• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Source Plasma 0440061470 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Biomat USA, Inc.
Biologics Source Plasma 0440060645 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Biomat USA, Inc.
Biologics Source Plasma 0440062579 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Biomat USA, Inc.
Biologics Source Plasma 0440062480 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Biomat USA, Inc.
Biologics Red Blood Cells LX51298 Class III Blood products, collected from a donor who disclosed taking Dapsone, were distributed. LifeServe Blood Center
Biologics Platelets Pooled Leukocytes Reduced LP46813 Class III Blood products, collected from a donor who disclosed taking Dapsone, were distributed. LifeServe Blood Center
Biologics Blood and Blood Products for Reprocessing LX51298 Class III Blood products, collected from a donor who disclosed taking Dapsone, were distributed. LifeServe Blood Center
Biologics Source Plasma 0630000144, 0630000390 Class II Blood products, collected from a donor who received a piercing within one year of donation, were distributed. Biomat USA, Inc.
Biologics Source Plasma 0630000313 Class II Blood product, collected from a donor who received a piercing within one year of donation, was distributed. Biomat USA, Inc.
Biologics Source Plasma 0630001318 Class II Blood product, collected from a donor who received a piercing within one year of donation, was distributed. Biomat USA, Inc.
Biologics Blood and Blood Products for Reprocessing 6702463 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Community Blood Center of the Ozarks
Biologics Source Plasma 8160052763, 8160051047, 8160050780, 8160050356, 8160048823, 8160048574, 8160046973, 8160044948, 8160044626, 8160044266, 8160044047, 8160043643, 8160043634, 8160042902, 8160042819, 8160039198, 8160039056, 8160037466, 8160036624, 8160036207, 8160034821, 8160034135, 8160033992, 8160033693, 8160033432, 8160032439 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. Biomat USA, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W141608084774 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Puget Sound Blood Center
Biologics Source Plasma 0420047676, 0420047864, 0420049894, 0420058168 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. Biomat USA, Inc.
Biologics Source Plasma I52016184, I52016394, I52018262, I52018570, I52018970, I52019242, I52019495, I52019724, I52022606, I52020929, I52021091, I52021531, I52021688 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells W141608653413 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Puget Sound Blood Center and Program
Biologics Platelets Pooled W141608253881 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Puget Sound Blood Center and Program
Biologics Red Blood Cells Leukocytes Reduced Irradiated W141608253881 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Puget Sound Blood Center and Program
Biologics Source Plasma 366114186, 366112717, 366111503, 366113827, 366110539, 366110229, 366109212, 366102779, 366101468, 366100729, 366099619, 366098290, 366096881, 366096418, 366094371, 366093295, 366091439, 366091305, 366087915, 366087494, 366086570, 366084819, 366084594, 366083584, 366083319, 366081603, 366081414, 366080176, 366079795, 366077808, 366077428, 366076904, 366075364, 366074966, 366074174, 366073803, 366073008, 366072170, 366071460, 366071145, 366070369, 366068705, 366068050, 366067625, 366065135, 366065088, 366049285, 366048534, 366048220, 366047767, 366046406, 366045572, 366044844, 366044738, 366043964, 366043723, 366043313, 366042910, 366042564, 366041779, 366041598, 366040691, 366040325, 366039315, 366038536, 366037633, 366037133, 366036815, 366036174, 366036017, 366034409, 366034140, 366032820, 366032471, 366031837, 366031504, 366030946, 366030561, 366030071, 366029625, 366029090, 366028713, 366028238, 366027747, 366027321, 366026861, 366025865, 366025246, 366024526, 366024038, 366023589, 366023138, 366022682, 366022179, 366021714, 366021250, 366020842, 366020279, 366019308, 366018970, 366018247, 366017925, 366016988, 366016619, 366015248, 366014789, 366014164, 366013846, 366013044, 366010830, 366010513, 366009717, 366009311, 366008834, 366008231, 366007661, 366007316, 366006344, 366005384, I52062487, I52062224, I52061675, I52061454, I52060803, I52060608, I52059995, I52059786, I52058636, I52058376, I52057692, I52057317, I52048664, I52048466, I52047404, I52047110, I52046647, I52046418, I52043742, I52043708,366111027 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 3750018826; 3750018468; 3750018140; 3750017888; 3750017558; 3750017267; 3750016872; 3750016618; 3750016294; 3750016103; 3750015912; 3750015355; 3750015165; 3750014628; 3750014478; 3750013901; 3750019392; 3750019209; 3750013791; 3750013274; 3750012705; 3750012296; 3750011663; 3750011357; 3750010704; 3750010364; 3750009783; 3750009359;3750008672; 3750008402 Class II Blood products, collected from a donor who was permanently deferred, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 0020185088, 0020184599, 0020184373, 0020184089, 0020183872 Class II Blood products, which were not quarantined subsequent to receiving information regarding high risk behavior, were distributed. Biomat USA, Inc.
