253 5041090155 5041100149 5041100163 5041100169 5041100170 5041100172 5041090066 5041110071 5041110180 5041110234 5041110019 5041110032 5041110033 5041110034 5041110035 5041120191 5041120196 5041120121 5041120122 5041120062 5041120105 5041120157 5041120158 5041120159 5041120160 5041120161 5041120162 5041120163 5041120164 5041120165 5041100091 5041110005 5041110014 5041110036 5041110210 5041100174 5041100175 5041110194 5041110214 5041110226 5041090151 5041080074 5041080015 5041080017 5041090096 5041090103 5041100085 5041100171 5041100184 5041100159 5041100065 5041100066 5041100252 5041080067 5041120017 5041100123 5041100193 5041090183 5041090186 5041110325 5041090070 5041100033 5041090062 5041090132 5041090212 5041090213 5041100072 5041120008 5041120115 5041090122 5041090133 5041090142 5041100027 5041120118 5041110305 Class II Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly. Advanced Sterilization Products
Devices Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The femoral arterial cannulae are wire-reinforced, thin-wall cannulae. Model DIIFEMII018A, Lot 59337174 Class II Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach. Edwards Lifesciences, LLC
Devices IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis. The affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016. Class III Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results. Alere San Diego, Inc.
Food Humboldt Fog (brand) Cypress Grove Chevre, Aged Goat Milk Cheese. Packaged in 7oz (random weight) and 5 oz (random weight). Cypress Grove Chevre # 213146 7oz (random weight) Cypress Grove Chevre # 35363 5oz (random weight) Products are random (various) weight. The 7 oz is packed 6 packs per case. The 5 oz is packed 8 packs per case. The sell by dates on the product are between 12/14/12 and 04/28/13. Item numbers: 35363 (5 oz) and 213146 (7 oz) LOT #s 24694 24519 24521 24969 24709 25198 25108 25455 25229 23986 25701 27477 25616 25959 28278 27694 27798 25958 26444 26279 26555 26457 28345 26771 26911 26815 26931 26895 27140 26659 29345 27474 29451 29509 27865 29866 28435 28599 28429 28828 28974 29048 29350 28973 Class III DPI Specialty Foods has been notified that some Cypress Grove Humboldt Fog Goat Cheese was labeled with incorrect ingredients. This product is produced with pasteurized goat milk, and was labeled as containing cultured raw cow's milk. DPI Specialty Foods West, Inc.
Food Fructus Lycii (400g). Dried Medlar (Net Wt: 14.11 oz (400G). Ingredients: Dried Medlar. Distributed Exclusively By: Tristar Food Wholesale Company Inc. 115 Amity Street, Jersey City NJ 07304, USA. Product of P.R.C. UPC: 6931653102466 Item #: 60025 - Dried Medlar (Net Wt: 14.11 oz (400G). UPC: 6931653102466 Class II The product contains undeclared sulfites (as a preservative). Tristar Food Wholesale Co Inc
Devices Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement. Lots Numbers included in Recall: 1X311,01251,16325,15023,15024,1Y224,23326,0X401,26385,1Y174, 17151,0Y280,17150,22028,28114,19071,23372,23346,23504,23505, 25134,25341,2W223,2X105,26001,2W573,2W574,24348,25304, 25333,26068,26165,27015,27016,29392,PD4647 Class II Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System. Synvasive Technology Inc
Drugs Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 66675B, Exp. 10/13; b) 66852B Exp. 10/13; 67138B, Exp. 02/14 Class II Chemical contamination: emission of strong odor after package was opened.. Pfizer Inc.
Drugs Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles ( NDC 60793-851-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 66730B, 66853B, Exp. 01/14; b) 66731B, 67116B, Exp. 11/13, 66856B, Exp. 12/13; 67341B, Exp, 02/14 Class II Chemical contamination: emission of strong odor after package was opened. Pfizer Inc.
Drugs Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 66369B, Exp. 10/13; 66679B, Exp. 11/13; 66850B, Exp. 12/13; b) 66676B, 66732B, Exp. 12/13; 67136B, Exp. 03/14 Class II Chemical contamination: emission of strong odor after package was opened. Pfizer Inc.
