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U.S. Department of Health and Human Services

Enforcement Report - Week of June 26, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides. The following serial numbers of the Aperio ScanScope systems are affected in the USA by this recall: ├┐ScanScope XT ScanScope AT ScanScope ATT ScanScope es, esa 1223, 1273, 1278, 1277, 1282, 1593,1605, 1648,1657,1660, 5064,5068,5108,5155,5170,5171 1285,1286,1287,1293,1296, 1619, 1620, 1662,1663,1666, 5176,5181,5187,5196,5198,5202, 1299,1300,1301,1302,1304, 1623, 1633, 1671, 1672, 1673, 5204,5205,5233,5236,5237,5241, 1311,1312,1314,1315,1316,  ...
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Class II Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures. Aperio Technologies Inc
Biologics Red Blood Cells Leukocytes Reduced 20E63815; 20E63822; 20E63825; 20E63828; 20E63829; 20E63835; 20E63837; 20E63843; 20E63846; 20E63857; 20E63859; 20E63872; 20E64720; 20E64725; 20E64736; 20E64739; 20KK46992; 20KK46993; 20KK46995; 20KK46999; 20KK47000; 20KK47003; 20KK47004; 20KK47006; 20KK47007; 20KK47164; 20KK47165; 20KK47171; 20KK47178; 20KK47181; 20KK47182; 20KV12550; 20KV12559; 20KV12563; 20KV12567; 20KV12575; 20KV12586; 20KV12591; 20KV12690; 20KV12692; 20KV12694; 20KV12696; 20KV12698; 20KV12700; 20KV12702; 20KV12705; 20KV12708; 20KV12709; 20KV12742; 20KV12744;  ...
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Class II Blood products, collected from donors whose arm scrub procedures were performed incorrectly, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 20KV12591; 20KV12696; 20KV12759; 20KV13110; 20KV13113; 20T92196; 20T92201; 20X33985; 20X33991; 20X33995; 20X33998; 20X34006; 20Z28093; 20Z28113; 20Z28128; 20Z28131 Class II Blood products, collected from donors whose arm scrub procedures were performed incorrectly, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 06FW99249 Class II Blood product, which tested positive for S antigen, but was labeled as S antigen negative, was distributed.distributed.. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 06KG42964, 06KG42855, 06KG42633, 06KG42531 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF 31KX00620;31KZ01164 Class II Blood products, which tested negative for HIV, but were collected from a donor who previously tested positive for HIV, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 31KX00620;31KX01047;31KX01352;31KX01728;31KZ01164;31X25240 Class II Blood products, which tested negative for HIV, but were collected from a donor who previously tested positive for HIV, were distributed. American National Red Cross (The)
Biologics Platelets 31KX01352;31X25240 Class II Blood products, which tested negative for HIV, but were collected from a donor who previously tested positive for HIV, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 31KX01728 Class II Blood products, which tested negative for HIV, but were collected from a donor who previously tested positive for HIV, were distributed. American National Red Cross (The)
Biologics Source Leukocytes 31KX01047 Class II Blood products, which tested negative for HIV, but were collected from a donor who previously tested positive for HIV, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 31KX00620;31KX01047;31KX01352;31KX02393;31KX02619;31KZ01164 Class III Blood products, which tested negative for HIV, but were collected from a donor who previously tested positive for HIV, were distributed. American National Red Cross (The)
Biologics Source Plasma LZ038995 Class III Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Interstate Blood Bank Inc Mo
Biologics Blood and Blood Products for Reprocessing 06GT60067 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 06GT60067 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 21LZ01676; 21LZ08395 Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 21LZ01676; 21LZ08395 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Cryoprecipitated AHF 21LZ01676; 21LZ08395 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Source Plasma 366077838; 366077363; 366076492; 366076083; 366074795; 366074433; 366073595; 366073096; 366071126; 366070839; 366070127; 366069292; 366068555; 366068208; 366067498; 366066997; 366066040; 366064884; 366064436, 366063804, 366063445, 366060234, 366057905, 366056671, 366057334, 366055693, 366055416, 366054835, 366054477, 366053890, 366053472, 366052557, 366052268, 366051246, 366050829, 366050326, 366049878, 366049488, 366048910, 366048223, 366048009, 366047444, 366047134, 366046093, 366045625, 366045275, 366043658, 366043127, 366042908, 366042354,  ...