Biologics Source Plasma 3960036260, 3960040395, 3960045419, 3960044791, 3960049126, 3960038309, 3960041518, 3960042604, 3960044381, 3960045946, 3960049362, 3960041668, 3960036528, 3960037383, 3960039345, 3960040984, 3960046561, 3960047630, 3960038635, 3960039269, 3960037127, 3960038858, 3960042900, 3960048564, 3960037839, 3960040945, 3960043000, 3960036786, 3960037820, 3960043349, 3960043948, 3960044834, 3960036398, 3960038024, 3960038438, 3960049641, 3960046652, 3960036766, 3960037199, 3960036246, 3960038727, 3960039751, 3960046557, 3960047168, 3960048574, 3960041287, 3960035846, 3960037530, 3960041029, 3960041529, 3960042520, 3960048748, 3960040882, 3960048088, 3960038704, 3960039209, 3960039132, 3960043247, 3960046343, 3960040957, 3960036795, 3960046690, 3960047822, 3960048229, 3960048016, 3960043208, 3960038207, 3960038817, 3960039478, 3960039839, 3960044368, 3960045996, 3960039230, 3960042516, 3960043563, 3960048652, 3960049172, 3960048237, 3960038729, 3960039044, 3960041088, 3960042104, 3960043206, 3960040371, 3960047916, 3960049402, 3960040124, 3960041779, 3960043161, 3960046220, 3960036695, 3960048310, 3960036017, 3960037050, 3960039042, 3960040085, 3960040718, 3960043135, 3960049163, 3960038158, 3960041166, 3960043249, 3960038300, 3960039363, 3960039358, 3960043694, 3960046521, 3960037131, 3960037657, 3960039186, 3960036240, 3960042874, 3960037096, 3960043815, 3960044337, 3960045634, 3960035655, 3960038822, 3960038549, 3960039822, 3960040428, 3960040548, 3960041023, 3960041688, 3960042726, 3960037849, 3960047692, 3960044851, 3960040355, 3960039942, 3960040810, 3960037790, 3960036830, 3960037494, 3960040527, 3960040631, 3960045772, 3960046192, 3960047675, 3960047339, 3960040297, 3960045482, 3960036191, 3960036780, 3960038795, 3960040431, 3960045591, 3960046667, 3960049120, 3960049455, 3960045541, 3960039029, 3960038867, 3960048833, 3960049470, 3960040956, 3960041983, 3960042480, 3960036045, 3960042149, 3960044233, 3960038012, 3960042637, 3960046030, 3960042652, 3960041375, 3960036848, 3960043788, 3960048104, 3960048401, 3960039737, 3960040131, 3960040738, 3960043455, 3960040497, 3960037877, 3960038276, 3960040235, 3960042244, 3960043998, 3960037067, 3960039071, 3960041330, 3960044783, 3960048955, 3960039192, 3960040484, 3960046664, 3960039630, 3960045926, 3960047655, 3960048082, 3960049595, 3960041751, 3960042316, 3960042771, 3960048807, 3960036910, 3960039341, 3960039853, 3960040854, 3960038085, 3960040676, 3960044210, 3960044843, 3960049007, 3960049339, 3960047965, 3960037172, 3960040614, 3960038116, 3960038504, 3960039464, 3960036568, 3960039075, 3960037662, 3960038044, 3960037202, 3960038776, 3960041161, 3960042321, 3960046384, 3960039759, 3960040352, 3960043534, 3960042855, 3960040452, 3960037534, 3960036301, 3960039302, 3960041776, 3960046549, 3960038714, 3960042327, 3960041548, 3960039002, 3960037848, 3960040657, 3960036179, 3960037717, 3960047360, 3960044622, 3960048305, 3960047331, 3960037241, 3960049465, 3960049791, 3960048597, 3960037370, 3960040682, 3960048222, 3960048558, 3960042222, 3960042860, 3960043277, 3960036382, 3960040003, 3960040999, 3960037149, 3960037431, 3960040055, 3960040730, 3960043774, 3960044274, 3960045914, 3960036742, 3960037144, 3960039295, 3960048466, 3960041513, 3960041840, 3960043942, 3960047520, 3960048138, 3960042885, 3960045786, 3960035973, 3960036633, 3960037018, 3960039652, 3960049604, 3960041596, 3960043597, 3960044840, 3960047359, 3960048241, 3960042177, 3960048027, 3960038110, 3960040809, 3960044150, 3960048967, 3960038741, 3960036030, 3960037057, 3960041862, 3960041532, 3960044618, 3960043126, 3960043777, 3960036814, 3960039981, 3960041961, 3960040668, 3960041704, 3960038958, 3960039988, 3960039679, 3960047802, 3960035821, 3960037509, 3960039276, 3960039684, 3960049496, 3960041851, 3960042492, 3960046095, 3960045638, 3960048300, 3960048886, 3960049359, 3960037012, 3960044400, 3960040377, 3960040913, 3960037448, 3960038442, 3960045781, 3960041870, 3960038783, 3960042832, 3960047388, 3960038813, 3960037899, 3960039051, 3960039757, 3960040099, 3960042938, 3960044634, 3960047064, 3960037434, 3960041857, 3960044571, 3960049806, 3960038580, 3960039977, 3960044075, 3960047197, 3960047890, 3960048460, 