Drugs Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 66619B, Exp. 11/13; 67010B, Exp. 01/14; b) 66733B, Exp. 11/13; 67441B, Exp. 01/14 Class II Chemical contamination: emission of strong odor after package was opened.. Pfizer Inc.
Drugs Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC 60793-854-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 66897B, Exp. 12/13; b) 67137B, Exp.02/14 Class II Chemical contamination: emission of strong odor after package was opened.. Pfizer Inc.
Drugs Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 67343B, Exp. 01/14; b) 66902B, Exp. 12/13 Class II Chemical contamination: emission of strong odor after package was opened. Pfizer Inc.
Drugs Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 66373B, Exp. 10/13; 66851B, Exp. 12/13; b)66792B, Exp. 12/13; 67349B, Exp. 03/14 Class II Chemical contamination: emission of strong odor after package was opened Pfizer Inc.
Drugs Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 67013B, Exp. 01/14; b) 66900B, Exp. 01/14 Class II Chemical contamination: emission of strong odor after package was opened. Pfizer Inc.
Drugs Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 66375B, Exp. 10/13; 66719B, Exp. 01/14; b) 66904B, Exp. 01/14 Class II Chemical contamination: emission of strong odor after package was opened. Pfizer Inc.
Drugs Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 67507B, Exp. 02/14; b) 67508B, Exp. 02/14 Class II Chemical contamination: emission of strong odor after package was opened. Pfizer Inc.
Drugs Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 66671B, Exp. 11/13; 67512B, Exp. 02/14 b) 66739B Exp. 11/13; 67513B Exp. 02/14 Class II Chemical contamination: emission of strong odor after package was opened. Pfizer Inc.
Food Little Mermaid Brand Smoked Herring. No codes. Products sold prior to 04/04/2013. Class I During an inspection by FDA, it was found that the Little Mermaid Smoked Herring and Little Mermaid Pickled Herring were uneviscerated. The firm initiated the recall due to potential for Clostridium botulinum. Little Mermaid Smokehouse
Food Little Mermaid Brand Pickled Herring. No codes. Products sold prior to 04/04/2013. Class I During an inspection by FDA, it was found that the Little Mermaid Smoked Herring and Little Mermaid Pickled Herring were uneviscerated. The firm initiated the recall due to potential for Clostridium botulinum. Little Mermaid Smokehouse
Devices ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures. 23884007, 23884008, 23884009 Class II ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed with the injection. To date, there has been no evidence or report of any air injection to a patient, injury or adverse health consequence associated with this issue. Acist Medical Systems
Devices The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. List Numbers: 13000, 13100, 13150 Class II During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion. Hospira Inc.
Devices The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. List Numbers: 13086, 13087, 13088 Class II During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion. Hospira Inc.
Drugs buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217; NDC 67767-142-30. Lot #: CC1D11A, CC1D12A, CC1D17A, CC1D18A, CD1D05A, CD1D07A, CD1D08A, CD1D14A, CD1D15A, CD1D16A, CE1D08A, Exp 03/13; CE1D03A, CE1D04A, CE1D07A, CE1D06A, CE1D05A, CE1D13A, CE1D14A, CE1D15A, Exp 04/13; CF1D01A, CE1D24A, CF1D02A, Exp 05/13; CH1D08A, CH1D09A, Exp 07/13; CJ1D01A, CH1D11A, CH1D10A, CJ1D09A, CJ1D02A, CJ1D10A Exp 08/13; CL1D05A, CL1D06A, CK1D05B, CK1D06A, Exp 10/13; CL1D08A, CM1D01A, CM1D02A, Exp 11/13 Class III Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point. Actavis South Atlantic LLC
Devices Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. The kit is used by health care providers when treating patients. Lot A2376-12307, exp 2/28/2013 and Lot A2376-12272, exp 4/30/2013 Class II The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results. Heritage Labs International LLC