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Class II Blood products, collected from a donor who was deferred due to risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells Leukocytes Reduced 55C55567, 55C55574, 55C55579, 55C55582, 55C55585, 55C55605, 55C55615, 55F27724, 55F27727, 55F27731, 55F27734, 55FR76508, 55FR76879, 55FR76883, 55FR76886, 55FR76889, 55FR76891, 55FV27304, 55FV27307, 55FV27310, 55FV27312, 55FV27314, 55FV27316, 55FV27401, 55FV27452, 55FV27454, 55FV27457, 55FV27459, 55FV27475, 55FV27477, 55FZ22426, 55FZ22429, 55FZ22431, 55FZ22433, 55FZ22434, 55FZ22437, 55FZ22626, 55FZ22636, 55R81325, 55R81338, 55R81370, 55R81373, 55R81378, 55R81380, 55R81383, 55R81385, 55R81395, 55R81488, 55R81493, 55R81496,  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Plasma Frozen within 24 hours (FP24) 55C55570, 55C55582, 55C55615, 55C55618, 55F27724, 55FR76508, 55FR76883, 55FR76891, 55FV27304, 55FV27316, 55FV27401, 55FV27477, 55FZ22433, 55FZ22434, 55FZ22437, 55FZ22626, 55FZ22641, 55R81383, 55R81385, 55R81395, 55R81398, 55R81503, 55R81507, 55R81511, 55R81522, 55S72664, 55S72671, 55S72687, 55S72718, 55S72814, 55W81355, 55FZ22634 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Whole Blood 55C55601 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Source Plasma 5090006622 5090007838 5090009528 5090009772 5090010217 5090011242 5090011570 5090012009 5090008618 5090008855 5090009091 5090009513 5090009779 5090010218 5090010474 5090010978 5090011293 5090012482 5090012720 5090013173 5090013432 5090013952 5090014202 5090014584 5090015372 5090015788 5090016130 5090016621 5090016942 5090017362 5090017732 5090018230 5090018539 5090018952 5090019410 5090020672 5090021261 5090023195 5090024312 5090024690 5090028952 5090029203 5090029522 5090029752 5090030021 5090030275 5090030869 5090031195 5090031574 5090031833  ...
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Class II Blood products, collected from donors whose physical examinations were incomplete, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 06519049; 06511074; 06503017; 06496197; 06482039; 06461867 Class II Blood products, which were not quarantined subsequent to receiving disqualifying post donation information, were distributed. Biotest Pharmaceuticals Corporation
Devices Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics. Serial Numbers: 335292 351085 351326 348891 348895 353313 358016 359426 370503 354382 354749 369640 380748 356820 362256 357699 362257 357255 358489 380361 363543 362719 363669 363544 363305 363538 365150 364211 379698 380749 375725 375727 375729 377144 381880 381881 380798/SN07000617 381877 383767/SN07000639 392883/SN08000099 394519/SN08000135 421035/SN09000031 396577/SN08000190 402575/SN08000382 397513/SN08000185 407681/SN08000345 411751/SN08000438 410786/SN08000454 417251/SN08000547 427833/SN09000208 415998/SN08000511 416000/SN08000508 421979/SN09000098 422100/SN09000216 442036/SN09000336 448226/SN09000416 455130/SN10000286 462191/SN10000266 468071/SN10000398 467831/SN10000326 471707/SN11000023 477922/SN11000076 481951/SN11000205 489697/SN11000261 Class II An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used Philips Healthcare Inc.
Devices Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics Serial Numbers: 334584 345869 349805 352617 375957/SN07000650 352645 355617 356954 363678 362217 362252 361021 364214 362429 361526 363545 363802 364816 366510 366090 367504 370290 370643 373506 372845 376998 383090 384688/SN07000603 386397/SN07000659 406161/SN08000556 386265/SN08000415 389969/SN08000090 381103/SN08000131 444254/SN09000380 406491/SN08000315 389383/SN08000100 447038/SN10000169 389970/SN08000092 406017/SN08000307 389972/SN08000080 389656/SN08000052 386679/SN08000051 390255/SN08000050 394368/SN08000196 396406/SN08000193 399529/SN08000297 401268/SN08000268 402249/SN08000323 399571/SN08000559 384510/SN07000618 402246/SN08000261 403330/SN08000296 403648/SN08000292 407890/SN08000377 405887/SN08000381 413307/SN08000521 413205/SN08000562 411311/SN08000528 419318/SN09000042 428504/SN09000200 413818/SN08000526 414461/SN08000518 414601/SN08000501 438511/SN10000166 414315/SN08000474 418205/SN08000568 419316/SN09000007 421970/SN09000058 422097/SN09000068 426137/SN09000109 430918/SN09000175 435194/SN09000234 439546/SN09000334 439739/SN09000346 436337/SN09000251 438835/SN09000295 439098/SN09000294 439817/SN09000318 443072/SN09000363 443231/SN09000368 442855/SN09000357 443453/SN09000378 456506/SN10000167 449719/SN10000034 448152/SN10000013 448150/SN10000072 449717/SN10000068 450554/SN10000096 451156/SN10000059 456283/SN10000272 456082/SN10000174 458580/SN10000196 459495/SN10000212 460074/SN10000260 460485/SN10000228 460757/SN10000290 461677/SN10000302 461229/SN10000218 462389/SN10000252 463385/SN10000344 465974/SN10000320 468064/SN10000347 466164/SN10000336 468078/SN11000032 468518/SN10000353 470291/SN10000374 471046/SN10000386 471701/SN11000054 483054/SN11000246 476276/SN11000045 480210/SN11000126 483867/SN11000298 483244/SN11000199 486144/SN11000217 488176/SN11000244 Class II An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) records shows table height measurements out of specification with the consequence of potential system mis-alignment Philips Healthcare Inc.