3960048884, 3960038805, 3960039457, 3960040792, 3960042513, 3960047394, 3960040481, 3960043571, 3960040285, 3960047494, 3960049376, 3960038669, 3960041173, 3960039076, 3960044652, 3960048212, 3960038638, 3960039701, 3960043853, 3960039562, 3960042188, 3960042654, 3960043846, 3960046060, 3960046539, 3960048643, 3960039880, 3960040177, 3960045757, 3960036279, 3960040232, 3960039468, 3960040059, 3960041464, 3960049041, 3960039032, 3960040655, 3960042284, 3960035840, 3960036525, 3960041885, 3960043005, 3960044063, 3960044568, 3960047814, 3960047971, 3960048265, 3960040600, 3960043399, 3960040964, 3960040538, 3960046659, 3960042645, 3960040351, 3960046530, 3960047557, 3960037006, 3960048394, 3960040135, 3960042457, 3960042881, 3960037721, 3960039313, 3960038374, 3960039233, 3960047765, 3960040684, 3960047658, 3960048270, 3960044241, 3960036548, 3960038566, 3960039556, 3960039939, 3960041586, 3960041965, 3960043016, 3960047185, 3960045394, 3960037846, 3960038816, 3960045022, 3960046055, 3960043626, 3960045478, 3960046929, 3960047626, 3960037635, 3960045574, 3960038615, 3960039151, 3960040769, 3960042236, 3960046401, 3960037189, 3960048148, 3960049392, 3960037709, 3960040047, 3960045877, 3960046920, 3960048350, 3960035984, 3960037105, 3960036792, 3960045547, 3960045938, 3960047888, 3960040822, 3960041887, 3960037783, 3960045918, 3960039455, 3960038499, 3960038881, 3960039353, 3960038659, 3960038290, 3960043447, 3960038216, 3960038914, 3960039498, 3960039906, 3960040742, 3960041762, 3960042184, 3960043123, 3960037644, 3960038187, 3960040562, 3960046936, 3960048819, 3960042170, 3960044129, 3960044360, 3960049065, 3960047568, 3960035850, 3960039654, 3960043157, 3960045569, 3960037351, 3960038701, 3960039911, 3960046082, 3960035445, 3960036062, 3960042426, 3960044872, 3960047774, 3960038429, 3960039493, 3960040075, 3960039725, 3960040071, 3960040876, 3960041893, 3960043582, 3960039099, 3960040092, 3960046701, 3960048783, 3960041013, 3960037648, 3960038261, 3960039647, 3960040224, 3960038340, 3960038046, 3960038524, 3960039027, 3960041506, 3960037528, 3960040550, 3960036983, 3960039598, 3960040194, 3960041621, 3960041579, 3960045431, 3960038963, 3960040593, 3960040976, 3960042267, 3960038593, 3960046481, 3960048363, 3960047089, 3960047544, 3960045909, 3960048260, 3960048805, 3960039289, 3960040168, 3960043798, 3960044239, 3960045227, 3960037714, 3960040479, 3960041758, 3960045040, 3960047797, 3960042196, 3960037194, 3960038182, 3960038788, 3960041213, 3960043540, 3960044324, 3960045375, 3960037081, 3960038305, 3960039877, 3960043603, 3960046216, 3960048194, 3960046052, 3960041436, 3960039887, 3960037500, 3960036483, 3960037138, 3960039272, 3960041695, 3960043164, 3960043008, 3960048462, 3960038051, 3960037088, 3960048775, 3960045511, 3960048093, 3960048746, 3960038745, 3960043806, 3960035828, 3960038630, 3960044838, 3960048209, 3960047552, 3960046550, 3960046987, 3960036097, 3960037626, 3960037989, 3960040763, 3960041181, 3960044116, 3960039224, 3960043870, 3960049675, 3960038650, 3960047515, 3960048874, 3960035709, 3960041573, 3960042174, 3960038088, 3960036854, 3960038344, 3960038930, 3960040334, 3960043945, 3960045474, 3960046032, 3960041897, 3960042939, 3960036113, 3960043758, 3960043243, 3960040430, 3960037995, 3960035436, 3960040660, 3960037703, 3960041217, 3960036425, 3960035708 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells Leukocytes Reduced W117011433853, W117011433861, W117011433878, W117011433887 Class III Blood products, collected using scales that did not meet the acceptable quality control specifications, were distributed. Blood Centers of the Pacific
Biologics Red Blood Cells Leukocytes Reduced Irradiated W117011433855 Class III Blood products, collected using scales that did not meet the acceptable quality control specifications, were distributed. Blood Centers of the Pacific
Biologics Red Blood Cells Leukocytes Reduced W128711240444 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Delta Blood Bank
Devices Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint. Catalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US. Class II Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix. Stryker Howmedica Osteonics Corp.
