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U.S. Department of Health and Human Services

Enforcement Report - Week of February 26, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 102713647 Class II Blood products, labeled leukoreduced which did not meet the requirements for leukoreduced products, were distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 102713647; 102713647 Class II Blood products, labeled leukoreduced which did not meet the requirements for leukoreduced products, were distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced GF01233 Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Blood and Blood Products for Reprocessing 104181146 Class II Blood products, collected from a donor who was taking the drug Methotrexate, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 104181146 Class II Blood products, collected from a donor who was taking the drug Methotrexate, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced GY10019 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Plasma GY10019 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Platelets Pheresis Leukocytes Reduced 107977875- part 1;107977875- part 2;107977882 Class III Blood products, which were out of controlled storage temperatures, were distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 103337718 Class II Blood product, with positive bacterial detection testing, was distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W126108008515 Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Source Plasma 0130071123, 0130070779, 0130070193, 0130069203, 0130068928, 0130066855, 0130066466, 0130066006, 0130065657, 0130064839, 0130064410, 0130063916, 0130063618, 0130063025, 0130062778, 0130062051, 0130060955, 0130060826, 0130059008, 0130058381, 0130058146, 0130055829, 0130054113, 0130052865, 0130051573, 0130051157, 0130050694, 0130050440, 0130044617, 0130044043, 0130043718, 0130043406, 0130042801, 0130039175, 0130038761, 0130038239, 0130037815, 0130037656, Class II Blood products, collected from a donor who reported receiving a body piercing within 12 months of donating, were distributed. Biomat USA, Inc.
Biologics Source Plasma 0500281651; 0500294369; 0500294890; 0500296826; 0500299056; 0500302703; 0500304763; 0500307103; 0500309060; 0500310395; 0500322858; 0500325094; 0500351111; 0500353246; 0500353922; 0500356201; 0500357166; 0500358201; 0500359246; 0500360295; 0500361342; 0500362340; 0500379313; 0500379840; 0500384493; 0500386930; 0500388405; 0500389245; 0500392470 Class II Donor Screening/Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked Biomat USA, Inc
Devices Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461. 60678937 60725698 60820102 60868357 61099266 61122455 61286984 60356456 60780951 60962055 61041381 61099267 61115876 61197682 60101457 60165562 60207649 60218165 60678939 60714704 60780952 60868358 60932395 61010681 61013650 61107937 61185828 61261813 60154179 60242174 60392816 60714705 60735829 60820103 60861042 60914270 60962060 61030191 61031913 61099268 61107952 61129838 61286986 62311946 60116999 60137567 60264359 60392817 60686417 60735830  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520. 60135114 60152390 60235174 60253671 60303868 60318915 60406045 60469637 60538425 60629952 60708626 60713650 60845570 60885012 61156076 61290771 60097888 60126180 60155283 60235175 60270647 60278995 60393280 60425089 60472771 60538426 60555772 60557775 60588046 60591903 60603145 60715075 60845571 60885014 61316528 61616158 61749182 60111959 60140238 60162141 60175614 60208384 60218727 60278996 60285802 60291544 60406046 60435612 60487168 60550156  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811. 60879678 61278171 61625237 60564708 61026414 60564708R 60564710 60915347 61141512 61142759 60639474 60782037 62046409 60155294 60206463 62120939 60206463R 60108502 60152927 60206464 60862361 60862362 60862361R 60142899 60165580 60206466 60487350 60671954 60736748 61491355 62120941 60208478 60815946 61278172 61502705 60142901 60172569 60281392 60538633 60705043 60736749 60830649 61026415 60162132 60639475 60781210 61110037 60782040 60782041 61345993  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM 61484349 62124275 62157179 61077209 61337135 61484350 60555611 60747379 60874833 61142854 61142854R 60325552 60293083 60879683 61284330 61286943 60085527 60436025 60513856 60879684 61284331 61286947 60145167 60186855 60210921 60815940 60879685 60152929 60293084 60483144 60523344 60483145 60523345 60483145R 60440756 60483146 60523346 61142856 60483147 60523347 60536820 60483148 60523350 60483149 60523353 60483150 60523355 60536821 60483151 60483152  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR Item codes starting with 0011930, 0011931 and 0011941 366026 60252546 60386429 60387234 60387236 60664570 60746113 60820564 368890 60131310 60161887 60208595 60337755 60386430 60387237 60674436 60674437 60746114 60820565 62063880 60674437R 366027 60165190 60351204 60406618 60598293 60699479 60714970 60820566 61753280 366028 368891 60189692 60510769 60699480 60714938 60820568 60189692R 366029 368892 60154515 60413139 60740818 60812406 62161712 366030 60844072 60868450 60844072R 368894  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 and X 5, VERSA-FX SHORT TUBE, 130D, 135D and 140D, VERSA-FX STANDARD TUBE, 1 and VERSA-FX SPRCNDLR TUBE, 9 Item codes starting with 001980, 001981, 0011990 and 0011991 60053473 60528659 60807849 60855076 365855 60807850 60855077 365856 60143351 60384033 60403721 60452546 60543211 60632720 60807851 368913 369123 60219007 60740783 60993433 365857 369559 371074 60539739 60807852 365859 60098398 60119108 60241936 60625494 60082810 60625506 365860 365861 60222477 60109715 60187232 366023 60161891 60116180 60175536 365749 60082811 60109716 60123966 60175537 60231394 60097992 60119110 60123967 60143352 60154511 60165702 60175538 60231395 365740 366424 60109717 60112053 60112054 60116181 60116182 60119111 60119112 60129316 60129317 60154512 60154513 60165703 60175539 60187233 60187234 60206858 60206859 60241934 60161892 365739 60109718 365738 60123968 366024 366025 60136407 365752 365751 60123969 60154514 60082812 60109719 365753 365743 60163222 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400 368278 61111052 61159202 61228030 61276758 61307948 61111052R 368279 60275442 60994837 61111053 61255583 61294523 61556944 368280 61098707 61178911 61284930 61298508 61342119 61546150 60158048 60281123 61075888 61159203 61220139 61290248 61332792 61727932 368490 60158049 60506370 60741224 60960320 61111054 61120925 61143374 61220140 61298509 61143374R 368281 60114142 60232597 60518286 60960628 60960818 61220141 61266215 61281313 61317747  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525. 60177183 60185167 60358113 60497829 60497830 60505959 60537292 60537294 60575711 60620308 60714139 60725700 60817575 60863968 60876909 61031020 61075699 61140183 61178962 61286463 61475180 61530431 60099578 60152959 60185168 60265704 60279629 60358114 60461498 60497831 60505960 60537296 60550315 60575712 60602426 60615919 60690735 60714140 60735634 60857991 60863973 60950791 60966531 61104682 61175267 61194460 61453383 61489974 60099579 60185169  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534 60179289 60196075 60208629 60272379 60279637 60367538 60438316 60575719 60597680 60620340 60714150 60735642 60864016 60937504 61031036 61040654 61120277 61133164 61186040 61325064 61446262 61551621 60129673 60177185 60187385 60363817 60387525 60569948 60602446 60620341 60630482 60711126 60714151 60735643 60808002 60819266 60864018 60864019 60876889 60876890 60956565 61104687 61112613 61133165 61266235 61422229 61458906 61489975 60690743 60711143  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530 60625043 60678699 60690742 60728338 60747676 60757045 60813551 60864020 60864021 60915935 60915936 61003973 60806395 60829584 60864023 60867711 60867767 60550320 60569951 60597681 60653347 60690746 60735651 60757047 60757048 60808005 60817585 60829586 60829587 60864037 60864038 60864040 60867771 61161394 61190864 61194691 61215177 61319429 61379510 60518291 60606752 60620346 60711145 60728343 60757050 60806397 60806398 60829592 60829594 60867782  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543. 