Devices Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications Serial Numbers: 248244 351896 304009 347726 340184 353318 316236 357275 356983 325939 325940 602603 702009 348997 362251 356153 356131 351083 356334 355648 355646 354256 355644 356526 362438 7212356 359439 357888 355621 370816 357413 367356 358322 363680 358494 7000281 363670 703465 363671 367771 375952 365956 372485 372486 369545 70700 372973 374374 375370 380750/SN0702498 385560/SN0802190 401126/SN0802540 396834/SN0802370 414494/SN0802648 429753/SN0902090 434680/SN0902161 379200/SN0802088 390276/SN0802289 390109/SN0802396 383893/SN0802238 419661/SN0902011 402570/SN0802420 425721/SN0902102 414495/SN0802649 381879/SN0802058 384511/SN0802050 384779/SN0802164 410916/SN0802636 392486/SN0802181 434675/SN1002002 427612/SN0902122 389101/SN0802194 384033/SN0802219 392505/SN0802162 392504/SN0802182 382164/SN0802018 367618 396576/SN0802233 427616/SN0902145 428232/SN0902049 415314/SN0902058 396197/SN0802210 445433/SN09000434 398178/SN0802348 427504/SN0902048 399555/SN0802572 422534/SN0902027 399153/SN0802347 422101/SN0902030 412482/SN0802683 404166/SN0802441 402844/SN0802432 402853/SN0902012 405687/SN0802469 404164/SN0802462 404459/SN0802468 407425/SN08000031 418438/SN08000110 409702/SN0802557 435537/SN0902144 408200/SN0802520 409461 414931/SN0902033 412678/SN0802695 410040/SN08000021 410038/SN08000091 410039/SN08000093 423259/SN09000074 422832/SN09000061 412921/SN0802657 427610/SN0902108 433651/SN0902114 413845/SN09000004 415626/SN08000067 416651/SN08000086 422535/SN09020032 437764/SN09000292 421977/SN09000115 455753/SN10000432 455225/SN11000051 423037/SN09000153 421032/SN09000063 421034/SN09000041 427226/SN09000209 428241/SN09000220 435420/SN09000263 441921/SN09000431 440260/SN09000350 430355/SN09000214 441778/SN09000452 440249/SN09000347 439032/SN09000305 440692/SN09000443 444627/SN10000142 442306/SN10000177 442310/SN10000149 442129/SN10000171 442235/SN10000160 455550/SN10000364 461799/SN10000347 446047/SN09000440 449718/SN10000093 446665/SN09000451 461979/SN10000701 461976/SN10000704 456093/SN10000204 453385/SN10000383 451543/SN10000100 451542/SN10000098 445533/SN10000006 456179/SN10000274 487800/SN11000531 455752/SN10000200 456282/SN10000271 459772/SN10000294 463799/SN10000400 464863/SN10000533 463407/SN10000395 464755/SN10000391 472611/SN11000056 466808/SN10000464 464981/SN10000471 471148/SN11000122 471147/SN11000120 469133/SN10000572 469559/SN10000592 473817/SN11000108 477209/SN11000148 475235/SN11000119 471047/SN10000700 471066/SN10000696 471070/SN10000695 474089/SN11000079 479766/SN11000234 487719/SN11000538 Class II Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation Acceptance Test could not be located or different templates have been used Philips Healthcare Inc.
Devices Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications Serial numbers: 316235 335517 321739 334582 359767 357879 344896 351321 356953 365640 365639 359449 363674 375601/SN0802006 368428 7272440 372848 373508 375366 396836/SN0802372 382140/SN0702475 381883/SN0802010 393931/SN0802399 396572/SN0802281 392502/SN0802179 390113/SN0802451 386784/SN0802264 381098/SN0802124 390098/SN0802242 382018/SN0802118 9000529 373499/SN0802249 383639/SN0802099 390129/SN0802521 404296/SN0802460 404298/SN0802474 416255/SN0902004 802119 409788/SN0802635 406492/SN0802489 390393/SN0802337 399024/SN0802562 402837/SN0802410 408716/SN0802551 408239/SN0802583 408240/SN0802630 408236/SN0802554 406024/SN0802481 408591 406156/SN0802537 406140/SN0802479 407675/SN0802517 408967/SN0802547 414087/SN08000100 435757/SN09000361 422092/SN0902023 415783/SN0802662 422536/SN09000199 416904/SN08000052 421962/SN09000054 429129/SN09000365 426287/SN09000096 430908/SN09000165 441638/SN09000356 456404/SN10000212 435210/SN0902204 435924/SN09000281 438069/SN09000278 439920/SN09000329 443660/SN10000010 449005/SN10000094 443235/SN09000450 448008/SN10000043 455848/SN10000351 455621/SN10000163 455622/SN10000164 449232/SN10000248 449364/SN10000078 449365/SN10000110 451680/SN10000202 457265/SN10000417 475767/SN11000387 453200/SN10000133 452170/SN10000401 453201/SN10000124 466031/SN11000053 459498/SN10000231 464880/SN10000714 464350/SN10000589 470908/SN11000183 485692/SN11000443 470803/SN10000667 475846/SN11000269 477673/SN11000278 478112/SN11000163 478232/SN11000216 480052/SN11000286 480053/SN11000288 487808/SN11000526 488714/SN11000572 492704/SN11000641 Class II Installation Acceptance Test Document (IATD) non compliant with regulations. Records shows table height measurements out of specification with the consequence of potential system mis-alignment. Philips Healthcare Inc.
