Source: http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=02262014
Timestamp: 2014-10-25 18:26:31
Document Index: 400781310

Matched Legal Cases: ['art 1', 'art 2', 'arto 3', 'ART0', 'ART0', 'ART0', 'arto 3', 'arto 3']

Enforcement Report - Week of February 26, 2014
102713647
102713647; 102713647
GF01233
104181146
Blood products, collected from a donor who was taking the drug Methotrexate, were distributed.
GY10019
107977875- part 1;107977875- part 2;107977882
Blood products, which were out of controlled storage temperatures, were distributed.
103337718
W126108008515
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.
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
Donor Screening/Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked
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 ...More
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.
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 ...More
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 ...More
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 ...More
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 ...More
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
60807850
60855077
60143351
60384033
60632720
60807851
60219007
60740783
60993433
60539739
60807852
60241936
60625494
60082810
60625506
60222477
60109715
60187232
60161891
60116180
60175536
60082811
60109716
60123966
60175537
60231394
60097992
60119110
60143352
60165702
60109717
60112053
60116181
60116182
60129316
60129317
60154512
60175539
60187233
60187234
60206859
60241934
60161892
60109718
60123968
60082812
60109719
60163222
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 ...More
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 ...More
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 ...More
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 ...More
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 ...More
ASIA ONE-PIECE LAG SCREW 61671102
62142296
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 ...More
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 ...More
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 ...More
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 ...More
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 ...More
MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001
60101997
60202868
60202869
60257213
60261647
60266457
60273995
60273996
60324337
60411690
60411691
60428980
60457742
60474620
60474622
60646263
60646264
60646265
60708475
60797297
60822088
60867060
60899017
60899018
60945798
61104294
61199990
61222220
61282924
61320383
61336983
61336985
61522992
61550876
61555656
61664260
60065984
60135098
60135109
60179688
60242116
60242117
60273997
60294371
60345749
60457743
60600426
60646268
60708476
60803408
60846356
60899019
60945799
61172283
61199988
61282925
61320379
61339628
61460816
61550877
61664258
60242118
60428996
60474623
61222221
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 ...More
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
60579385
60756651
61887830
60105629
60166064
60224275
60337906
60586318
60595606
60696728
60808905
61018586
61180337
61249355
61341882
61526208
61636571
61717191
61887831
61929703
62048813
60213807
60331257
60579387
60941524
61233952
61687333
60099537
60139269
60194156
60244942
60436638
60614725
60681999
60945765
61089048
61207434
61378442
61585149
61770493
60191625
60610790
60858860
61180338
61770494
60209213
60579392
61089049
61378443
61902190
60503470
60678795
60897195
61770495
60230948
60420518
60676026
61056150
61445351
60330149
60504976
60671244
60897209
61146352
61770496
60294720
60503550
61018587
60233993
60501971
60834361
61160767
60105632
60503494
60586320
60595609
61238563
60125012
60504978
61265359
60266112
60860053
61207435
60209212
60382121
60671248
61070792
61238565
61497083
60099538
60395058
60503554
60682001
61228341
61266850
60367469
60858861
61207436
60310132
60491634
60671251
60105634
60213808
60330152
60461447
60652031
61180339
61422287
60135104
60194157
60266113
60334482
60436657
60503483
60834366
61146353
61445352
62143506
60213809
60330153
60965138
61504824
60263493
60858859
61331581
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 ...More
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 ...More
MODULAR CUP NEUTRAL LINER
MODULAR CUP 10 DEGREE LIN
MODULAR CUP 20 DEGREE LIN
MODULAR CUP 7MM OFFSET LI
61547919
61954158
61241463
62188365
61564304
60919205
61666604
60928241
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
61892712
61901662
60668061
61584777
61059234
61403759
60497031
61303608
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
61072064
61160052
61261860
61642713
61722445
62296659
60715034
61018915
61036921
61136634
61179946
61377132
61504792
61564330
61598593
61652828
61662223
61746897
61885964
62062927
62166312
62167440
60611465
61121730
61491274
61542625
62170707
62296657
61138050
61509276
61591304
61662225
61751908
61875723
61902216
62113239
62183216
62322488
60715040
62134061
61407093
61509275
61564339
61598601
61751904
61928945
62183217
62292053
62330877
61403906
60699177
61591302
62127617
62301528
61504789
61698789
62109142