367948 60314382 60630218 60691787 61053255 61064495 61117719 61303810 61367343 61434774 368764 369138 60219125 60391605 60468238 60645301 61040164 61040166 61092425 61271218 61298490 61332788 61415337 61565527 61711271 61748698 61565527R 368397 60136443 60269633 60393450 60894576 61031591 61079877 61191197 61242951 61294517 61490690 61578055 367232 367951 369139 60518287 60747414 61026918 61092426 61191198 61244794 61275552 61332789  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices ASIA ONE-PIECE LAG SCREW 61671102 62142296 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and 50) 60587172 60642426 60674247 60691374 60749915 60813568 60897964 60897965 60897966 60966659 60090438 60092202 60092203 60620584 60642427 60654140 60691390 60749916 60813570 60915915 60915916 60915917 60087121 60092204 60092205 60642428 60654141 60674248 60714649 60747680 60749917 60813572 60831102 60915929 60915930 60915931 60915932 60092206 60092207 60630503 60642429 60654142 60674249 60691392 60714651 60789796 60789797 60889685 60931200 61031022  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900. 60068459 60152928 60198635 60254679 60393366 60550119 60604063 60630562 60654332 60688667 60705395 60804579 61238538 60137582 60155302 60198636 60338337 60435949 60550120 60604064 60630563 60664392 60705397 61034009 60154177 60155303 60172595 60203125 60208505 60293052 60293053 60385452 60435952 60451975 60513716 60550121 60569137 60621316 60653000 60671936 60690725 60700503 60783464 60820534 60860511 60860513 60860514 60922581 60931393 61057541  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL DORSAL ULNA PLT, and PROXIMAL MEDIAL TIBIAL 4. 60123273 60132377 60140219 60141550 60142733 60148179 60155310 60165544 60186827 60195674 60200835 60216184 60220271 60220273 60226819 60252510 60252511 60259230 60262844 60264178 60281557 60291992 60311248 60336996 60351041 60366235 60379861 60389521 60445063 60463387 60517290 60517292 60530516 60564287 60581857 60581858 60581859 60581860 60674481 60674482 60714213 60714223 60714225 60714226 60857024 60857027 61019442 61516750 61616190 61635188  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6. 60484301 60536380 60565715 60753818 60817438 60864746 61003323 61059514 61081364 61121949 61135827 61387138 61783644 365466 60096346 60097010 60259990 60422473 60459752 60515365 60674982 60715057 60768520 60787821 60799626 60799627 61012710 61029791 61029797 61075345 61103552 61103553 61121950 61121951 61135828 61883369 61901575 61938344 369678 369843 60242811 60260004 60317143 60370104 60411929 60411932 60441611 60501819 60501820 60501821  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS sizes 3, 4, 5, and 6, and Mod Austin Moore Fem Stem 60204970 60242926 60877896 61059555 60148524 60162051 60187879 61178682 365451 60097214 60097216 60313377 60395244 60441594 60484309 60540466 60609930 60768532 60979646 61003342 61029820 61135862 61307977 61575440 369866 60087317 60097220 60172931 60187880 60242928 60242933 60293228 60335340 60395248 60422523 60484314 60540516 60609935 60743728 60864758 60877921 60919578 61102981 61135863 61262147 61262148 61336941 61575443 61575444 367763  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001 365614 369469 60101996 60101997 60156488 60156489 60178356 60187896 60202868 60202869 60257213 60261647 60266457 60273995 60273996 60324337 60411690 60411691 60428980 60457742 60474620 60474621 60474622 60646263 60646264 60646265 60708475 60797297 60822088 60867060 60899017 60899018 60945798 61104294 61199990 61222220 61282924 61293845 61320383 61336983 61336985 61522992 61550876 61555656 61664260 365612 369617 370353 370412 60065984 60113194 60135098 60135109 60156491 60179688 60242116 60242117 60273997 60294371 60345749 60457743 60600426 60646268 60708476 60803408 60846356 60899019 60945799 60979573 61172283 61199988 61282925 61320379 61339628 61460816 61550877 61664258 60242118 60324338 60428996 60474623 61222221 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several OD 369276 369524 60291473 60310301 60342024 60357090 60399558 60425903 60452829 60558758 60570479 60584084 60590812 60599272 60611906 60620113 60657785 60682169 60687824 60708283 60711104 60821371 60841560 60907093 60984963 61022804 61070950 61077603 61134756 61154119 61175581 61209547 61228859 61270001 61287201 61368475 61368477 61530412 61533227 61533467 61692052 61732327 61774928 61783774 61824402 61870194 61873807 61879216 61910402 61977973  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500 60114195 60595579 61077273 60187380 60610778 60796106 61137985 61249340 60105628 60595582 60919090 61277444 60330148 60732231 60945764 61283889 60219129 60579389 60756650 60965136 61207433 61242494 60244944 60579385 60756651 60965137 61233951 61593013 61887830 60105629 60166064 60224275 60244943 60337906 60461446 60586318 60595606 60696728 60808905 60906705 61018586 61103031 61180337 61249355 61341882 61422286 61526208 61636571 61717191 61770492 61887831 61929703 62048813 60213807 60331257 60579387 60941524 61233952 61687333 60099537 60139269 60194156 60244942 60330150 60436638 60614725 60681999 60838357 60945765 61089048 61207434 61378442 61585149 61770493 60105630 60191625 60200995 60610790 60858860 61180338 61770494 60139270 60209213 60310131 60579392 60713474 60906706 61089049 61378443 61902190 60503470 60678795 60897195 61233953 61770495 60124943 60230948 60420518 60676026 61056150 61445351 60177068 60330149 60504976 60671244 60897209 61146352 61770496 60294720 60503550 61018587 61585151 60233993 60501971 60834361 61160767 60105632 60503494 60586320 60595609 61238563 60125012 60504978 60844061 61265359 60266112 60503499 60860053 61207435 60209212 60382121 60491633 60671248 60847409 61070792 61238565 61497083 61911709 60099538 60395058 60503554 60682001 61228341 61266850 60160832 60367469 60503479 60858861 61207436 60310132 60491634 60671251 60991375 60105634 60139271 60213808 60330152 60461447 60652031 60861035 61180339 61422287 60135104 60194157 60266113 60334482 60436657 60503483 60667751 60834366 61146353 61445352 62143506 60125013 60213809 60330153 60503489 60965138 61504824 60177432 60263493 60503552 60858859 61331581 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST 61069810 61239668 60817848 60859538 61069808 60564425 60629462 61098322 60586662 60119138 60125003 60138865 60138866 60144492 60144493 60160818 60160819 60160820 60177055 60177056 60190191 60190192 60194090 60194091 60210614 60210615 60210616 60244036 60244045 60254555 60254559 60262556 60266099 60280552 60294695 60310003 60310009 60310017 60337897 60350850 60359183 60367447 60382117 60403684 60403685 60420502 60441357 60461431 60475823 60494867  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NEXGEN PRECOAT STEMMED TI NEXGEN OPTION STEMMED TIB NEXGEN STRAIGHT STEM EXT NEXGEN SHARP FLUTED STEM NEXGEN FLUTED STEM EXT, 1 NEXGEN FLUTED STEM EXT, 2 NEXGEN CEMENTED STEM EXT 61424993 61507222 61543969 61442278 61497511 61518148 61518149 61627190 61454951 61454952 61507223 61558358 61627192 61627198 61627202 61643930 61721669 61442310 61459958 61475125 61543975 61567342 61627206 61678232 61678233 61442319 61454955 61459970 61475130 61518182 61543977 61567344 61627260 61658886 61414605 61451226 61479488 61479489 61479490 61518197 61518198 61592093 61643938 61682157 61685470 61721675 61442326 61459971 61459972 61488229  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI 61547919 61954158 61241463 61821673 62188365 61564304 60919205 61666604 60928241 62086340 62296755 60611445 60841757 60863748 61187640 61224727 61261826 62062929 62173370 60550153 60588810 60828784 61018862 61110916 61159634 62296754 60576173 61209715 61564309 60575226 60595581 60623653 60749578 62316407 60611447 61255394 61364450 61382532 