Drugs Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE Lot# E112, Exp 05/14 Lot# J062, Exp 09/14 Class III Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength. Mission Pharmacal Co
Devices SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment. Lot/Serial Numbers: 91-17011 to 91-19095; 91-20889 to 91-22339 Class II A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord. Ormco/Sybronendo
Devices SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy, Made in Taiwan The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment. Lot/Serial Numbers: 3757349, 4220920, 4304917, 4367699, 436513, 4445719, 4458262, 4522605, 4581118, 4724407, 4730212 Class II A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord. Ormco/Sybronendo
Devices Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and during bed ingress and egress. Part number 00-0965-002-01 Class II The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube. Zimmer, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036812846949; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036812601445; 2032178; Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma 1650021; 9587583; 8758959; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells W036812601445; 2032178; 1650021; 9587583; 9595817; 8867631; 8758959; 8715697; 8624662; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Cryoprecipitated AHF 8624662; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets 1650021, 8867631, 8624662 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets 1614729; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells W036812426040; 1614729; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Fresh Frozen Plasma 1614729; W036812426040; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Recovered Plasma 27F08066 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. American Red Cross Greater Alleghenies Region
Biologics Red Blood Cells W088412502915; Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Blood Bank Of Hawaii
Biologics Red Blood Cells Leukocytes Reduced W045212038732; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. South Bend Medical Foundation, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W045212038732; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. South Bend Medical Foundation, Inc.
Biologics Red Blood Cells Leukocytes Reduced W115912054763; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced W036513010376; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. LifeShare Blood Centers
Biologics Source Plasma LU0573741; LU0574883; Class II Blood products, which were not quarantined subsequent to receiving information regarding post donation information, were distributed. DCI Biologicals Lubbock, LLC
Biologics Fresh Frozen Plasma 9765437; Class II Blood products, collected from a donor who was previously deferred, were distributed. Florida's Blood Centers, Inc.
Biologics Platelets Irradiated 9765437; Class II Blood products, collected from a donor who was previously deferred, were distributed. Florida's Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced 9765437; Class II Blood products, collected from a donor who was previously deferred, were distributed. Florida's Blood Centers, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W227013005263 Class II Blood products, which did not meet the acceptable product specifications, were distributed. Community Blood Center of Carolinas
Biologics Platelets Pheresis Leukocytes Reduced W227013005263; W227013005263 Class II Blood products, which did not meet the acceptable product specifications, were distributed. Community Blood Center of Carolinas
Biologics Red Blood Cells Leukocytes Reduced W0425100111425 Class II Blood product, which was incorrectly labeled as negative for the Jk(a) red cell antigen, was distributed Blood Systems, Inc
Biologics Red Blood Cells Leukocytes Reduced W037712067469 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Hoxworth Blood Center UC Medical Center
Biologics Red Blood Cells Leukocytes Reduced W037712056303; W037711104912; W037709075794; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Hoxworth Blood Center UC Medical Center
Biologics Fresh Frozen Plasma W037712089020 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Hoxworth Blood Center UC Medical Center
Biologics Platelets Pooled Leukocytes Reduced W270112233556 Class II Blood product, which was not quarantined after the donor provided information concerning a post-donation illness, was distributed. Central Pennsylvania Blood Bank
Biologics Red Blood Cells (Apheresis) W085913000399; W085913000006; W084613000079; W085913000381; W085912005583; W087112001622; Class III Blood products, which did not meet the acceptable product specifications, were distributed. Central Blood Bank
Biologics Platelets W286813054137; Class II Blood product, collected from a donor who was previously deferred, was distributed. LifeSource
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W050912104904; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated W050912007007; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Recovered Plasma W050912007007; Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells Leukocytes Reduced W050912006986; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Fresh Frozen Plasma W050912006986; Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W115113019228O; Class II Blood product, for which the quality control testing was incomplete and not documented , was distributed. LifeSouth Community Blood Centers Inc
Biologics Red Blood Cells W036812596437; 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 W036812849275; 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 Blood and Blood Products for Reprocessing W036812596437; Class III 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 Pheresis Leukocytes Reduced W039513004936; Class II Blood product, which did not meet acceptable product specifications, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Fresh Frozen Plasma W115113021564E; Class II Blood product, which did not meet required specifications, was distributed. Lifesouth Community Blood Centers - Montgomery Region
Biologics Platelets Pooled Leukocytes Reduced W037913556748; Class III Blood product, which was not quarantined subsequent to receiving post donation medical information, was distributed. LifeServe Blood Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 07FT49462 Part A; 07FT49462 Part B; 07FT49462 Part C; Class II Blood products, which were labeled as leukoreduced, but exceeded the White Blood Cell count limit, were distributed. American National Red Cross The
Biologics Blood and Blood Products for Reprocessing W118812253912; Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. The Blood Alliance, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W044413301228; Class II Blood product, which did not meet acceptable product specifications, was distributed. Northern Illinois Blood Bank dba Rock River Valley BC
Biologics Platelets Pooled Leukocytes Reduced W036813801947; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells W036812482900; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036812482900; Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma W036812440858; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells Leukocytes Reduced W036812440858; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells Leukocytes Reduced W071212042342; Class II Blood product, which was collected from a donor who had traveled to an area considered endemic for malaria, was distributed. Medic Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W043811520629 Part 1; W043811520629 Part 2; W043811521219 Part 1; W043811521219 Part 2; W043811521338 Part 1; W043811521338 Part 2; Class II Blood products, which were collected from a donor who had traveled to an area considered endemic for malaria, were distributed. LifeShare Community Blood Services
Devices Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011 Part Number 241.000.011, lot number S2004 Class II The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events. Synthes USA HQ, Inc.