62296661
61261880
61403757
62123083
60595588
61407096
61633829
61788072
62296663
60593824
60841777
61424558
62268509
61509269
61580668
61631807
62330880
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
61478415
62330884
61110936
61675948
61138057
62301533
60717011
60611470
60656941
60863743
62330885
60715052
61287001
61751907
62296665
62327789
61651457
62292056
60862307
62077408
62180255
62296658
62000454
62127618
61651453
61547925
60612264
62123082
61224783
60595598
61652830
61005427
60584587
61547937
60643575
60885073
61623060
60885074
61641918
61241575
61261913
61643326
60642954
61457271
60676424
60767532
61436014
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 ...More
HGP II ACETABULAR CUP BON
60623443
61033908
60735135
60134455
60752636
60843726
61056222
60507678
60849459
60746629
60373606
60621446
60696755
60796167
60884344
61138012
61202414
61336976
61445414
61479406
61614837
61830570
62081013
62130755
62204493
60358198
60456662
60676065
60740508
60847420
60970346
61018601
61089082
61114463
61197927
61265392
61336977
61405285
61445415
61504347
61560488
61612779
61717244
61830571
62017892
62081014
62126660
62161132
62194338
62286121
60096604
60191638
60231058
60310154
60403566
60541147
60614769
60652079
60771842
60809040
60906712
60965173
61013603
61077260
61191847
61197928
61288037
61336979
61445416
61504866
61548952
61612780
61738511
61830572
61902195
61902196
62017893
62048834
62090584
62204494
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
62130756
62194340
62211466
62315402
60307754
60358199
60745919
60817921
60884347
60932061
61013580
61077263
61197929
61283948
61354050
61445417
61458847
61612782
61649249
61738514
61770505
61830569
61906698
61948762
62104332
62130758
62227608
62308540
60391769
60537584
60614771
60780619
60906713
60965175
61056224
61120060
61180329
61226933
61283949
61336980
61405288
61445418
61479405
61573709
61623853
61674477
61717245
61760696
61770506
61830575
61902204
62104333
62143479
62308549
60354639
60400189
60503574
60535463
60604758
60616222
60642282
60687795
60756662
60796168
60821835
60875850
60909007
61035977
61089087
61180330
61202417
61255507
61296294
61378483
61445419
61458849
61504867
61649255
61674478
61717246
61770507
61770508
61902205
61906700
62061649
62194341
62227610
62308555
60503575
60621432
60745920
60821836
60897238
60970356
61056225
61120022
61197933
61331593
61612777
61672382
61770509
62017898
62204495
HGP II ACETABULAR CUP MOD
60035657
60035663
60163301
60078959
PRESSFIT FEM ST FX 16 X 1
60667768
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
61640544
61727080
61795011
61803866
61830030
61841636
61841637
61859438
61860472
61878469
61880368
61903233
61936199
61980174
62024623
62055989
62055991
62097061
62106808
62143853
62147329
62147330
62199399
62213245
62232590
62240777
62268582
62268583
62298293
62305944
61282966
61727082
61962092
61189806
61266267
61294351
61293625
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 ...More
ZIMTRON 6 DEG 22 HEADS
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 ...More
CPT 12/14 COCR (various sizes)
60274775
60310767
60398002
60491038
60638468
60638470
60685165
60776190
60797319
60927586
61189804
61237349
61342952
61468762
61490103
61596784
61748948
61764725
61840597
61917999
61964635
61999588
60261761
60261763
60776227
60776234
60846362
60916726
60952935
60979483
61162865
61189800
61356814
61460831
61739387
61748949
61829563
61996730
60310780
60335521
60412478
60457571
60533531
60776287
60776288
60823773
60990055
61045309
61351320
61500146
61727738
61957411
60217292
60330281
60448728
60491098
60648441
60704737
60776312
60952946
61261797
61293863
61307997
61733348
61758312
61868121
61881187
61885896
61991679
60245153
60323912
60372490
60589471
60704749
60723802
60748790
60921196
60957269
61045290
61061843
61104280
61114610
61733350
61987756
61991676
60217518
60310793
60589477
60829712
60957183
60957252
61010390
61047782
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
61516824
61596779
61744474
61833302
61878466
61930418
61964629
60310799
60352497
60600588
60615058
60748834
60797333
60823790
60889814
60889815
60952953
60957186
61045316
61325399
61351344
61522157
61694927
61762060
61815831
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
60443946
60491173
60685261
60809480
61024361
61516832
61607601
60378595
60723862
60748854
60748855
60898910
61045291
61114614
61211994
61505499
61512550
61814507
61914812
61987765
60200828
60225125
60274811
60660270
60685253
60723871
60822510
60842663
60889819
60889820
61027639
61061835
61182969
61282937
61314041
61460835
61490099
61696376
61731630
61809118
61987773
62017570
60217523
60274812
60420451
60517574
60704827
60723878
60749232
60789777
60809481
60809482
60898877
60927619
60927620
60979509
61045318
61173152
61205952
61216685
61505498
61650364
61744461
61762059
61833301
62005396
60491175
60704843
60789778
60799619
60880782
60997430
61546126
60324107
60443947
60704844
60724240
60809483
60921203
61114628
61601357
60491179
60820144
61061846
61290086
61691513
60225115
60330349
60723884
60723885
60809484
61027640
61061855
61500145
61817968
61927037
60510237
60510239
60704831
60749247
60749248