60611244 60817929 60863723 60563186 62268497 61547941 62137191 61892712 61901662 60668061 61584777 61059234 61403759 60497031 61303608 61875716 62087621 62138394 61906179 61919744 61853252 60945780 61403762 61868301 62123088 62330868 61552276 60973584 61159666 61209871 61491267 61731038 61906430 62154608 60806194 60940002 61092880 62304925 61598585 61698771 61712665 61902214 62148657 60612251 60658071 60980492 61072064 61160052 61261860 61642713 61722445 62296659 60715034 61018915 61036921 61136634 61179946 61377132 61504792 61564330 61598593 61652828 61662223 61746897 61885964 61902215 62062927 62166311 62166312 62167440 60664534 60611465 61121730 61491274 61542625 62170707 62296657 62304924 61138050 61392960 61509276 61591304 61662225 61751908 61875723 61885967 61902216 62113239 62183216 62308937 62322488 60715040 60715041 62134061 62292055 61407093 61509275 61564339 61598601 61751904 61928945 62183217 62292053 62330877 61575699 61403906 60699177 61591302 62127617 62301528 60545115 61504789 61698789 61863756 62109142 62296661 61261880 61403757 62123083 62296662 60595588 61407096 61633829 61788072 62296663 60593824 60841777 61424558 62268509 61509269 61580668 61631807 62330880 61234865 61286973 61521041 62049367 61241564 61542576 61751903 62147386 61478541 60588818 62118728 61403756 61598607 62044858 62329122 61547934 62147387 61478392 61575705 61788071 62329128 61712669 61005950 60945793 60595589 61765738 61036924 61668359 61478415 62330884 61110936 61675948 61138057 62301533 60717011 60611470 60656941 60863743 62330885 60715052 61287001 61751907 60600334 62296665 62327789 61651457 62292056 60862307 62077408 62180255 62296658 62000454 62127618 61651453 61547925 60612264 62123082 61224783 60595598 61652830 61765723 61005427 60584587 61547937 60643575 60885073 61623060 60885074 61641918 61241575 61261913 61643326 60642954 61461428 61457271 60676424 60767532 61436014 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET SHELL 42MM O TRILOGY ACET SHELL 44MM O TRILOGY ACET SHELL 46MM O TRILOGY ACET SHELL 48MM O TRILOGY ACET SHELL 50MM O TRILOGY ACET SHELL 52MM O TRILOGY ACET SHELL 54MM O TRILOGY ACET SHELL 56MM O TRILOGY ACET SHELL 58MM O TRILOGY ACET SHELL 60MM O TRILOGY ACET SHELL 62MM O TRILOGY ACET SHELL 64MM O TRILOGY ACET SHELL 66MM O TRILOGY ACET SHELL 68MM O TRILOGY ACET SHELL 70MM O TRILOGY ACET SHELL 72MM O TRILOGY ACET SHELL 74MM O TRILOGY ACET SHELL 76MM O TRILOGY ACET SHELL 78MM O TRILOGY ACET SHELL 80MM O BONE SCREW 4.5X15 SELF-TA BONE SCREW 4.5X20 SELF-TA BONE SCREW 4.5X25 SELF-TA BONE SCREW 4.5X30 SELF-TA BONE SCREW 4.5X35 SELF-TA BONE SCREW 4.5X40 SELF-TA BONE SCREW 4.5X50 SELF-TA BONE SCREW 4.5X60 SELF-TA BONE SCREW 6.5X15 SELF-TA BONE SCREW 6.5X20 SELF-TA BONE SCREW 6.5X25 SELF-TA BONE SCREW 6.5X30 SELF-TA BONE SCREW 6.5X35 SELF-TA BONE SCREW 6.5X40 SELF-TA BONE SCREW 6.5X50 SELF-TA BONE SCREW 6.5X60 SELF-TA BONE SCREW 6.5X70 SELF-TA BONE SCREW 6.5X80 SELF-TA 366971 60384272 60838522 61558081 60159292 60690384 60926262 61215883 61559843 61567731 61611793 60069675 60160804 60225912 60427290 60690394 60813602 60926263 61050686 61095381 61292658 61459870 61564135 61783434 61930401 62268587 60069675R 61157229 60042677 62243630 367119 60077122 60254935 60331076 60402575 60479496 60601302 60690396 60824152 60877128 61128097 61201897 61263144 61471012 61580824 61906180 61921675 60481374 369642 60675755  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices HGP II ACETABULAR CUP BON 60623443 61033908 60735135 60134455 61110848 60752636 60843726 61056222 60507678 60849459 60507690 60746629 60373606 60621446 60696755 60796167 60884344 60980958 61056223 61138012 61202414 61336976 61445414 61479406 61614837 61770499 61830570 62081013 62130755 62204493 60358198 60456662 60676065 60740508 60793418 60847420 60906711 60970346 61018601 61089082 61114463 61197927 61265392 61336977 61405285 61445415 61504347 61560488 61612779 61717244 61770502 61830571 61953544 62017892 62081014 62126660 62161132 62194338 62286121 60096604 60191638 60231058 60310154 60403566 60541147 60614769 60652079 60713588 60771842 60809040 60906712 60965173 61013603 61077260 61120020 61191847 61197928 61288037 61336979 61405286 61445416 61504866 61548952 61612780 61649225 61738511 61770503 61830572 61902195 61902196 62017893 62048834 62090584 62204494 62286108 60134456 60196503 60254570 60310198 60400186 60604759 60642280 60687794 60749489 60793419 60838387 60914317 60965174 61018602 61070794 61114467 61180328 61191849 61226932 61296291 61362816 61378482 61405287 61458844 61504348 61548956 61612781 61649239 61687332 61738512 61770504 61801685 61830573 61902198 61902199 62061747 62104331 62130756 62194340 62211466 62315402 60307754 60358199 60537583 60745919 60817921 60884347 60932061 61013580 61077263 61135531 61197929 61283948 61354050 61445417 61458847 61573708 61612782 61649249 61738514 61770505 61830569 61906698 61948762 62104332 62130758 62227608 62308540 60391769 60537584 60614771 60732352 60780619 60838388 60906713 60965175 61013604 61056224 61120060 61180329 61226933 61283949 61336980 61405288 61445418 61479405 61504351 61573709 61623853 61674477 61717245 61760696 61770506 61830575 61902204 62017896 62074012 62104333 62143479 62227609 62308549 60354639 60400189 60503574 60535463 60604758 60616222 60642282 60687795 60756662 60796168 60821835 60875850 60909007 60970354 61035977 61089087 61120021 61180330 61202417 61255507 61296294 61378483 61445419 61458849 61504867 61573710 61614838 61649255 61674478 61717246 61760701 61770507 61770508 61902205 61906700 62061648 62061649 62126661 62194341 62227610 62308555 60503575 60621432 60642283 60745920 60821836 60897238 60970356 61056225 61120022 61197933 61331593 61612777 61672382 61770509 62017898 62124391 62204495 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices HGP II ACETABULAR CUP MOD 60035657 60035663 60163301 60078959 60163345 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices PRESSFIT FEM ST FX 16 X 1 60621428 60667768 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices VERSYS HERITAGE FEM STEM 60888636 60953044 60953045 60990022 60990023 61037925 61101347 61190038 61199991 61216692 61231958 61337105 61337106 61337108 61337109 61380551 61393846 61395480 61395481 61395482 61457789 61488608 61501472 61528642 61607607 61613260 61631108 61636270 61640544 61658343 61727080 61795011 61803866 61830030 61841636 61841637 61859438 61860472 61878469 61880368 61903233 61936199 61980174 62001339 62024623 62055989 62055991 62097061 62106808 62143853 62147329 62147330 62199398 62199399 62213245 62232590 62240777 62257146 62268582 62268583 62281833 62298293 62305944 369871 61282966 61727082 61962092 369672 61189806 61266267 61294351 369898 61293625 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices 12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CEM LD/FX ST 18X15 VERSYS PRESS FIT LD/FX ST VERSYS PRESS FIT LD/FX SZ VERSYS ADVOCATE CEMENTED VERSYS ADVOCATE V-LIGN CE VERSYS CEMENTED FEM STEM VERSYS CT FEM STEM 11X120 VERSYS CT FEM STEM 12X125 VERSYS CT FEM STEM 13X130 VERSYS CT FEM STEM 14X135 VERSYS CT FEM STEM 15X140 VERSYS CT FEM STEM 16X145 VERSYS CT FEM STEM 17X150 VERSYS CEM/REV/CALCAR 13X VERSYS CEM/REV/CALCAR 15X VERSYS CEM/REV/CALCAR 17X VERSYS CEM/REV/CALCAR 19X 365717 366402 367390 368994 369213 369214 369215 369319 370354 370750 371011 60109630 60142945 60235507 60273068 60339025 60448362 60554135 60784634 60800920 60819863 60884374 60902584 60943291 60971162 60988528 61070891 61100359 61100360 61176577 61176578 61176579 61632276 61765960 61814863 365718 367382 368346 368981 369034 369220 369221 369268 369269 369320 370432 370439 370542 370733 60114244  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices ZIMTRON 6 DEG 22 HEADS 61841123 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices 12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M) 365365 365664 60095144 60106294 60106295 60106296 60109696 60109697 60124944 60124945 60134520 60134521 60138381 60138382 60157045 60157046 60157047 60173107 60173557 