Devices CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation. 510K K112372 Device Listing Number D132687 US Customer IABPs CA202159K1 CA202167K1 CA203492L1 CA203494L1 International Customer IABPs CA203486L1 CA202155K1 CA202161K1 CA203487L1 CA203490L1 CA203507L1 CA204330L1 CA204328L1 CA203505L1 International Company Owned IABPs CA204327L1 CA202150K1 CA203506L1 CA204324L1 CA204326L1 CA202163K1 CA202169K! CA203497L1 CA203498L1 CA203496L1 CA203503L1 CA203488L1 CA203493L1 CA203508L1 CA204337L1 CA203502L1 Class II In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling. Maquet Cardiovascular, LLC
Devices AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse. all Class II Complaints associated with an unexpected stop in AutoPulse compressions. Zoll Circulation, Inc.
Devices Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children. 1)Philips brand FRx Model Number 861304 under 510(k) K050004, sold nationally and Internationally, Serial numbers range from BO4L-00001 through B12F-00286 and represents 181,226 devices; 2) Laerdal brand FRx Model Number 861305 unfrt 510(k) K050004, sold nationally and Internationally, serial numbers range from B04L-00013 through B12E-04135 and represents 20,372 devices. Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous. Class II Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance of all owners contacting their local Philips representative if an affected FRx or HS1 AED has emitted a pattern of triple chirps. If the device is emitting a pattern of triple chirps, it is a signal that the defibrillator's behavior needs to be investigated by Philips. Philips Medical Systems North America Co. Phillips
Devices Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children. HS1 product family all start with A in the serial number and break down into 3 catalog numbers - M5066A, M5067A and M5068A: 1) M5066A (referred to as Onsite or HS1), Philips brand, 510 (k) = K020715, sold nationally and internationally, serial numbers range from A021-00038 through A12E-03490, with 306,108 total devices. 2) M5067A, Philips brand 510(k) = K040904, sold nationally and internationally, serial numbers range from A05C-00727 through A12D-01406, with 978 total devices. 3) M5068A, Philips brand 510(k) = K020715, sold nationally and internationally, serial numbers range from A021J-00207 through A12E-01900, with 22,760 total devices 4) M5066A, Laerdal brand, 510 (k) = K020715, sold internationally, serial numbers range from A021-00036 through A12D-02148, with 60,433 total devices. 5) M5067A, Laerdal brand, sold as Home device- cleared for OTC on initial 510(k) = K040904, serial numbers range from A021-00133 through A11B-00970, with 8659 total devices. 6) M5068A, Laerdal brand, 510(k) = K020715, sold internationally, serial numbers range from A02K-00172 through A11H-00868, with 5217 total devices. Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous. Laerdal is a distribution partner in EU and Canada, sold internationally Class II Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance of all owners contacting their local Philips representative if an affected FRx or HS1 AED has emitted a pattern of triple chirps. If the device is emitting a pattern of triple chirps, it is a signal that the defibrillator's behavior needs to be investigated by Philips. Philips Medical Systems North America Co. Phillips
Biologics Bone, Human Tissue allograft; CeSpace (Brand for Aesculap, Inc.); Prepared by Aesculap, Inc., Center Valley, PA and distributed by TBI National Processing Center, San Rafael, CA CL1202013057; CL1202013061; CL1202013064; CL1202013068; CL1202013071; CL1202013075; CL1202013079; CL1202013084; CL1202013077; CL1202013083; CL1202013056; CL1202013058; CL1202013059; CL1202013060; CL1202013062; CL1202013063; CL1202013065; CL1202013066; CL1202013067; CL1202013069; CL1202013070; CL1202013072; CL1202013073; CL1202013074; CL1202013076; CL1202013078; CL1202013080; CL1202013081; CL1202013082; CL1202013085; CL1202013086; CL1202013006; CL1202013004 Class I Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed. Tissue Banks International
Biologics Tendon, Human Tissue allograft; TranZgraft (brand for TBI); Product is prepared and distributed by TBI/Tissue Banks International, San Rafael, CA CL1202013007; CL1202013008; CL1202013009; CL1202013010; CL1202013003 Class I Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed. Tissue Banks International
Devices Ultrafill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 1cc***Product Code: RT53001***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information*** TissueNet's Porcine DBM product line is used as a bone void filler Product Code: RT53001 Tissue ID: TN29041-11-0072 Through TN29041-11-0081; and TN29041-11-0083 through TN29041-11-0119 Class II Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates. Surgical Tissue Network, Inc.
Devices UltraFill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 5cc***Product Code: RT53005***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information*** TissueNet's Porcine DBM product line is used as a bone void filler. Product Code: RT53005 Tissue ID: TN48005-11-0021 through TN48055-11-0059; TN48055-11-0070 through TN48055-11-0075; TN58063-11-0101 through TN58063-11-0142; TN61039-11-0031 through TN61039-11-0097; TN70037-11-0017 through TN70037-11-0018; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056 Class II Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates. Surgical Tissue Network, Inc.