60820124
60858530
60889822
60990042
60990043
61006802
61045292
61094975
61114629
61316307
61354857
61647194
61696371
61744471
61820815
60222666
60274815
60510242
60660275
60704835
60749255
60749256
60944307
60973154
60979538
61024369
61062535
61114616
61153032
61339722
61550881
61683768
61696359
61779345
61820816
60225128
60704836
61024371
61490101
61790493
60704845
60803456
60789779
61664275
60704715
61035926
61325390
61636260
61762068
60809444
61061836
61297358
61473756
61522154
61589113
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 ...More
6 DEGREE COCR FEM HEAD 36
60308845
60508319
60588077
60670902
60701935
60779840
60810357
61077837
61191243
61191244
61247015
61304729
61340542
61401735
61485227
61551614
61555020
61670831
61720512
61774878
61790557
62025229
62124070
62176438
60339031
60407279
60586160
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
62025230
62176441
62284369
60339030
60392901
60440343
60508338
60656885
60669433
60779866
60779867
60790102
60806209
60847646
61052834
61077841
61144531
61191245
61304736
61401737
61485225
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
61002278
61077842
61304741
61340544
61424894
61485226
61618473
61676503
61713708
61779846
61790560
62025233
62093451
62176446
62218173
60439652
60515401
60593679
60884548
60940020
61018982
61077843
61081687
61191241
61224849
61459434
61535709
61618470
61683763
61720514
61774871
61779847
61837161
61896795
62025234
62098854
62099285
MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID 60169597
60096116
60096117
60134409
61059560
60096118
60553617
60743729
60990038
61298521
60096119
60411949
60540531
60609946
60700469
61657255
60110443
60154855
60187556
60301871
60484369
60716272
60768572
60887301
61211680
61304669
61589078
61619986
60096121
60169413
60242838
60540735
60565849
60610009
61401537
61694181
61878452
61934378
60109037
60110290
60124913
60326542
60423101
60484409
60768593
60845456
61199171
61298517
61613251
61817985
61992516
60096125
60110448
60148883
60242895
60484704
60540826
60737211
61103540
61324218
61619209
61659604
61758278
61817987
60109039
60124924
60169479
60187599
60242901
60293321
60335415
60442118
60506747
60993378
60993379
61118585
61276626
61398796
61651794
61756168
61758280
60096126
60187653
60412010
60574597
60787916
61118586
61932403
60187682
60274760
60423134
61231910
61651793
61837093
60096127
60355236
60565935
61976171
60148884
60484813
61042186
61290074
61528630
61744433
60301911
60541000
61059561
61555631
61658313
60395295
60900095
61324217
60541001
61370524
60096186
60553915
60096187
60096188
60096190
60301876
60906529
60169412
60326978
60484392
61895487
60099418
60242846
60506729
60096193
60523403
60331362
61222214
60906530
61886563
60484817
61886564
60423158
60906531
60096202
60331367
60101998
60101999
60145797
60156493
60178358
60187897
60213589
60274027
60284125
60284126
60294382
60382721
60411695
60467652
60474624
60614956
60708479
60822078
60822089
60899020
61092517
61104296
61199985
61243392
61282926
61293847
61336987
61435528
61664257
61696348
60135105
60156495
60156496
60178359
60187902
60222247
60234255
60273998
60275695
60294383
60313730
60313732
60345750
60382722
60411698
60457745
60474626
60535059
60551516
60589262
60708480
60793770
60822079
60822090
60876799
60899021
61092518
61172276
61172277
61199987
61263822
61282922
61293846
61435527
61460812
61522994
61550878
61696349
60145802
60187905
60324336
60429016
60474629
60803409
CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
60089260
60145841
60089259
60156459
62135079
62079190
60732916
60638837
62094973
61887194
60457227
FEM HD ION (various sizes)
60282649
60291491
60362702
60586125
60977398
61089134
62051714
60530561
60759915
60939995
61275826
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 ...More
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 ...More
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
61251341
61168825
61216588
61247526
61216589
61247527
61168829
61247528
61168830
61216591
61247529
61168831
61247530
61168833
61216593
61247531
61168835
61247532
61168837
61216596
61247533
61168839
61168841
61168842
61168843
61168845
61168847
61223705
61168849
61168850
61168854
61168856
61168859
61168860
61168861
61567437
61411579
61678383
61835910
61835909
61216599
61214650
61216602
61251346
61216605
61591005
61190532
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61823977
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61560427
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61401998
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61740552
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61740553
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61190641
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61190643
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
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61173341
61115956
61173344
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61359816
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 ...More
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
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
61804309
61173207
61173208
61117130