Devices MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Model : Manufacturer's #M70500037 Cataogue Number: 109855 Lot numbers: 25/07 48/06 20/03 Class II A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs. Linde Gas North America Llc
Devices VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma. Lot # 1529-17-2636, expiration date 12 June 2013 Class II The firm is recalling the specific lot due to lower than expected results. Ortho-Clinical Diagnostics
Drugs HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16 Batch 608917 (exp. 02/2014), and Batch 608204 (exp. 01/2014) Class III Subpotent; 24 month stability test station Hi-Tech Pharmacal Co., Inc.
Devices GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures. The GlideScope Video Laryngoscopes system should only be used by individuals who have been trained and authorized by a physician or the institution providing patient care. The device is not life sustaining or life supporting. The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform. Model, Part and Serial Numbers: Model # GVL 3, Part # 0574-0007, Serial # range MD112388 to MD121908; Model # GVL 4 Part # 0574-0001 Serial # range LG112759 to LG122582; Model # GVL 5 Part # 0574-0030 Serial # range XL111799 to XL121759; Model # AVL 2 Part # 0574-0118 Serial # range  ...
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Class I Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature failure/breakage of the blade tip that may not be readily visible during routine inspection before or after intubation. Verathon, Inc.
Food Ginseng. American Ginseng, 4 oz. and 8 oz. retail packages and bulk ginseng in 20, 30, or 40 lbs. in a clear plastic bag. Bulk products are not labeled. No codes or lot numbers used. Production start and end date: 2/1/2013 - 3/31/2013 Class III The firm initiated this recall of "American Ginseng" because FDA lab analysis found pesticide residues. Bao Gong Da Inc
Devices Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Catalog number: 14-442021 and lot number:757910 Class II Biomet Trauma ("Biomet") has initiated a recall of Retrograde Femoral Connecting Bolt, which involves Part Number 14-442021. The connecting bolt has an undersized diameter specification that may cause an interference fit with the 4mm hex driver (Part Number: 41024) near the edge of the tolerance. If the 4mm hex driver becomes stuck in the connecting bolt it cannot be taken apart and a delay in surgery of greater than 30 minutes may occur. Biomet, Inc.
Devices Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain. Catalog number: 010001814 and lot numbers: 318520 and 644720. Class II Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone. Biomet, Inc.
Devices GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced  vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced  vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. Mfg Lot or Serial # 00000L3A331FA4 00000L3A3318C4 0S804VCUPETAWS 00S804VCUPETAW 00000LE23E908A 00000LA707B8CD 0000S704783AWS 00000L3AB67847 000D1L3AB67847 00000LA70D61FE 0000G297117701 00000LFB44C088 00000LA70D6257 00000L2E5D97AC 00000LA704C3E7 00000L021DFE17 00000L97BF02A6 00000L3AA73A5B 00000LA70AB28E 00000L3AB4D639 00000L3AB501ED 00000L3AA80D28 00000L3AB4D6CC 00000L3AB50126 SNYPHAWSERVER2 00000X12335005 00000LAEDF9764 000S704783HDCT 0D1S704783HDCT SSENTARAPETDST 00000LB8CDB088 00000LA70CF2BD 00S681342AWONC 00000L97BD2680 0S856247PETUPS 00000L3AAD0E3F 00000L3A6AB2B5 00000L3A3D0C38 00000LA7053E64 00000LA7053E11 00000H12361003 00000H12361004 0000AD13018005 00000E12291003 00000E12291004 0000AV12212003 0000AV12212004 0000AV12213001 0000AV12213002 00000R12268002 00000R12268003 00000N12226004 00000N12226005 00000L3A330899 00000L3A87FE86 00000L3A86843C 00000L3A3305A1 00000LA713783D 00000LA712A01B 00000LA7142C7C SCT428868CN4AW 00000L3AA6F64A 00000X12335002 00000Q12328002 00000Q12328001 00000H12361005 0000AP12152002 0000AP12152001 00000L02135882 00000L0257B5A9 00000L026873C9 00000L3AB68D6E 00000L12130007 00000LA7053E56 000D1LA7053E56 00000L3AADF306 00000Q13066002 00000Y13070003 00000L026F4B0A 00000R12268005 00000L3A8FD336 00000L12130001 00000L12130002 00000L02167931 00000LA707FDCA 00000LA707FDC7 00000L02687367 00000L3A373C91 00000L020E0B5F 00000LA8CE7F5A 00000L02687172 00000L3AB1FAF2 00000L021500C2 00000Y13070001 0000AE12073008 00000H12275003 00000N12226001 00000L12130003 00000L12130004 00000L12130005 00000L12130006 00000P12319006 00000P12319004 0000AG12311002 00000L12130010 00000X12335004 00000P12319007 00000X12335003 00000Q12328003 0000AE12073003 0000AV12227003 00000H12361002 00000G12164003 00000L024087F6 00000E12291002 0000AD13018004 00000U12145004 00000U12145001 0000AP12152003 0000AP12152004 00000R12268001 00000H12275001 00000J12283001 0000AE12073005 0000AD13018002 