Devices UltraFill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 10cc***Product Code: RT53010***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information*** TissueNet's Porcine DBM product line is used as a bone void filler. Product Code: RT53010 Tissue ID: 07-175-330 through 07-175-359; TN61032-11-0017 through TN61032-11-0041; TN62034-11-0001 through TN62034-11-0024; TN62053-11-0155 through TN62053-11-0209; TN67049-11-0291 through TN67049-11-0316; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056 Class II Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates. Surgical Tissue Network, Inc.
Biologics Tendon 06711073061037; 06711073061038; 06711073061043; 06711073061027; 06711073061031; 06711073061041; 06711073061040; 06711073061028; 06711073061039; 06711073061029; 00311087151038; 00311087151045;0311087151039; 00311087151046; 00311087151047; 00311087151040; 00311087151042; 00311087151049 Class I .Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed. Musculoskeletal Transplant Foundation
Biologics Bone 06711073061066; 06711073061059; 06711073061067; 06711073061073; 06711073061065; 06711073061060; 06711073061061; 06711073061062; 06711073061072; 06711073061069; 06711073061070; 06711073061071; 06711073061051; 06711073061052; 06711073061053; 06711073061054; 06711073061068; 06711073061056; 06711073061057; 06711073061058; 06711073061055; 06711073061064; 06711073061063; 00311087151030; 00311087151031; 00311087151032; 00311087151033; 00311087151034 Class I Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed. Musculoskeletal Transplant Foundation
Devices Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F. Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Tray and Kit - K12T-03162B & K12T-02641F/ Lots #T243169, Exp. 2012-12, T276753, Exp. 2013-04, T282465, Exp. 2013-02, T259844, Exp. 2013-02, T265274, Exp. 2013-02, Chloride Injection Lot 05-201-JT Class II Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The particular matter may result acutely in local inflammation, phlebitis and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the body. Merit Medical Systems, Inc.
Biologics Red Blood Cells 2723207; 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 2723207; 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 Pooled Leukocytes Reduced Irradiated 2930687; 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 Cryoprecipitated AHF, Pooled W036811822350; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Fresh Frozen Plasma 2243062; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Cryoprecipitated AHF W036809216741; 2479070; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036810821967; W036809821585; W036809813222; 2911209; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036811262717; W036810243696; W036810039414; W036809359200; W036809216741; 2479070; Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells W036811262717; W036810039414; W036809359200; W036809216741; 2243062; 2479070; W036810243696; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Devices (l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel & Navigation Arm The Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1)Visum Halogen Surgical Light, (2)Visum LED Surgical Light, and (3)Stryker Flat Panel & Navigation Arm. The Spring Arm that is subject to this field action suspends loads, is a conduit for power/data, and facilitates multi-directional movement. The Spring Arms that have been identified within scope are replacement parts that have potentially been serviced incorrectly. Code Number and Product Name: 0682000112-SPRING ARM, LIGHT 12-18KG, 0682000211 - FLAT PANEL SPRING ARM, ONDAL SUSPENSION, 15-21KG, 0682000212 - FLAT PANEL SPRING ARM, ONDAL SUSP., 12-18KG, 0682000226 - SPRING ARM,3.5-7KG,NAVIGATION, 0682000228 - SPRING ARM, LIGHT 9-15KG, 0682001062 - PKG EDS LIGHT SUSPENSION CENTRAL AXIS 5P/FP, 0682001270 - 9-POLE SPRING ARM, AC 2000,15-21 KG, 0682001274 - 5-POLE SPRING ARM AC 2000 15-21 KG, 0682400034 - FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KG, 0682400059 - UNIVERSAL YOKE SPRING ARM RETROFIT KIT, 06824000591 - UNIVERSAL YOKE & SPRING ARM RETROFIT KIT, INT, 0682400151 - LOW CEILING SPRING ARM, 5P SIDE MOUNT, 0682400152 - LOW CEILING SPRING ARM, 9P SIDE MOUNT, 0682400169 - 5-POLE SPRING ARM AC 2000 9-15KG, CARDINAL, 0682400207 - STANDARD SPRING ARM WITH BEARING, 5P, 0682400208 - STANDARD SPRING ARM WITH BEARING, 9P, and 0682400365 - FLAT PANEL SPRING ARM WITH ERA ADAPTER BEARING. Class II Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. If the Spring Arm Circlip is not fully seated, the Spring Arm could separate and fall along with the surgical lights or monitors mounted to the end of the Spring Arm. To date, there have been no serious injuries reported from the incomplete engagement of the Spring Arm Circlip. Stryker Communications, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W141610180553; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Puget Sound Blood Center and Program
Biologics Red Blood Cells Leukocytes Reduced W141610178698; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Puget Sound Blood Center and Program