60178493 60189233 60190544 60196799 60205060 60205062 60215717 60232508 60232571 60236680 60238555 60239170 60239172 60239173 60249946 60250022 60250024 60262696 60262703 60274914 60274915 60274916 60275490 60275491 60275492 60346324 60346325 60349076 60349077 60349078 60349079  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices CPT 12/14 COCR (various sizes) 60225078 60261757 60274775 60310767 60398002 60491038 60638468 60638470 60685165 60776190 60797319 60927586 61189804 61237349 61342952 61468762 61490103 61596784 61748948 61764725 61840597 61917999 61964635 61999588 62003977 60261761 60261763 60776227 60776234 60846362 60916726 60952935 60979483 61162865 61189800 61356814 61460831 61523005 61739387 61748949 61829563 61996730 60310780 60335521 60412478 60457571 60533531 60776287 60776288 60823773 60990055 61045309 61351320 61500146 61727738 61727739 61957411 60217292 60245136 60330281 60448728 60491098 60648441 60704737 60748770 60776312 60797325 60916737 60952946 61261797 61293863 61307997 61733348 61758312 61868121 61881187 61885896 61991679 62001331 60245153 60245154 60323912 60372490 60589471 60704749 60723802 60748790 60921196 60957269 61045290 61061843 61104280 61114610 61733350 61987756 61991676 60217518 60310793 60330358 60589477 60789763 60829712 60957183 60957252 61010390 61047782 61356826 61484547 61589156 61650372 61696379 61747548 61762055 61774068 61783714 61878465 61930415 61991684 61999776 62003973 62006549 62006552 62014206 60509163 61130729 61460829 61613256 61711999 62097052 60600577 60704770 60898905 61035924 61045315 61114612 61237346 61243405 61516824 61596779 61744474 61833302 61878466 61930418 61964629 60310799 60352497 60600588 60615058 60748834 60797333 60823790 60889814 60889815 60952953 60957186 60979502 61045316 61325399 61336846 61351344 61522157 61694927 61762060 61815831 62001327 60261985 60261986 60326340 60330332 60510215 60574913 60685247 60748844 60748850 60797335 60799614 60822508 60916748 60916749 60921201 60944305 61075599 61114637 61460856 61472388 61731627 61762053 61833303 61840602 61884450 61957405 62001329 60380023 60443946 60491173 60685261 60809480 61024361 61104288 61516832 61607601 60378595 60723862 60748854 60748855 60898910 61045291 61114614 61211994 61505499 61512550 61814507 61914812 61987765 60200828 60225125 60274811 60510226 60660270 60685253 60723871 60748857 60822510 60842663 60889819 60889820 61027639 61061835 61182969 61282937 61314041 61460835 61490099 61696376 61731630 61809118 61987773 62017570 60217523 60274812 60420451 60517574 60704826 60704827 60723878 60749232 60789777 60809481 60809482 60898877 60927619 60927620 60979509 61002485 61045318 61173152 61205952 61216685 61490100 61505498 61650364 61696373 61744461 61762059 61833301 62005396 60491175 60704843 60789778 60799619 60880782 60997430 61546126 60324107 60443947 60704844 60724240 60809483 60921203 61114628 61601357 60491179 60820144 61061846 61290086 61546128 61691513 60225115 60330349 60723884 60723885 60809484 61027640 61061855 61500145 61579869 61817968 61927037 60510237 60510239 60704831 60749247 60749248 60820124 60858530 60889822 60990042 60990043 61006802 61045292 61094975 61114629 61316307 61354857 61647194 61696371 61744471 61820815 369396 60222666 60274815 60510242 60589746 60660275 60704835 60749255 60749256 60944307 60973154 60979538 61024369 61024370 61062535 61114616 61153032 61339722 61550881 61683768 61696359 61779345 61820816 369397 60225128 60704836 61024371 61066495 61490101 61790493 60704845 60777781 60803456 61770622 60789779 60979539 61664275 60704715 61035926 61075584 61325390 61520903 61636260 61762068 61878931 61993208 60809444 61061836 61297358 61473756 61522154 61589113 61790499 61993210 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices 6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE 60248716 61500239 60124919 60193878 60227863 60305825 60451065 60796836 61144521 60227864 61144525 61887185 62054654 366155 60227791 60300577 60607124 60671459 60774007 60758129 60807553 60973105 60807553R 60227802 60892289 61462907 61586239 60900891 366160 369922 60114470 60153496 60177429 60197992 60227792 60265896 60308809 60382234 60499745 60552245 60737193 60929071 61052827 61203376 61713707 61864130 61866007 60265896R 369929 370590  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices 6 DEGREE COCR FEM HEAD 36 369934 60308845 60508319 60588077 60670902 60701935 60779840 60790101 60810357 60847644 60906703 61077837 61077838 61191243 61191244 61247015 61304729 61340542 61401735 61485227 61530679 61551614 61555020 61670831 61720512 61774878 61790557 61837158 62025229 62124070 62176438 369935 60339031 60407279 60586160 60658085 60701954 60701967 60779852 60779856 60779863 60806208 60821916 60847645 60900931 61002276 61052833 61077839 61077840 61191246 61304732 61401736 61448090 61502826 61530680 61570271 61618471 61618472 61713710 61734540 61837159 61837160 61896789 62025230 62091051 62176441 62284369 60339030 60392901 60440343 60508338 60656885 60669433 60779864 60779866 60779867 60790102 60806209 60821917 60847646 61002277 61052834 61077841 61144531 61191245 61304736 61401737 61485225 61530678 61551616 61551617 61670830 61713709 61734539 61774872 61779845 61790554 61896791 61896792 62025231 62025232 62124069 62176444 62218172 60323824 60439671 60508340 60536879 60611544 60652728 60684197 60779872 60790103 60847647 60906704 61002278 61077842 61191242 61224848 61304741 61340544 61424894 61485226 61618473 61676503 61713708 61774879 61779846 61790560 61896793 62025233 62093451 62176446 62218173 60439652 60515401 60593679 60701996 60884548 60940020 61018982 61077843 61081687 61191241 61224849 61304743 61459434 61535709 61618470 61683763 61720514 61774871 61779847 61837161 61896795 62025234 62098854 62099285 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID 60169597 365445 60096116 60096117 60134409 60845244 61059560 61613250 366221 60096118 60553617 60743729 60990038 61298521 365622 60096119 60411949 60501830 60540531 60609946 60700469 61657255 365458 60110443 60154855 60187556 60301871 60484369 60590160 60716272 60768572 60887301 61118584 61211680 61304669 61589078 61619986 366386 60096121 60124827 60169413 60242838 60301886 60411970 60484390 60540735 60565849 60610009 61122126 61401537 61694181 61878452 61934378 61992515 365461 366387 367572 60109037 60110290 60124913 60169470 60204787 60242845 60326542 60395275 60423101 60474918 60484409 60768593 60845456 61199171 61298517 61613251 61817985 61992516 365499 367548 369841 60096125 60110448 60148883 60242895 60293315 60484704 60540826 60581312 60737211 61103540 61324218 61619209 61659604 61758278 61817987 366388 369882 60109039 60124924 60134410 60169479 60187599 60242901 60293321 60335415 60442118 60506747 60993378 60993379 61118585 61276626 61398796 61651794 61756168 61758280 60096126 60187653 60412010 60537009 60574597 60787916 61118586 61932403 366389 369842 60124934 60187682 60274760 60423134 60980807 61231910 61651793 61837093 365464 365604 60096127 60355236 60540889 60565935 61662668 61976171 365444 60085816 60148884 60484813 61042186 61290074 61528630 61744433 60301911 60541000 61059561 61555631 61658313 366382 60154916 60395295 60900095 61324217 60096128 60541001 61370524 365448 60096186 60553915 61496597 60096187 60096188 366307 60096189 60096190 60166763 367542 60110458 60301876 60906529 60169412 60326978 60484392 61895487 60099418 60242846 60506729 60096192 60096193 365496 60523403 60331362 365481 366300 61222214 365500 60906530 61886563 366301 60096195 60484817 61886564 365449 366304 60423158 60906531 60096202 60331367 365616 366578 367657 369317 60101998 60101999 60113196 60113197 60145797 60156493 60178358 60187897 60213589 60274027 60284125 60284126 60294382 60313728 60382721 60411695 60467652 60474624 60614956 60708479 60793758 60822078 60822089 60876798 60899020 61092517 61104296 61172285 61199985 61243392 61282926 61293847 61336987 61435528 61555658 61664257 61696348 369400 60102000 60102001 60113198 60135105 60135108 60156495 60156496 60178359 