00000LA70D6AAB 00000L2E5C60F0 00000A12147003 00000A12147004 00000X12335001 00000LE23E92C2 00000L3A55F90A 00000LA70D1128 0000AS12167001 00000Q13066001 0000G408959802 00000Q13052001 0000AG12311003 00000H12361001 0000AD13018003 00000L3AB67A7B 00000L3AB68E32 00000L3A996582 00000A12147005 00000LA704ABE1 00000L3AB68D9A 0000AE12073010 0000G402803003 00000E12291005 0000AS12167005 0000AG12311001 00000L12130009 00000L3A9C89A9 00000L3A9C89B2 00000L3A9C89C9 0000AE12073004 00000P12319001 00000P12319002 00000P12319003 0000AE12073001 0000AE12073002 0000ZB11278001 00000LA704A808 00000P12319005 00000L12130008 0000AE12073006 00000Q12328004 00000Q13052002 00000Q13052003 00000Q13052004 00000Q13052005 00000LA707B89E 000D1LA707BAEE 00000LA707BAEE 00000LA709781A 0000AE12073007 0000AE12073009 00000Q12328005 00000L12044001 00000L3AB68E2F 000D1L12044001 00000E12291001 0000AG12311004 00000P12319008 00000Y13070002 00000U12145005 00000LA7043632 00000LA7047A08 00000Y12118001 00000Y12118002 00000Y12118003 00000Y12118004 0000AP12152005 00000H12275002 00000G12164001 00000A12147002 00000LA70BC75D 00000LA70C6AD8 00000L3AB2DFC1 00000L0257B67E 00000G12164002 00000L0240850F 00000L0238B080 00000L02197799 00000L3A70A966 0000AV12212001 00000R12268004 00000U12145002 00000L026876F0 00000L3AAF17E5 00000L3AADF59C 00000L3AB68F2A 00000L3AB68DBA 00000L3AB68E89 00000L3AB68DBD 00000LA8CE7D16 00000L3AB6937A 00000L3AB6928F 0000AV12227001 0000AV12213005 0000AV12212005 00000N12226002 00000N12226003 0000AV12227002 00000G12164004 0000AD13018001 00000Q13066003 00000Q13066004 0000AV12227004 0000AV12227005 000S00139ADW06 Class II GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in the PET VCAR application on Advantage Workstation or AW Server. GE Healthcare, LLC
Food Roo's Juice Tropical Orange Flavor (5% juice beverage) 10 FL OZ. (296 mL) Distributed by The Pantry, Inc. Sanford, NC 27330 Item: OR047-RTU; Lot J3119, 2013-10874 Class II The product has the potential to contain polysaccharide-based bacterial biofilm, mold, and red water mites. Jus Made, Inc
Devices IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms Model Number: S-05-100-120-G3; Lot Number 01049037 Class II There was an error on the outer labeling of this device. The inner label was correct. IDEV Technologies, Inc.
Devices BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. Lot: PHM000444, PHM000445, PHM000446, PHM000447, PHM000634, PHM000635, PHM000636, PHM000637, PHM000294 and PHM000638. Class II The product does not meet the firm's size standards, the product was produced in the incorrect size. Prism Medical Services USA
Devices BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. Lot: PHM000884, PHM000881, PHM000882, PHM000883 and PHM000885. Class II The product does not meet the firm's size standards, the product was produced in the incorrect size. Prism Medical Services USA
Devices BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. Lot: PHM000053, PHM000648, PHM000732, PHM000733 and PHM000734. Class II The product does not meet the firm's size standards, the product was produced in the incorrect size. Prism Medical Services USA
Devices BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. Lot: PHM000524. Class II The product does not meet the firm's size standards, the product was produced in the incorrect size. Prism Medical Services USA
Veterinary "***SOGevaL***KETOSEB FLUSH+PS Chlorhexidine 2%, Ketoconazole 0.2%, Phytosphingosine 0.02% Topical Antiseptic Formulation with Astringent, Cleansing and Drying Properties.***16 FL OZ***Contact Sogeval Laboratories, Inc., Oldsmar, FL, 1-800-877-0177***". All lot numbers for 16 oz bottles distributed prior to 04/17/2013. Possible affected lots: 110167 exp 08/2013 100237B exp 01/2014 120879A exp 09/2014 130052C exp 02/2015 110912B exp 10/2013 120448 exp 05/2014 120879C exp 09/2014 110912D exp 12/2013 120605B 06/2014 122000B exp 12/2014 Class III Recall due to an error on the label in which the concentration of Chlorhexidine is reported as 2%, however the actual concentration is 0.2% Sogeval Laboratories Inc
Drugs Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage diluent container, Distributed by Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017, NDC a) 0009-3124-03 and b) 0009-3447-03 Lots: a) G34908, Exp 06/14; G53479, Exp 09/14; G63442, G58347, Exp 10/14; G80133, Exp 12/14; and b) G34910, Exp 06/14; G36879, G41005, Exp 07/14; G53478, Exp 09/14; G63444, Exp 10/14; G76317, Exp 11/14. Class II Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial. Pharmacia & Upjohn LLC
Drugs Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116 Lot C88583, exp. 06/15 Class II Subpotent Drug: Product is being recalled due to an out of specification dissolution result during stability testing. Teva Pharmaceuticals USA, Inc.