Biologics Red Blood Cells W141610173064; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Puget Sound Blood Center and Program
Biologics Red Blood Cells Leukocytes Reduced W036512094817 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. LifeShare Blood Centers
Biologics Cryoprecipitated AHF, Pooled W036512061595 Class III Blood product, which reached an unacceptable temperature during storage, was distributed. LifeShare Blood Centers
Biologics Red Blood Cells Leukocytes Reduced W036512045868 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. LifeShare Blood Centers
Biologics Fresh Frozen Plasma W036512045868 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. LifeShare Blood Centers
Food Kentucky Bleu cheese was sold in the Louisville, KY, Whole Foods Market store, and was cut and packaged in clear plastic wrap. It was sold with a Whole Foods Market scale label reading 'Kenny's Farmhouse Cheese KY BL. The Kenny's Farmhouse Cheese KY BL has a PLU of 209578 and includes all 'sell by' dates, which are noted on the scale label. Class I Whole Foods Market announces that it is recalling Kenny's Farmhouse Cheese KY BL sold in its Louisville, KY store and Blue Kentucky Rose Kenny's cheese sold in its Nashville, TN store. These cheeses are being recalled because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. To date, no illnesses have been reported. This recall is in response to a recall by Kenny's Farmhouse Cheese of Austin, Kentucky. Whole Foods Market Brand 365, Llc
Food The Blue Kentucky Rose cheese sold in the Nashville, TN, Whole Foods Market store was cut and packaged in clear plastic wrap. It was sold with a Whole Foods Market scale label reading 'Blue Kentucky Rose Kenny's. The Blue Kentucky Rose Kenny's had a PLU of 71113 and includes all sell by dates, which are noted on the scale label. Class I Whole Foods Market announces that it is recalling Kenny's Farmhouse Cheese KY BL sold in its Louisville, KY store and Blue Kentucky Rose Kenny's cheese sold in its Nashville, TN store. These cheeses are being recalled because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. To date, no illnesses have been reported. This recall is in response to a recall by Kenny's Farmhouse Cheese of Austin, Kentucky. Whole Foods Market Brand 365, Llc
Devices The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant. Part number: 96-701-10001; Lot numbers: " 61946711, 61946712, 61991588, 62000412, Class II Zimmer Spine, Inc. is initiating a voluntary medical device correction to the Surgical Technique (L1607) for the TM Ardis Inserter because Zimmer has received complaints reporting difficulty in turning the implant release knob after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from the patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant from the inserter. Zimmer, Inc.
Food Publix 7 Yellow Special Blend Layers, Net Wt. 14.25 lbs. (24 count), frozen in bulk paper cartons to be frosted and sold individually at the retail stores. Lot numbers: 2311B00610, 2311B00611, 23110C00611, Lot 231C00610 and 2311A00611. Class I Product sample was found to be positive for Listeria monocytogenes. Maplehurst Deli-Bake South Inc
Food Publix 7 Chocolate Split Layers, Net Wt. 12.75 lbs. (24 count), frozen in bulk paper cartons to be frosted and sold individually at the retail stores. Lot numbers: 2311B00610, 2311B00611, 23110C00611, Lot 231C00610 and 2311A00611. Class I Product sample was found to be positive for Listeria monocytogenes. Maplehurst Deli-Bake South Inc
Food Alaskan Wild Smoked Sockeye Salmon in vacuum packed plastic package, labeled in part: MICHAEL'S WILD SOCKEYE SMOKED SALMON***INGREDIENTS: WILD ALASKAN SOCKEYE SALMON, SALT, SUGAR, NATURAL HARDWOOD SMOKE.***KEEP FROZEN UNTIL USE/THAWED UNDER REFRIGERATION IMMEDIATELY BEFORE USE.***DISTRIBUTED BY: MICHAEL'S SEAFOOD INC. 500 NE 185TH STREET, MIAMI FL 33179.***READY TO EAT WITHIN 3 DAYS AFTER OPENING OR BEFORE SELL BY DATE.*** Batch #1443 Class I Michael's Gourmet Delicacies, Miami, FL is recalling their Alaskan Wild Smoked Sockeye Salmon, Batch #1443 (4oz., 8 oz., 16 oz. and Trimmings) after a sample of 4 oz. Smoked Sockeye Salmon tested positive for Listeria Monocytogenes. Michael's Seafood Inc. DBA Michael's Gourmet & Delicacies
Food Cherry tomatoes packaged in 1 pint clear, plastic clamshells. The clamshells are packaged either 9/1-pint clamshells or 12/1-pint clamshells per case. P96290001 date code: 4604 P96330002 date code: 4605 P96477001 date code: 4606 P96368001 date code: 4605 P96500001 date code: 4701 P96313001 date code: 4604 P96330007 date code: 4605 P96290006 date code: 4604 P96500006 date code: 4701 Class I The recalled cherry tomatoes are associated with the Rio Queen Citrus, Inc. recall received on November 12, 2012 and used in the packaging of certain lots of Capital Brand Clamshell Cherry tomatoes have the potential to be contaminated with Salmonella. Capital City Fruit Co.
Food TRIGAL***Empanadillas de Pizza (Pizza turnovers)***12 ct***Pastry Foods Inc., Rio Piedras, PR none Class II Undeclared milk as the source of cheese. Pastry Food Products Inc.