60187902 60213591 60222247 60234255 60273998 60275695 60294383 60313730 60313732 60324334 60345750 60382722 60411698 60457745 60474626 60535059 60551516 60589262 60708480 60793770 60822079 60822090 60876799 60899021 61092518 61172276 61172277 61199987 61263822 61282922 61293846 61337003 61435527 61460812 61522994 61550878 61555659 61696349 365615 365617 369401 60145802 60187905 60324336 60429016 60474628 60474629 60803409 61115345 61351331 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes) 60275282 60089260 60145841 60147718 60156456 60089259 60156459 60200116 62135079 62079190 60732916 60638837 62094973 61887194 60457227 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices FEM HD ION (various sizes) 61401713 60282649 60291491 60362702 60586125 60977398 61089134 62051714 60530561 60759915 60939995 61275826 60169621 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S 60117014 60126278 60155287 60178897 60208414 60240381 60265317 60469641 60667003 60757014 60818325 60868434 60877876 60953936 61057493 61083223 61144260 61382948 61428496 61434453 60123231 60145083 60172484 60210898 60235186 60240382 60318917 60367391 60451947 60491785 60589767 60665682 60665683 60757015 60810891 60926378 60930484 60953937 60953938 61045584 61109124 61135014 61144262 61428498 61437196 60096548 60109535 60111962 60126279 60132072  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN) 60102586 60132471 60142537 60145090 60208438 60210902 60218747 60265332 60316667 60380272 60387522 60425078 60451935 60491775 60504962 60538423 60569271 60629869 60629870 60671868 60690620 60735901 60790633 60828403 60859841 60885052 60910023 60926381 60938165 60997341 61008512 61045578 61049489 61063879 61085581 61087377 61120002 61160484 61160485 61179531 61276833 61441956 61457387 61513903 61626104 61660625 61664773 61677697 61677702 61705589  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM STE PERI SCR. 3.5MM X 65MM PERI. SCR 4.0MM X24MM PERI. SCR 4.0MM X40MM PERI SCR. 4.0MMX14MM FULL PERI SCR. 4.0MMX32MM FULL PERI SCR. 4.0MMX38MM FULL 3.5MM CORT SCR X 10MM 3.5MM CORT SCR X 12MM 3.5MM CORT SCR X 14MM 3.5MM CORT SCR X 16MM 3.5MM CORT SCR X 18MM 3.5MM CORT SCR X 20MM 3.5MM CORT SCR X 22MM 3.5MM CORT SCR X 24MM 3.5MM CORT SCR X 26MM 3.5MM CORT SCR X 28MM 3.5MM CORT SCR X 30MM 3.5MM CORT SCR X 32MM 3.5MM CORT SCR X 34MM 3.5MM CORT SCR X 36MM 3.5MM CORT SCR X 38MM 3.5MM CORT SCR X 40MM 3.5MM CORT SCR X 42MM 3.5MM CORT SCR X 44MM 3.5MM CORT SCR X 46MM 3.5MM CORT SCR X 48MM 3.5MM CORT SCR X 50MM 3.5MM CORT SCR X 52MM 3.5MM CORT SCR X 54MM 3.5MM CORT SCR X 56MM 3.5MM CORT SCR X 58MM 3.5MM CORT SCR X 60MM 3.5MM CORT SCR X 65MM 3.5MM CORT SCR X 70MM 3.5MM CORT SCR X 75MM 3.5MM CORT SCR X 80MM 3.5MM CORT SCR X 85MM 3.5MM CORT SCR X 90MM 3.5MM CORT SCR X 100MM 3.5MM CORT SCR X 105MM 3.5MM CORT SCR X 110MM CANC SCR 4.0MM X 10MM CANC SCR 4.0MM X 10MM FUL CANC SCR 4.0MM X 12MM CANC SCR 4.0MM X 12MM FUL CANC SCR 4.0MM X 14MM CANC SCR 4.0MM X 14MM FUL CANC SCR 4.0MM X 16MM CANC SCR 4.0MM X 16MM FUL CANC SCR 4.0MM X 18MM CANC SCR 4.0MM X 18MM FUL CANC SCR 4.0MM X 20MM CANC SCR 4.0MM X 20MM FUL CANC SCR 4.0MM X 22MM CANC SCR 4.0MM X 22MM FUL CANC SCR 4.0MM X 24MM CANC SCR 4.0MM X 24MM FUL CANC SCR 4.0MM X 26MM CANC SCR 4.0MM X 26MM FUL CANC SCR 4.0MM X 28MM CANC SCR 4.0MM X 28MM FUL CANC SCR 4.0MM X 30MM CANC SCR 4.0MM X 30MM FUL CANC SCR 4.0MM X 32MM CANC SCR 4.0MM X 32MM FUL CANC SCR 4.0MM X 34MM CANC SCR 4.0MM X 34MM FUL CANC SCR 4.0MM X 36MM CANC SCR 4.0MM X 36MM FUL CANC SCR 4.0MM X 38MM CANC SCR 4.0MM X 38MM FUL CANC SCR 4.0MM X 40MM CANC SCR 4.0MM X 40MM FUL 61337161 61251498 61251499 61220432 61553288 61966252 61966257 60856802 60871924 60871946 60837236 61168818 61168821 61251340 61168823 61251341 61168825 61216588 61247526 61168827 61216589 61247527 61168829 61216590 61247528 61168830 61216591 61247529 61168831 61247530 61168833 61216593 61247531 61168835 61247532 61168837 61216596 61247533 61168839 61168841 61168842 61168843 61168845 61247536 61168847 61223705 61168849 61168850 61168852 61168854 61168856 61168858 61168859 61168860 61168861 61168862 61567437 61411579 61678383 61678382 61835910 61835909 61214649 61216599 61214650 61216602 61251346 61216605 61591005 61190532 61190535 61740546 61190538 61190539 61401997 61190540 61190543 61560426 61823977 61190544 61190546 61740547 61190547 61190549 61740548 61190551 61190552 61560430 61190554 61190555 61560431 61190618 61190619 61740550 61190620 61190627 61560427 61190628 61190629 61401998 61190630 61190632 61740551 61190633 61190634 61740552 61190635 61190636 61740553 61190638 61190639 61190640 61190641 61190642 61740554 61190643 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices 2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2.7 X 12 CORT SCREW/SELFT 2.7 X 14 CORT SCREW/SELFT 2.7 X 16 CORT SCREW/SELFT 2.7 X 18 CORT SCREW/SELFT 2.7 X 20 CORT SCREW/SELFT 2.7 X 22 CORT SCREW/SELFT 2.7 X 24 CORT SCREW/SELFT 2.7 X 26 CORT SCREW/SELFT 2.7 X 28 CORT SCREW/SELFT 2.7 X 30 CORT SCREW/SELFT 2.7 X 32 CORT SCREW/SELFT 2.7 X 34 CORT SCREW/SELFT 2.7 X 36 CORT SCREW/SELFT 2.7 X 38 CORT SCREW/SELFT 2.7 X 40 CORT SCREW/SELFT 2.7 X 42 CORT SCREW/SELFT 2.7 X 44 CORT SCREW/SELFT 2.7 X 45 CORT SCREW/SELFT 2.7 X 46 CORT SCREW/SELFT 2.7 X 48 CORT SCREW/SELFT 2.7 X 50 CORT SCREW/SELFT 4.0 X 20 CANC SCREW/SELFT 61173335 61173337 61173339 61173340 61173341 61115956 61173344 61173346 61173347 61173349 61173350 61173352 61173353 61173354 61173355 61173356 61173357 61173358 61173359 61173360 61173361 61173362 61173363 61173364 61173365 61173366 61359816 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices X 65 PART THD CANC SC 4.0 X 70 CANCELL. SCREW 4.0 X 70 PART THD CANC SC 4.0 X 75 CANCELL. SCREW 4.0 X 80 CANCELL. SCREW 4.5 X 16 CORT SCREW SELF 4.5 X 22 CORT SCREW SELF 4.5 X 24 CORT SCREW SELF 4.5 X 26 CORT SCREW SELF 4.5 X 28 CORT SCREW SELF 4.5 X 30 CORT SCREW SELF 4.5X30 MALLEOLAR SCREW 4.5 X 32 CORT SCREW SELF 4.5 X 34 CORT SCREW SELF 4.5 X 36 CORT SCREW SELF 4.5 X 38 CORT SCREW SELF 4.5 X 40 CORT SCREW SELF 4.5X40 MALLEOLAR SCREW 4.5 X 42 CORT SCREW SELF 4.5 X 44 CORT SCREW SELF 4.5 X 46 CORT SCREW SELF 4.5 X 48 CORT SCREW SELF 4.5 X 50 CORT SCREW SELF 4.5 X 52 CORT SCREW SELF 4.5 X 54 CORT SCREW SELF 4.5 X 56 CORT SCREW SELF 4.5 X 58 CORT SCREW SELF 4.5 X 60 CORT SCREW SELF 4.5 X 62 CORT SCREW SELF 4.5 X 64 CORT SCREW SELF 4.5 X 70 CORT SCREW SELF 6.5 X 50 CANC SCREW, 32MM 6.5 X 55 CANC SCREW, FULL 6.5 X 60 CANC SCREW, FULL 61267037 61195515 61233513 61255911 61196113 61255912 61255913 61196115 61233517 61255914 61255915 61255916 61196121 61196122 61759822 61196123 61582530 61605810 61196124 61582531 61196125 61196126 61582532 61196127 61759823 61196128 61196129 61196131 61196132 61196133 61196134 61196460 61196461 61168863 61234474 61196462 61196463 61234476 61247538 61196464 61225322 61234477 61196465 61234479 61168867 61196466 61234480 61196467 61234481 61196468  ...
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Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices 3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE 3.5 COMP PLT, 8 HOLE 3.5 COMP PLT, 9 HOLE 3.5 COMP PLT, 10 HOLE 61270590 61270591 61450581 61270594 61270595 61270596 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Devices 3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3.5 X 20 CORT SCREW SELFT 3.5 X 22 CORT SCREW SELFT 3.5 X 24 CORT SCREW SELFT 3.5 X 26 CORT SCREW SELFT 3.5 X 28 CORT SCREW SELFT 3.5 X 30 CORT SCREW SELFT 3.5 X 32 CORT SCREW SELFT 3.5 X 34 CORT SCREW SELFT 3.5 X 36 CORT SCREW SELFT 3.5 X 38 CORT SCREW SELFT 3.5 X 40 CORT SCREW SELFT 3.5 X 45 CORT SCREW SELFT 3.5 X 50 CORT SCREW SELFT 3.5 X 55 CORT SCREW SELFT 3.5 X 60 CORT SCREW SELFT 3.5 X 75 CORT SCREW SELFT 61173204 61173205 61173206 61804309 61173207 61804310 61173208 61117130 61173210 61173212 61173213 61173214 61173215 61173216 61173218 61173219 61173220 61173221 61173223 61173224 61173226 61173228 61173231 Class II Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations. Zimmer, Inc.