Food Lightlife Farmer's Market Veggie Burgers, meat free, 12 oz/4-count bag, packaged in 5/12 oz-bag/cartons. Distributed By: Lightlife Foods, Turners Falls, MA. Case UPC Code: 20043454805252 Lot Code: 5483220300 and 5483221700 Best if Used by Dates: JULY 16 2013 and JULY 30 2013. Class I The product packaging for Lighthouse Farmer's Market Veggie Burgers may contain Lightlife Kick'n Black Bean Burgers which contain milk. The milk allergen is not declared on the Farmer's Market Veggie Burger product label. Conagra Inc
Drugs Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017. Lot #: a) C120138, Exp 07/13; b) C120137, Exp 07/13 Class III Failed Dissolution Specification Pfizer Inc
Devices Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software for the Freedom EVO 2 instrument. Instrument Freedom EVO 100 Base Unit: Material number: 10641100, Serial numbers: 1211001569, 1212000203 and 1212000205; Instrument Freedom  ...
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Class II WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock errors are ignored. If an operator presses "Continue" following a Rich User Prompt and the door has been left open, the script will progress (continue without warning). This could lead to the instrument moving unexpectedly and potentially cause an injury to the operator if they are physically inside the Freedom EVO's working area. Tecan US, Inc.
Drugs VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10. Lot #s: 11F23921A, 11G24001A, 11G24251A, 11G24471A, 11G24701A, 11G25051A, 11G25471A, 11G24341A, Exp 07/13; 11I30521A, 11I31651A, 11I31661A, 11I30481A, 11I30721A, 11I30731A, Exp 09/13; 11I32581A, 11K34241A, 11K34471A, 11K35861A, 11K36761A, 11K37451A, 11K37471A, 11K38171A, Exp 10/13; 11L40161A, 11L40201A, 11L40891A, 11L40781A, 11L40851A, 11L40921A, 11L42961A, Exp 11/13; 11M44271A, 11M44371A, 11M44381A, 11M45041A, 11M45421A, 11M45641A, Exp 12/13; 12A02161A, Exp 01/14;  ...
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Class II CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples. Sagent Pharmaceuticals Inc
Drugs Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g) Lot # 10301, Exp 05/14 Lot # 10302, Exp 05/14 Class III Failed Stability Specifications: Unable to meet shelf life expiry. Faria Limited LLC dba Sheffield Pharmaceuticals
Food MINUTE MAID ORANGE JUICE, 10oz and 15.2 oz plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA. (15.2 oz) Optimum Taste Date Code: OCT0713MDF3, OCT0713MDE3, OCT1413MDC3, OCT1413MDB3, UPC Code: 025000056031; (10 oz) Optimum Taste Date Code: SEP2313MDF3, SEP3013MDC3 and SEP3013MDE3, UPC Code: 10025000056779, GTIN Unit UPC: 00025000056772. Class II Products with the specific Lot Code and UPC Codes listed above are being retrieved because there is the potential that some of the bottles could exhibit spoilage or damage to the lip of the bottle. Coca-Cola Refreshments USA, Inc.
Food MINUTE MAID APPLE JUICE, 100% Juice, 6/10 oz and 15.2 oz, plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA. (10 oz) Optimum Taste Date Code: SEP3013MDB3, SEP3013MDD3 and SEP3013MDF3, UPC Code: 10025000056762, GTIN Unit UPC: 00025000056765; (15.2 oz) Optimum Taste Date Code: JAN0614MDC3 and JAN1314MDA3, UPC Code: 025000056017. Class II Products with the specific Lot Code and UPC Codes listed above are being retrieved because there is the potential that some of the bottles could exhibit spoilage or damage to the lip of the bottle. Coca-Cola Refreshments USA, Inc.
Food MINUTE MAID CRANBERRY APPLE RASPBERRY Flavored Juice Beverage, 15.2 oz, plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA. Optimum Taste Date Code: NOV0413MDB3, UPC Code: 025000056024. Class II Products with the specific Lot Code and UPC Codes listed above are being retrieved because there is the potential that some of the bottles could exhibit spoilage or damage to the lip of the bottle. Coca-Cola Refreshments USA, Inc.
Food MINUTE MAID STRAWBERRY PASSION Flavored Juice Beverage, 15.2 oz plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA. Optimum Taste Date Code: NOV0413MDD3 and NOV1113MDA3, UPC Code: 025000048906. Class II Products with the specific Lot Code and UPC Codes listed above are being retrieved because there is the potential that some of the bottles could exhibit spoilage or damage to the lip of the bottle. Coca-Cola Refreshments USA, Inc.
Food MINUTE MAID Mixed Berry Juice, Flavored Blend of Apple, Grape & Berry Juices, 6/10 oz plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA. Optimum Taste Date Code: SEP2313MDD3 and SEP3013MDE3, UPC Code: 10025000056793, GTIN Unit UPC: 00025000056796. Class II Products with the specific Lot Code and UPC Codes listed above are being retrieved because there is the potential that some of the bottles could exhibit spoilage or damage to the lip of the bottle. Coca-Cola Refreshments USA, Inc.