Food TRIGAL***Pastelillos Coctel de Pizza (Pizza Mini turnovers)***12 ct***Pastry Foods Inc., Rio Piedras, PR none Class I Undeclared milk Pastry Food Products Inc.
Devices Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes Carton/Bottle Lot Number: C9093061B P9093061B C9094081B P9094081B C0097091B P0097091B C0100101C P0100101C C0103042F P0103042F C0106062B P0106062B C91 01022D P91 01022D CP9105052B P9105052B C9108092A P9108092A Class III When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F). Siemens Healthcare Diagnostics Inc
Devices Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS® Automated urine Chemistry Analyzer and CLINITEK ATLAS® 10 reagent Pak, CLINITEK ATLAS® Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas. Carton/Bottle Lot Number: S9093061A P9093061A S9094081A P9094081A S0097091C P0097091C S9093061A P9093061A S9094081A P9094081A S0097091C P0097091C S0100101B P0100101B S0103042A P0103042A S0103042H P0103042H S0106062A P0106062A S9101022A P9101022A S9101022B P9101022B S9105052A P9105052A Class III When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F). Siemens Healthcare Diagnostics Inc
Devices Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes Carton/Bottle Lot Number: C9093061C P9093061C C9094081J P9094081J C0100101D P0100101D C0097091E P0097091E C9101022E P9101022E C0099091D P0099091D C0100101E P0100101E C9101022H P9101022H C9101022J P9101022J C0103042B P0103042B C0103042G P0103042G C0106062D P0106062D C9105052C P9105052C Class III When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F). Siemens Healthcare Diagnostics Inc
Devices Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes Carton/Bottle Lot Number: C9094081C P9094081C C0100101A P0100101A C9101022C P9101022C Class III When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F). Siemens Healthcare Diagnostics Inc
Devices Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes Carton/Bottle Lot Number: CP0099091B P0099091B C0100101G P0100101G C0103042E P0103042E Class III When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F). Siemens Healthcare Diagnostics Inc
Devices Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes Carton/BottleLot Number: C0099091A P0099091A C0100101 H P0100101 H C0103042C P0103042C Class II When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F). Siemens Healthcare Diagnostics Inc
Devices Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes Carton/Bottle Lot Number: C0099091C P0099091C C0100101F P0100101F C9101022I P9101022I C0103042D P0103042D C0106062E P0106062E Class III When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F). Siemens Healthcare Diagnostics Inc
Food Protandim is packaged in a 90cc cylindrical blue bottle with a silver cap and contains thirty caplets per bottle. Label has a blue background with multi-colored print and pictorial stating in part:Lifevantage PROTANDIM *the Nrf2 Synergizer Dietary Supplement I 30 Caplets. Lot # / Expiration Date: 12-0258 / 7/2/2015;12-0259 / 7/3/2015; 12-0292 / 7/9/2015; 12-0294 / 7/11/2015; 12-0295 / 7/12/2015; 12-0304 / 7/18/2015; 12-0306 / 8/16/2015; 12-0307 / 8/17/2015; 12-0373 / 8/21/2015; 12-0382 / 9/21/2015. Class II Possible inclusion of small metal fragments embedded within the tablets of Protandim Dietary Supplement. Lifevantage Corp
Devices ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 Lot/Serial# PML0937 Class II Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software versions are Versions 9.0.1, 9.0.2, 8.0x and below. Horiba Instruments, Inc dba Horiba Medical
Devices Laparoscope, general&plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments. Lot Number: 1179107 Class II Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107. Applied Medical Resources Corp
Devices PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Part 113950 Lot 093540, 093550,093570,093580,093590,093600,093610,093620,093720, 093730,093740,093760,093770,093780,282590,282600,282620,282630, 282680,282700,282710,489160,489180,489200,489210,489770,489780, 489790,714480,714550,714570,714700,714730,722210,722250,722280, 984770,984780,984790,984800,984810,984820,984830,984840, and 984850 Class II Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following three events: 1) If the PT Hybrid Glenoid Post is not fully seated into the Hybrid Base and the implant construct is implanted, then a gap of 1-3 mm will be present. 2) If excessive torque is applied to assemble the post into the base, the PT Hybrid Glenoid Post drive tip could break off. 3) The PT Hybrid Glenoid Post may not thread at all into the Hybrid Glenoid Base, which would prevent assembly of the two implant components. Biomet, Inc.