Devices GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System. Serial Number 00000000321WVO 00000000353WV3 00000000000000 00000000346WV7 00000000292WW3 00000000327WV7 00000000333WV5 00000000325WV1 00000000298WV0 00000000301WV2 00000000271WV7 00000000250WV1 00000000251WV9 00000000332WV7 00000000263WV4 00000000275WV8 00000000335WV0 00000000249WV3 00000000303WV8 00000000331WV9 00000000255WV0 00000000337WV6 00000000359WV0 00000000362WV4 00000000352WV5 00000000318WV6 00000000324WV4 00000000355WV8 00000000354WV1 00000000329WV3 00000000274WV1 00000000267WV5 00000000305WV3 00000000322WV8 00000000317WV8 00000000132WV1 00000000280WV8 00000000026WV5 00000000254WV3 00000000420WV0 00000000297WV2 00000XXX299WV8 00000000257WV6 00000000357WV4 00000000253WV5 00000000339WV2 00000000265WV9 00000000252WV7 Class II As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the C-arm gantry pivot and the head section of the table, there is a risk of collision or jam when the head section of the table moves toward the C-arm gantry pivot. To date no collision or injury has been reported related to this condition. GE Healthcare, LLC
Food Trader Joe's Hummus Dip Size: 16 oz., 12 units/case, SKU 20411. Size: 7 oz, 24 units/case, SKU 15735. 16oz Sell By Dates: 04/26/13, 05/01/13, 05/03/13 7oz Sell by date: 05/01/13 Class II Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment. Two Chefs On A Roll, Inc
Food Trader Joe's Three Layer Hummus Dip 12 oz., 12 units/case, SKU 80867. Sell By Dates: 04/22/13, 04/27/13, 04/28/13, 05/02/13. Class II Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment. Two Chefs On A Roll, Inc
Food Trader Joe's Mediterranean Hummus 16 oz., 12 units/case, SKU 90642. Sell By Dates: 04/25/13, 04/29/13, 05/03/13, 05/06/13. Class II Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment. Two Chefs On A Roll, Inc
Food Trader Joe's Spicy Hummus Dip 7 oz., 24 units/case, SKU 38056. Sell By Dates: 04/30/13. Class II Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment. Two Chefs On A Roll, Inc
Food Trader Joe's Roasted Garlic Hummus Dip 7 oz., 24 units/case, SKU 20648. Sell By Dates: 04/26/13, 05/02/13. Class II Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment. Two Chefs On A Roll, Inc
Food Trader Joe's Tomato Basil Hummus Dip 7 oz., 24 units/case, SKU 21953. Sell By Dates: 04/30/13, 05/01/13. Class II Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment. Two Chefs On A Roll, Inc
Food Trader Joe's Chunky Olive Hummus 7 oz., 24 units/case, SKU 75347. Sell By Dates: 04/28/13. Class II Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment. Two Chefs On A Roll, Inc
Food Trader Joe's Mediterranean Hummus Snack Pack with Pita Chips 8 oz., 24 units/case, SKU 97136. Sell By Dates: 04/25/13, 04/26/13, 04/29/13, 05/01/13, 05/02/13, 05/03/13, 05/06/13 Class II Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment. Two Chefs On A Roll, Inc
Food Trader Joe's Hummus Salad Dressing 12 oz., 12 units/case, SKU 96752. Sell By Dates: 05/14/13, 05/18/13, 05/20/13, 05/21/13, 05/22/13, 05/25/13. Class II Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment. Two Chefs On A Roll, Inc
Devices GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. 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00000L8B2FAE2A 00000H12118001 00000P10312010 00000V11136003 00000B12048009 00000Q11340002 00000E11301001 00000F11206003 000001010024GS 00000B12048007 00000Y11013001 00000Z10335002 000001010040GS 00000B12048008 00000Q11340001 0000AM11360001 00000M12067007 00000P10347005 00000P11244008 000001010045GS 0000AM11360002 0000AX11314004 00000Q11333002 00000B12002006 00000A11096009 00000P10347010 0000AB11054003 00000Y11013009 00000M11284005 0000AD11104004 0000AD11104005 00000L7B3745A8 USE152PED2 000001010023GS Class II GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewer. GE Healthcare, LLC
Food Fresh & Easy Organic 100% Apple Juice from concentrate, 64 oz, 8 units/case. UPC/Barcode: 50513790021007 ORIN: 100012615 SPORIN: 100012623 Lot Code: 3690430491, expiration 2/18/2014. Lot Code: 3690430701, expiration 3/11/2014. Class II Fresh and Easy is recalling Fresh & Easy Organic Apple Juice because it may be contaminated with patulin. Fresh And Easy
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