Food Gromex Camaron Entero (Whole Shrimp) Net Wt. 1 1/2 oz. 43 First St., Passaic, NJ 07055 (973) 458-9399 None Class II Whole dried shrimp may contain undeclared bi-sulfites. Anelina contains undeclared and unapproved colors.. Gromex Inc.
Food Gromex Anelina Net Wt. 1/2 oz. Gromex 43 First St., Passaic, NJ 07055 (973) 458-9399 None Class II Whole dried shrimp may contain undeclared bi-sulfites. Anelina contains undeclared and unapproved colors.. Gromex Inc.
Devices Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631) Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581. The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 lbs.) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists. 201001587 201001594 100066488 100017106 100017114 100017223 100017224 100017230 100017234 100006282 100078254 100078560 100078563 100080057 100013022 100004544 100013661 100013664 100013472 100013658 100042656 100049569 100005498 100014349 100014422 100014430 100014432 100014436 100014438 100014439 100014640 100014643 100014644 100014935 100014936 100014938 100014939 100015003 100082002 100082006 100082083 100082084 100045123 100045295 100030471 100030479 100030484 100030602 100034394 100034398  ...
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Class I Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator. Respironics California Inc
Food Box: Oskri, Sesame Bars Date Syrup, Gluten Free, Halal Vegetarian, 5 Bars each 1.9 oz (53g) total weight 9.5 oz (265g), UPC 6 66016 40052 6. Individual bar: Oskri Sesame Bar With Date Syrup,Gluten Free, Net WT 1.9 oz (53g) P3/3/13 EXP 9/9/14 Lot 84 Class II Oskri Corp. of Lake Mills, WI is recalling 1650 (5 pack) of "Sesame Bars Date Syrup" because they may contain copper shavings. Oskri Corp.
Drugs 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02 Lot #: 16-031-JT*, Exp 1APR2014; Note the * may be followed by 01 or 02 Class II Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container. Hospira Inc.
Food vega one, all-in one nutrition bar; chocolate almond flavor Added vitamins and minerals; 15 g Protein, 6 g Fiber and 1.5 g Omega Antioxidants, probiotics & greens; Gluten Free Dietary Supplement. 2.2 oz/ 63g Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC: 838766070049 Lot code 13028U, Exp 14-Feb Class I Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction. Sequel Naturals Ltd
Food vega one, all-in one nutrition bar; chocolate cherry flavor Added vitamins and minerals; 15 g Protein, 6 g Fiber and 1.5 g Omega Antioxidants, probiotics & greens; Gluten Free Dietary Supplement. 2.2 oz/ 63g Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC: 838766070056 Lot code: 13032U, 14-Mar Class I Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction. Sequel Naturals Ltd
Food vega one, all-in one nutrition bar; Double chocolate flavor Added vitamins and minerals; 15 g Protein, 6 g Fiber and 1.5 g Omega Antioxidants, probiotics & greens; Gluten Free Dietary Supplement. 2.2 oz/ 63g Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC:838766070032 Lot code: 13026U 14-Feb Class I Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction. Sequel Naturals Ltd
Food vega sport, Natural Plant-Based Protein Bar; Chocolate Coconut flavor Gluten Free; 2.1 oz/ 60g Complete protein " 4g of fiber per serving " 0.4g of Omega-3 per serving Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC:838766008301 Lot codes: 12100U 13-May 12170U 13-Jul 12238U 13-Sep 12296U 13-Nov 12346 14-Jan 13037U 14-Mar Class I Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction. Sequel Naturals Ltd
Food vega sport, Natural Plant-Based Protein Bar; Chocolate Saviseed flavor Gluten Free; 2.1 oz/ 60g Complete protein " 4g of fiber per serving " 0.4g of Omega-3 per serving Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC:838766008301 Lot codes: 12095U 13-May 12172U 13-Jul 12235U 13-Sep 12295U 13-Nov 12349 14-Jan 13038U 14-Mar Class I Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction. Sequel Naturals Ltd
Devices Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR systems produce transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The following serial numbers are associated with this recall: Echelon - V061, V062, and V065 Oasis - M009, M017, M067, M071, M084, M106-M108, M110-M141 inclusive, and M952 Echelon Oval - Y001-Y005 inclusive Class II Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. The software error can occur randomly. The error causes an image in the processed dataset to have the same unique identifier (UID) as in the scanning dataset. The processed image is stored in the place of the original image, which is lost. If the two datasets have similar anatomy, position, and orientation, the error could potentially lead to a misdiagnosis. Hitachi Medical Systems America Inc
Food ALL NATURAL Julian's RECIPE European Style Pretzel Baguette, BUTTER & SEA SALT, NET WT 11.3 OZ (320 g), UPC 8 55971 00226 9, 2 BAGUETTES, KEEP FROZEN -- Product of Germany. Manufactured for Distribution by Julian's Recipe, LLC PO Box 323, Montgomery, NY 12549. --- The product consists of a frozen pre-baked baguette filled with salted butter. The baguette was treated on the surface in a manner to obtain the characteristic appearance of a pretzel. The deep frozen and unwrapped baguette should be baked in a pre-heated oven at 180-200┬░C for about 10-12 minutes until the butter inside becomes liquid. Lot Code L2312, Best Before Date 02/10/2014 (located on the bottom right hand corner of the box) Class I Undeclared allergen, soy flour, due to repacking error. Julian's Recipe, LLC
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