61173210
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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, ...More
Digestive enzyme capsules manufactured by NOW Foods may contain the antibiotic chloramphenicol.
Tray/Kit SPPT-5F-10/D, Lot # T491273 , Exp. 31-Dec-2014, SPPT-5F-10/D, Lot # T512967, ...More
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.
Access 2 Immunoassay System Analyzer. K922823/A007.
Part Number 81600N.
Serial Numbers 508957,
508963,
508964.
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.
UniCel DxI 600 Access Immunoassay System Analyzer. K023764.
Part Number A30260.
Serial Numbers 900781.
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.
Superstand stand-up wheelchair
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, ...More
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.
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
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
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
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.
W036811805704; Class II
W036811074718; Class III
Blood products, collected from a donor whose suitability to donate was not adequately determined, was distributed.
W036213722644; Class III
Blood product, with insufficient red cell preservative solution added, was distributed.
W204113003575; Class III
W117013545858; Class II
Blood product, which was not prepared according to specifications, was distributed. Blood Centers of the Pacific - Irwin Center
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
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
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
The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
Lots 2273, 2283, 2343, 2603, 2633, 2703, 2743, 2883
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
Potential collision risk when using XVI and external beam shaping devices.
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
XVI can incorrectly calculate the target position of the treatment table.
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
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
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 ...More
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.
Siemens Prisma 2K Hearing Aid
A behind the ear (BTE) hearing aid developed for pediatric patients.
1) 7773182
2) 7244028
3) 8757374
4) 8747086
5) 10056937
6) 10056938
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.
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
The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate. Synthes, Inc.
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
Lens was manufactured with incorrect raw material.
DPI item # 55844.
20131209 and 20131231
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.
STEMALIVE, 90 Capsules.
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
lot: 2014AL29
Cal Fresh Produce is recalling Kinnikinnick Foods Original Homestyle Waffles due to undeclared milk.
Dried Tapioca Pearl, Net Wt. 7oz, 50 bags/carton, UPC Code 0893467803068 n/a
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.
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 ...More
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, 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 ...More
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.
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, ...More
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
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.
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
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.
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, ...More
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
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, ...More
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, ...More
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, ...More
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.
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.
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.
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.
Integra Cusa Excel Rx Only
CEM" Nosecone
for CUSA® Excel System
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, ...More
The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.
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.
Lots 10204 and 10247
Inspection at firm found that sauce for Char Siu declares Hoisin sauce as an ingredient, but does not declare the sub ingredient of wheat.
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.
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.
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
Gorgonzola stuffed jalapeno peppers tested positive for Listeria monocytogenes.
Comarco Products, Inc.
MORPH ACCESSPRO Steerable Introducer;
6F introducer, 90 cm working length:
Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic:
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.
Tyvek packaging may be worn, causing loss of package integrity.
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.