Food Digestive enzyme capsules sold under the NOW Foods, Beeyoutiful, Best in Nature, Bluegrass Naturals Vitamin Company, Chicago Nutrition Company, Gluten-Free Remedies, Osa's Garden, and Professional Naturopathics brands and packaged in a plastic bottle containing 60 or 120 capsules. *** 1) Product Code 2965; Lot Numbers: 1660276, 1653504, 1634330, 1618025, 1606053, 1587905, 1539085, 1518136, 1497964, 1476818. *** 2) Product Code 2968; Lot Numbers: 1645219, 1630289, 1616607, 1607295, 1593903, 1549088, 1536759, 1528258, 1516482, 1511273, 1483789, 1470001, 1458643. *** 3) Product Code 102965; Lot Numbers: 1649254, 1643889, 1632228, 1630192, 1622153, 1618074,  ...
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Class II Digestive enzyme capsules manufactured by NOW Foods may contain the antibiotic chloramphenicol. NOW Foods
Devices Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit 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. Custom procedural trays 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/Kit SPPT-5F-10/D, Lot # T491273 , Exp. 31-Dec-2014, SPPT-5F-10/D, Lot # T512967,  ...
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Class I Custom Procedural Trays/Kits which contain 1% Lidocaine HCl injectio were recalled because one confirmed customer report where visible particulate were found in the primary product container in the form of dark red/black particles. The particular matter may dislodge through the tissue and could possibly cause a pneumothorax or hemothorax. Merit Medical Systems, Inc.
Devices Access 2 Immunoassay System Analyzer. K922823/A007. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Part Number 81600N. Serial Numbers 508957, 508963, 508964. Class II Beckman Coulter initiated a recall of the Access 2 Beckman Coulter initiated a recall of the Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access becausethey may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results. Beckman Coulter Inc.
Devices UniCel DxI 600 Access Immunoassay System Analyzer. K023764. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Part Number A30260. Serial Numbers 900781. Class II Beckman Coulter initiated a recall of the Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access becausethey may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results. Beckman Coulter Inc.
Devices Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat. Serial No: 1306, 1313, 1342, 1349, 1362, 1358, 1359, 1392, 1391, 1406, 1402, 1407, 1426, 1441, 1451, 1018, 1453, 1399, 1523, 1477, 1480, 1482, 1497, 1494, 1505, 1516, 1533, 1537, 1536, 1535, 1542, 1544, 1549, 1543, 1550, 1562, 1563, 1566, 1580, 1572, 1573, 1574, 1571, 1578, 1583, 1641, 1593, 1591,  ...
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Class II Power Superstand Standing Wheel chair, flex shaft (the flexible wand which supports the joystick control module) may fracture if it is bent repeatedly and /or beyond 90 degrees. A newly designed Flexshaft which corrects this problem is available at no charge. The Standing Company
Devices External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental Lot Number 1302762, Exp 31 MAY 2018 Class II The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length. BioHorizons Implant Systems Inc
Biologics Source Plasma TT0293525; TT0293738; TT0294774; TT0295033; TT0299609; TT0299911; TT0301422; TT0302615; TT0302930; Class II Blood products, collected from a donor whose physical examination was incomplete, were distributed. DCI Biologicals Temple Terrace, LLC
Biologics Source Plasma SA0015984; SA0016100; SA0016594; SA0016704; SA0016904; SA0017498; SA0017779; SA0018020; SA0023090; SA0023184; SA0023436; SA0023525; SA0023793; SA0023967; SA0024162; SA0024359; SA0024732; SA0024955; SA0025171; SA0025426; SA0025652; SA0027251; SA0027604; SA0027737; SA0027966; SA0028102; SA0028315; SA0028472; SA0028877; SA0028966; SA0029196; SA0029323; SA0029557; SA0029711; SA0029948; SA0030102; SA0014673; SA0015398; SA0015482; Class II Blood products, collected from a donor who engaged in high risk behavior, were distributed. Dci Biologicals Llc
Biologics Platelets Pooled Leukocytes Reduced W036811805704; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing W036811074718; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, was distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036213722644; Class III Blood product, with insufficient red cell preservative solution added, was distributed. Belle Bonfils Memorial Blood Center
Biologics Blood and Blood Products for Reprocessing W204113003575; Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced W117013545858; Class II Blood product, which was not prepared according to specifications, was distributed. Blood Centers of the Pacific - Irwin Center
Biologics Plasma Frozen within 24 hours (FP24) W0410130933715; W041013033805T; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Blood Systems Inc
Devices Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump. 400064, 400069, 400070, & 400072 UPC: 7613117009502 Class II Perrigo was notified by our supplier, Ypsomed AG, that they are recalling these batches due to being manufactured with a non-conforming female luer-lock connector. The luer-lock connectors are incompatible with standard male luer-lock connectors for use in connection to compatible infusion pumps. Perrigo became was notified of a quality complaint related to this issue on November 20, 2013 from a distribution customer. Perrigo Diabetes Care
Devices Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. 4 lots: 4505268906, 4505336973, 4505408485, 4505238953 Class II The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L. Aesculap, Inc.
Food BACA'S GC Hot 12-13oz Z, Product Item Number 1010-0. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. Lot 2463 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Autumn Roast Exclusive Hot 5-5# Z, Product Item Number 1015-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2393, 2433, 2443, 2453, 2503, 2523, 2533, 2713, 2723, 2733 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hatch Valley XXXHot 5-5# Z, Product Item Number 1020-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2283, 2333, 2343, 2413, 2813 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM XHot 12-13 oz Z, Product Item Number 1021-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. Lots 2333, 2763, 2813 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hot 12-13 oz Z, Product Item Number 1022-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. Lots 2163, 2243, 2253, 2423, 2473, 2583, 2593, 2743, 2753, 2813 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC Organic Mild 12-13 oz Z, Product item Number 1023-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. Lot 2233 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Mild 12-13 oz Z, Product Item Number 1024-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. Lots 2183, 2193, 2413, 2483, 2493, 2593, 2803, 2813 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. Lots 2383, 2393, 2433, 2443, 2453, 2523, 2543, 2733, 2773, 2783 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hatch Valley Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. Lots 2113, 2523, 2533, 2543, 2773, 2783, 2843 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hatch Valley Blakes SuperHot 5-5# Z, Product Item Number 1028-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2743, 2753, 2763, 2863 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hot 28oz, Product Item Number 1032-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 28 oz each per case totaling 10.5 lbs. Lots 2143, 2173, 2613, 2633, 2683, 2693, 2703 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Mild 28oz Z, Product Item Number 1034-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 28 oz each per case totaling 10.5 lbs. Lots 2143, 2173, 2323, 2603, 2623, 2683, 2693 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hot 6-56oz Z, Product Item Number 1042-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs. Lots 2263, 2353, 2403, 2833, 2863, 2873 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Mild 6-56oz Z, Product Item Number 1044-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs. Lots 2413, 2643, 2663, 2673, 2883 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Exclusive XHot 6-56oz Z, Product Item Number 1048-5. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs. Lots 2653, 2663 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food GC Medium 5-5# Z, Product Item Number 1055-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lot 2813 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food GC NO LABEL Hot 5-5# Z, Product Item Number 1056-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lot  2673 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food GC Exclusive Hot 5-5# Z, Product Item Number 1056-2. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lot 2763 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hot 5-5# Z, Product Item Number 1056-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2343, 2353, 2413, 2423, 2483, 2633, 2663, 2673, 2703, 2713, 2723, 2743, 2753, 2763, 2803, 2813, 2823, 2833, 2853, 2863, 2893 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Reserve Hot 5-5# Z, Product Item Number 1056-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2613, 2633 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hatch Valley Hot 5-5# Z, Product Item Number 1056-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2143, 2243, 2253, 2263, 2413, 2423, 2633 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hot 5-5# Z, Product Item Number 1056-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2143, 2163, 2213, 2243, 2253, 2263, 2333, 2343, 2403, 2413, 2703 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC Exclusive Shot 5-5# Z, Product Item Number 1056-8. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2413, 2833 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food GC NO LABEL Mild 5-5# Z, Product Item Number 1057-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2683, 2873 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Mild 5-5# Z, Product Item Number 1057-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2173, 2203, 2363, 2393, 2463, 2483, 2493, 2503, 2593, 2603, 2623, 2643, 2653, 2663, 2883 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Reserve Mild 5-5# Z, Product Item Number 1057-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2603, 2623 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hatch Valley Mild 5-5# Z, Product Item Number 1057-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots  2173, 2183, 2203, 2223, 2273, 2283, 2303, 2593, 2603, 2623 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Mild 5-5# Z, Product Item Number 1057-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2203, 2223, 2363, 2503, 2583, 2683, 2173, 2203, 2213, 2223,2273, 2433, 2463, 2483, 2493, 2503, 2513, 2623, 2653, 2673,2763 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food GC Autumn Roast NO LABEL Hot 5-5# Z, Product Item Number 1062-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2773, 2783, 2843 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2133, 2293, 2373, 2453, 2533, 2543, 2573, 2733, 2773, 2783,2793, 2803, 2843, 2853, 2260, 2383, 2402 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2213, 2283 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC Strip Mild 2-12.5# Z, Product Item Number 1071-4. Packaged in double-poly bags. Lots 2333, 2483, 2493, 2613 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC Strip Hot 2-12.5# Z, Product Item Number 1072-4. Packaged in double-poly bags. Lots 2273, 2283, 2343, 2603, 2633, 2703, 2743, 2883 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC Whole Mild 2-12.5# Z, Product Item Number 1073-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs. Lots 2193, 2323, 2693, 2803 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hatch Valley Mild 2-12.5# Z, Product Item Number 1077-6. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs. Lots 2193, 2323, 2693, 2803 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Hot 2-12.5# Z, Product Item Number 1081-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs. Lots 2573, 2583, 2593, 2693 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC Autumn Roast Strip Medium 2-12.5# Z, Product Item Number 1090-5. Packaged in double-poly bags and not sealed. Lots 2373, 2383, 2393, 2433, 2503, 2543, 2773, 2783, 2793, 2843,2853 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC NM Mild 2-12.5# Z, Product Item Number 1093-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs. Lot 2203 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Food Bueno GC 1.5 Hot 5-5# Z, Product Item Number 1096-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs. Lots 2323, 2613 Class II Products were recalled due to possible Listeria monocytogenes contamination. El Encanto, Incorporated
Devices Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Model 4.2.1 Class II Potential collision risk when using XVI and external beam shaping devices. Elekta, Inc.