Devices Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status. Lots 969 and 970 Class III The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H) lot 035 calibrator vials are not affected. The darker yellow calibrator vials yield a 15-20% lower dose values compared to the target values. This may result in out of range (+2 SD) controls. Siemens Healthcare Diagnostics
Devices Immunoradiometric assay. Lots 831 and 832 Class III The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H) lot 035 calibrator vials are not affected. The darker yellow calibrator vials yield a 15-20% lower dose values compared to the target values. This may result in out of range (+2 SD) controls. Siemens Healthcare Diagnostics
Devices Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status. Lots 742 and 743 Class III The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H) lot 035 calibrator vials are not affected. The darker yellow calibrator vials yield a 15-20% lower dose values compared to the target values. This may result in out of range (+2 SD) controls. Siemens Healthcare Diagnostics
Devices STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system. Lot # 11J037, 11L038, 11J033 Class II Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life. Advanced Sterilization Products
Food Markets of Meijer 16oz Redskin Peanuts Lot 07 2234; Sell by date 12/20/2012 Lot 08 2279; Sell by date 1/1712013 Lot 07 2318; Sell by date 5/3/2013 lot 07 2340; Sell by date 5/3/2013 UPC 8-8692619797-6 Class III Sodium was not correctly stated on the label. Meijer Distribution, Inc
Devices Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma. Emit(R) 2000 Phenobarbital Assay (OSR4D229) lots 1237 and 1264 and/or Syva(R) Emit(R) Phenobarbital Assay (4D019UL), lots E1, E2, and E3. Class II Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if the AU(R) System is used, the issue may be experienced. Firm has found that within-run imprecision of the recalled lots frequency of outliers that differ from the expected value by 20%. This is an expansion of the recall initiated in July, 2012 to include additional lots. Siemens Healthcare Diagnostics, Inc.
Devices Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field. Catalog No: SU-12202 Lot No: S112462, S111480 Class II California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity. California Medical Laboratories Inc
Devices Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field. Catalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N Class II California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity. California Medical Laboratories Inc
Food Udi's gluten free au naturel granola in 12 ounce clear plastic bag, UPC 6-98997-80615-8, best by 041913 12265 1. UPC 6-98997-80615-8 Best by 041913 122565 1 Class I Product may contain undeclared almonds. Udi's Healthy Foods,Granola & Gluten Free
Food Sam's Club Artisan Fresh Miniature Candy Cookie Carton 504 Count , 28.35 lb (12.89 kg) 2 348 18 2 349 18 Class II Outer case of Sam's Artisan Fresh Miniature Candy Cookie contained White Chocolate Macadamia Nut Cookie and separate labels matching the White Chocolate Macadamia Nut Cookies. Dawn Food Products, Inc.
Devices FlowGate Balloon Guide Catheter, Manufactured by Concentric Medical, Mountain View, CA. FlowGate Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices. Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135. Class II Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration. Concentric Medical Inc
Devices Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum. Lot D1 Class III Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The correct expiration date is 2013-12-31. The incorrect assigned expiration date is 2014-12-31. Siemens Healthcare Diagnostics, Inc.
Food Yangsheng Duck Eggs Cooked Salted Duck Eggs Content:6 pieces Net Wt. 12.69 oz (360g) S & M (USA0 ENTERPRISE CORP. RED. B/T YUOXIU Bldg. 160-174 Lockhart Road, Man Chai, HK Distributed by: S & M INT'L. INC 100 Pulaski Street, Bayonne NJ 07002 UPC 6949682803568 Lot #YS12-02C Class II Cooked Salted Duck Eggs have the potential to be contaminated with C. botulinum. S & M International Inc
Food Asian Boy (EBQ) Tapioca Stick 3.5 oz (100g) New B.C.N. Trading Inc. 701 Hadky South Plainfield, NJ 07080 MINH NGUYET TRADING CO., LTD. BIN CHANH -HOCHIMINH CITY VIETNAM UPC 627404021822 UPC 627404021822 Class III Tapoica stick contains undeclared sulfites. New B.C.N. Trading Inc
Food Product labeled in part: ***PARAMOUNT RESERVE***PRODUCT OF CHILE FARM RAISED ATLANTIC SALMON PACKED BY: ALIMENTOS MULTIEXPORT S.A. *** DISTRIBUTED BY MULTIEXPORT FOODS INC. 703 WATERFORD WAY (NW 62ND AVE) SUITE 510, MIAMI, FL 33126*** Twin Pack 12 oz = 931-59733-2, 933-59753-1, 933-59754-2, 875-701413-1, and 890-701413-1 // 12oz UPC 6 88264 86705 0 ===================================== 1.25 lb Pack = 870-701342-1, 873-701342-1, 870-701344-1, 873-701360-1, 870-701364-1, 873-701364-1, 900-701344-1, 873-701344-1, 873-701360-1, 886-701413-1, 900-701413-1, 873-701344-1, and 870-701360-1 // 1.25 lb UPC 6 88264 86664 0 Class I The firm initiated the recall based on positive results for Listeria monocytogenes obtained from a composite sample tested by a private laboratory. Multiexport Foods, Inc.
Food Kinnikinnick Pie Crust Glutent Free (frozen) weight 290 g/ 10 oz Qty/Pkg: 2, UPC 620133006229, Kinnikinnick Foods 10940 120 Street, Edmonton, AB Canada. US distribution: BB2013NO30; BB2013DE12; BB2013DE13; BB2013DE14; BB2013DE17. Class I UNFI Aurora, Colorado is recalling certain Kinnikinnick Pie Crusts (frozen) because they were notified by the manufacturer, Kinnikinnick Foods (Alberta, Canada) that the products contain eggs and are not identified in the finished product labeling. United National Foods (Unfi)
-
-