Devices Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept the registration and the Table Move Assistant dialog box appears. (3) The Relative Actual column of the Table Move Assistant dialog box incorrectly appears blank. (4) When this occurs, XVI does not read the Absolute Actual position of the treatment table. This causes XVI to calculate the treatment table moves from the zero position of the treatment table (+0.0, + 0.0, + 0.0). (5) In XVI R5.0, if the Relative Set values are less than or equal to + or -2.5cm (for earlier releases of XVI, the value is + or -2cm), you can do remote automatic table movement (RATM) from the function keypad (FKP). (6) When you press the Table ASU (automatic setup) buttons, the treatment table moves to a position that was incorrectly calculated from XVI. Model 4.5, 4.5.1, 4.6, 5.0 Class II XVI can incorrectly calculate the target position of the treatment table. Elekta, Inc.
Food Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO HUMAN MILK - DO NOT ADD WATER NET WT 0.031 OZ (0.90g)***CONTAINS MILK AND SOY INGREDIENTS***USE BY***ABBOTT LABORATORIES" Lot # L31056Z200, List # 54598-934(13) & USE BY 2015FE1; Lot L27385Z200 List # 54598-934(13) USE BY 2014OC1 & Lot L30698Z200 List # 54598 -934(13) USE BY 2015JA1 Class II Abbott Nutrition (AN) recalled this product from the Canadian market because some of the packets may have an incomplete seal which could allow air to enter the packet causing food oxidation and/or the powder to leak Abbott Nutrition
Devices SAFSITE® Injection Sites and IV Sets manufactured with SAFSITE® Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Catalog #351559: batch #s 0061339694, exp. 9/30/2018, 0061338909,exp. 9/30/2018, 0061333582, exp. 8/31/2018; catalog # 352016, batch # 0061326956, exp. 10/31/2018; catalog # 352079, batch #0061333591, exp. 8/31/2018; catalog #352448, batch # 0061334116, exp.9/30/2018; catalog #473017, batch #0061332459, exp. 8/31/2018; catalog # 473017, batch #061335025, exp. 9/30/2018; catalog #473309, batch #s  ...
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Class II Complaints were received reporting leakage on certain lots of SAFSITE® Injection Sites and IV Sets manufactured with SAFSITE® Injection Sites.The SAFSITE® Injection Site is intended to provide needle free access on IV and Extension Sets. B. Braun Medical, Inc.
Devices Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients. Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938 Class II Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the Siemens Prisma 2K hearing aid under certain unintended use conditions. Siemens Hearing Instruments, Inc
Devices Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows. Part No. 03.010.523, Lot Nos. 8279162 & 8429004 Class II The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate. Synthes, Inc.
Devices Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients. Model Numbers(s): AO60 and MI60L Class II Lens was manufactured with incorrect raw material. Bausch & Lomb Surgical, Inc.
Food Kinnikinnick Gluten Free Original Homestyle Waffles Frozen Contains a logos on the package indicating it is gluten free, dairy free, and nut free. 210 g/7.4oz Qty/pkg - 6. UPC 62013300198 1. DPI item # 55844. 20131209 and 20131231 Class I DPI Specialty Foods NW is recalling Kinnikinnick Brand gluten free original homestyle waffles because they have the potential to contain the allergen milk, which is not declared on the label. Package contains a logo which indicates the product is dairy free. DPI Specialty Foods Northwest Inc.
Food STEMALIVE, 90 Capsules. The product is in a white plastic bottle with white lid, the brand is StemVida International with a white and gold label. Product labeling reads in part:"STEMVIDA INTERNATIONAL***StemAlive***PROMOTES ADULT STEM CELL FUNCTION AND HEALTH***Dietary Supplement***90 Capsules***Formulated exclusively for STEMVIDA International Corporation 4295 Jurupa St Ste 116, Ontario CA 91741***This exclusively formulated product is only available through ETEMVIDA International independent distributors***www.stemvidainternational.com***". The StemAlive product is shipped as a single unit or in boxes of 4 units or 16 units. The lot numbers and expiration dates are 8419 (Exp.05/2015 and 06/2015), 8486 (Exp.07/2015), 8535 (Exp. 08/2015), 8598 (Exp. 10/2015), 8652 (Exp. 12/2015), 8863 (Exp. 01/2016 and 02/2016), 8872 (Exp. 03/2016), 8873 (Exp. 04/2016 and 05/2016), 9040 (Exp. 08/2016 and 09/2016), 9258 (Exp. 10/2016) and 9314 (Exp. 11/2016). Class I Stemvida International Corporation of Ontario California is recalling certain lots of StemAlive 90 Capsules, because it contains undeclared milk. STEMVIDA INTERNATIONAL INC
Food Kinnikinnick Original Homestyle Waffles Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box UPC: 62013300198 1 lot: 2014AL29 Class I Cal Fresh Produce is recalling Kinnikinnick Foods Original Homestyle Waffles due to undeclared milk. Cal-Fresh Produce
Food Dried Tapioca Pearl, Net Wt. 7oz, 50 bags/carton, UPC Code 0893467803068 n/a Class II Product contains unapproved colors, 16185-Amaranth (E123)-Delisted FD&C Red #2, 45170-Rhodamine B-Basic Violet 10, 42000-Malachite Green-Basic Green 4, 4100-Auramine O-Basic Yellow 2, and undeclared colors FD&C Yellow #5 and FD&C Blue #1. New Japan International, Inc.
Devices GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. FMI 13715 Serial # System ID 00000012391PT9 530UCVETPET 00000012525PT2 RHCDISC710 00000012544PT3 856247PETUPS 00000012561PT7 505216D710 00000012574PT0 858805PCT 00000012615PT1 630432D710 00000012674PT8 801581D710 00000012723PT3 602839D710 00000012732PT4 402327D610 00000012752PT2 719365PETCT 00000012771PT2 414805D710 00000012834PT8 904710PET 00000012843PT9 918505PETCT1 00000012849PT6 205975PET1 00000012865PT2 205975PET2 00000012896PT7 985542D610 00000012915PT5 256386HKPETCT 00000012924PT7 318675D710 00000012937PT9 504842D600 00000012961PT9 303673PETCT 00000012975PT9 605328D710 00000013017PT9 608WIMRD710  ...
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Class II GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your Discovery 600, 610, 710 and Discovery 690. GE Healthcare, LLC
Devices GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station. Parent SN SBG06451608GA SBG06451606GA SBG06451607GA SBG06451638GA SBG06451605GA A4EH1211G A4EH1212G A4EH1251G A4EH1284G A4EH1286G A4EH1287G A4EH1288G A4EH1196G A4EH1197G A4EH1199G A4EH1203G A4EH1204G A4EH1281G A4EH1192G A4EH1193G A4EH1214G A4EH1227G A4EH1228G A4EH1216GR A4EH1219G A4EH1220GR A4EH1291G A4EH1191G A4EH1229G A4EH1230G A4EH1231G A4EH1240G A4EH1245GR A4EH1275G A4EH1264G A4EH1195G A4EH1246G A4EH1247G A4EH1267G A4EH1268GR A4EH1269G A4EH1271G A4EH1200G A4EH1249G A4EH1250G A4EH1254G A4EH1256G A4EH1257G  ...
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Class II GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station: DASH: 1. Dash stops communicating on the Unity Network resulting in Loss of Monitoring at the CARESCAPE" CIC Pro Central Station*. 2. Dash displays distorted ECG waveforms in combination monitoring mode. 3. Dash incorrectly becomes Time Master on the Unity Network®. 4. Dash date reverts to 1993. DASH PORT 2: Dash Port 2 stops communicating on the Unity Network resulting in Loss of Monitoring at the CARESCAPE" CIC Pro Central Station*. *Despite communication loss, the Dash 3000/4000/5000 will continue to provide bedside monitoring including alarms and event storage. GE Healthcare, LLC
Devices Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a hospital information system (HIS). The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures. Model 865471 Lot or serial Numbers: US23200154, US23200155, US23200156, US23200157, US23200158, US23200159, US23200160, US23200161, US23200162, US23200163, US23200164, US23200165, US23200166, US23200167, US23200168, US23200169, US23200170, US23200172, US23200173, US23200176, US23200177, US23200178, US23200179, US23200180, US23200181, US23200182, US23200183, US23200184, US23200185, US23200186, US23200187, US23200188, US23200189, US23200190, US23200191, US23200192, US23200193, US23200194, US23200195, US23200196, US23200197, US23200198, US23200199, US23200200,  ...
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Class II Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Information Portal (Model IP5). Upon power up, the IP5 may fail to produce audio. Invivo Corporation
Devices Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral. part No. 357.399 with all lot numbers 4440270 through 49991803, 5000218 through 5894644, 6000409 through 6999404, 7000143 through 7531836, UK09636, UK10233, UK10510, UL11099, and UL11333. Class II Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label. Synthes, Inc.
Devices Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible. part No. 03.503.043, lot #7908431 Class II One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored band instead of a green colored band as pictured in the Technique Guide. Synthes, Inc.
Devices Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass. Model 78618, Lot numbers: 2011041199, 2011062306, 2011100971, 2011102092, 2011120307, 2012051764, 2012061644, 2012080274, 2012110107, 2012120373, 2013010071, 2013050197, 2013081170, 2013102358, 201203C853. Model 78620, Lot numbers: 2011030255, 2011040939, 2011041341, 2011101160 2011111043, 2012011041, 2012020540, 2012070617, 2012110017, 2012111257, 2013031297, 2013050408, 2013060024, 2013060816, 2013070896, 2013090420, 2013091570, 2013101359. Model 78718, Lot numbers: 2011020219, 2011051461, 2011051501, 2011060279, 2011081265, 2011091551, 2011100022, 2011111305,  ...
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Class II Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. Medtronic Inc. Cardiac Rhythm Disease Management
Devices Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to a molded, clear, flexible PVC tapered body or wirebound PVC body. The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation. The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap. The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line. These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass. Model 78622, Lot numbers: 2011031714, 2011040345, 2011050373, 2011060471, 2011060641, 2011060642, 2011070099, 2011072408, 2011081502, 2011102965, 2011111215, 2011120575, 2012011143, 2012011425, 2012020052, 2012040536, 2012051387, 2012090216, 2012101333 ,2013010957, 2013011791, 2013020303, 2013030729, 2013040209, 2013040282, 2013040710, 2013041272, 2013051447, 2013060736, 2013071836, 2013072009, 201105C105, 201203C854. Model 78722, Lot numbers: 2011031588, 2011031885, 2011051006, 2011051226, 2011061585, 2011071672, 2011082216, 2011091825 , 2011101670,  ...
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Class II Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. Medtronic Inc. Cardiac Rhythm Disease Management
Devices Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to a molded, clear, flexible PVC tapered body or wirebound PVC body. The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation. The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap. The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line. These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass. Model 78624, Lot numbers: 2011010432, 2011010514, 2011010515, 2011011141, 2011011543, 2011021907, 2011040344, 2011040946, 2011060613, 2011060865, 2011070535, 2011071749, 2011081635, 2011110330, 2011120304, 2011120305, 2011121133, 2012060424, 2012060431, 2012070886, 2012080324, 2012081353, 2012081928, 2012090013, 2012120521, 2012121021, 2012121414, 2013031142, 2013050555, 2013050805, 2013051225, 2013051640, 2013060249, 2013090499, 2013090570, 2013091332, 2013091924, 201106C140, 201203C844, 201310C579. Model 78724, Lot numbers: 2011032145, 2011050718, 2011060852,  ...
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Class II Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. Medtronic Inc. Cardiac Rhythm Disease Management
Devices Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to a molded, clear, flexible PVC tapered body or wirebound PVC body. The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation. The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap. The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line. The proximal end features a pressure monitoring line with a 3-way stopcock. These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass. Model 78818, Lot Numbers: 2011021826, 2011070534, 2011090245, 2011110207, 2011111844. Model 78820, Lot Numbers: 2011062305, 2011072337. Model 78822, Lot Number: 2011011178 Model 78920, Lot Numbers: 2011050717, 2011082464, 2011120308, 2012070891, 2012071268, 2013081135, 2013121551, 201106C038. Model 78922, Lot Numbers: 2011011187, 2011020121, 2011020785, 2011021532, 2011070801, 2011081266, 2011090483, 2012012160, 2012021436, 2012021695, 2012071735, 2013010416, 2013030273, 2013050807, 2013051036, 2013070174, 2013091410, 2013101028,  ...
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Class II Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. Medtronic Inc. Cardiac Rhythm Disease Management
Devices Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae has clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass. Lot numbers: 12259014, 206292900, 12011874, 12286525, 12086013, 06867511, 206784461. Class II Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. Medtronic Inc. Cardiac Rhythm Disease Management
Devices Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified by the user. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures. Model 3Y90R3, Lot numbers: 12227513, 12277464, 206420618, 206618641, 206842458, 206932996, 207184816. Model C300901B, Lot number 206499164. Class II Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. Medtronic Inc. Cardiac Rhythm Disease Management
Food Mega Slim Herbal Appetite Management, 30 Capsules Bottle. Product labeling reads in part:"MEGASLIM Herbal Appetite Management***30 Capsules***YoungYou Weight Loss Center***MegaSim Propriety Blend 590 mg, Garcinia Cambogia Extract, Green Tea, Aloe Ferox, L-Carnitine, Caralluma fimbriata Extract***Distributed by YoungYou International Inc. Earth Creation, USA (877) 496-8649 www.youngyoucorp.com***". No Lot Codes. Product sold/distributed September 15, 2013 through January 23, 2014. UPC code 7 36211 61409. Expiration date June 2014. Class II YoungYou International is voluntarily recalling Mega Slim Herbal Appetite Management, 30 capsules, sold from September 15, 2013 through January 23, 2014, because it was found to contain DMAA. YoungYou International Inc
Devices Integra Cusa Excel Rx Only CEM" Nosecone for CUSA® Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently. All unexpired lot numbers for CEM Nosecone Gatalouge No. C6623 and C6636 from 1/1/2010 to present. CEM" Nosecone, Catalogue No. C6623: 1083655, 1084219, 1084398, 1084399, 1084400, 1084682, 1084683, 1090937, 1091712, 1091714, 1091715, 1093125, 1093126, 1093128, 1093129, 1093471, 1093847, 1094575, 1094740, 1095587, 1095873, 1100237, 1100238, 1101217, 1101547, 1101548, 1102069, 1102070, 1102544, 1102545, 1102546, 1103102, 1103392,  ...
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Class II The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position. Integra LifeSciences Corp.
Food Mid Pac Foods brand sauce for Char Sui; Net 7 FL. oz (207 ml); Made in Hawaii, Keep in cool place UPC: 7336620250 Manufactured by Mid Pac Foods, Inc. Honolulu, HI. Lots 10204 and 10247 Class II Inspection at firm found that sauce for Char Siu declares Hoisin sauce as an ingredient, but does not declare the sub ingredient of wheat. Mid Pac Foods, Inc.
Devices Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary. Catalog Number SLV634, Lot Number 852766. Class II Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro closure. Implantech Associates Inc
Food IQF Stuffed Brined Jalapeno Peppers w/Gorgonzola Allergen: Milk, Wheat. Prod.Code: 4013 24/30 lb bags - 720 lb totes Keep Frozen Bin# Comarco Products 501 Jackson Street, Camden, NJ 08104 Lot 4013 -R46500001 Class II Gorgonzola stuffed jalapeno peppers tested positive for Listeria monocytogenes. Comarco Products, Inc.
Devices MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature. Catalog number MAP690; Lot numbers 01162 and 01186. Class II Tyvek packaging may be worn, causing loss of package integrity. Biocardia, Inc.
Devices CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLUOROSCOPIC CAPTURES ARE INTEGRATED INTO THE CART0 3 SYSTEM MAP VIEWERS (MAP VIEWER AND ADDITIONAL VIEW), CART0 3 MAPS, MRl OR CT IMAGES, AND CATHETER VISUALIZATION ARE SUPERIMPOSED ON THE FLUOROSCOPIC CAPTURE. Serial No. 13201, 11125, 11519, 11320, 11115. Class II Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only. If the table rotation is not returned to zero point, there is a misalignment between the Carto 3 System map display and the fluoroscopic capture. Biosense Webster, Inc.
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