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U.S. Department of Health and Human Services

Class 1 Device Recall Infusomat Administration Sets

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 Class 1 Device Recall Infusomat Administration Setssee related information
Date Initiated by FirmNovember 01, 2023
Date PostedDecember 01, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0355-2024
Recall Event ID 93232
510(K)NumberK142036 
Product Classification Set, administration, intravascular - Product Code FPA
ProductInfusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL, length: 120in, SafeLine; 362035 INFUSOMAT SPACE PUMP IV SET; 362043 Priming volume: 39mL, length: 120in, SafeLine; 362050 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine; 362420 SPACE PUMP SET 15 DROP W/2 SAFEDAY; 362432 15 drops/mL, priming volume: 21mL, length: 118in, ULTRASITE; 362911 Priming volume: 14mL, length: 84in, CARESITE, Spin-Lock; 363010 Priming volume: 21mL, length: 121in, SafeLine; 363019 Priming volume: 40mL, length: 123in, SafeLine; 363030 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 363032 20 drops/mL, priming volume: 20mL, length: 119in, SafeLine; 363230 15 drops/mL, priming volume: 22mL, length: 123in, ULTRASITE; 363410 15 drops/mL, priming volume: 23mL, length: 119in, CARESITE; 363419 Priming volume: 41mL, length: 120in, CARESITE; 363420 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; 363421 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 363422 Priming volume: 21mL, length: 130in, CARESITE; 363423 60 drops/mL, priming volume: 21mL, length: 118in, CARESITE; 363424 UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; 363430 15 drops/mL, priming volume: 23mL, length: 123in, CARESITE; 363433 UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; 363901 60 drops/mL, priming volume: 11mL, length: 129in; 363902 Priming volume: 25mL, length: 130in; 363904 UNIV. 15 DROP PUMP SET, ASV; 470119 15 drops/mL, priming volume: 23mL, length: 119in, CARESITE; 480254 SPACE PUMP IV SET 15D, 110 IN.; 480255 SPACE PUMP IV SET, 127 IN; 480257 60 DROP NITRO SPACE SET, 88 IN.; 480258 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; 480263 SPACE PUMP IV SET 15D, 90 IN.; 480264 SPACE PUMP IV SET, 15 DRPS/ML, 95 IN.; 490037 Priming volume: 25mL, length: 136in; 490038 60 drops/mL, priming volume: 11mL, length: 129in; 490100 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 490101 Priming volume: 19mL, length: 120in, CARESITE; 490102 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 490103 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; 490104 60 drops/mL, priming volume: 21mL, length: 115in, CARESITE; 490105 Priming volume: 39mL, length: 120in, CARESITE
Code Information Material No. 362031 UDI-DI 04046964837807 Lots: 0061809812 0061822006 0061826547 0061842006 0061844316 0061850548 0061863075 00VL881443 00VL881444 00VL881445 Material No. 362032 UDI-DI 04046964182556 Lots: 0061825440 0061826518 0061841107 0061859898 0061891206 00VL881446 00VL881447 00VL881448 Material No.362033 UDI-DI 04046964837821 Lots: 0061825491 0061832933 0061841016 0061844319 0061852088 0061859899 0061861528 0061880107 0061888294 0061891613 0061900150 Material No. 362034 UDI-DI 04046964182570 Lots: 0061809813 0061875347 0061880110 0061895436 00VL845496 Material No. 362035 UDI-DI 04046964699047 Lots: 0061815242 0061820766 0061821992 0061821993 0061826531 0061829597 0061831769 0061832958 0061844310 0061847255 0061853102 0061855700 0061863625 0061888327 0061894407 Material No. 362043 UDI-DI 04046964182631 Lots: 0061863076 362050 04046964182655 0061822091 0061840508 0061852666 0061861244 00VL881402 00VL881403 00VL881404 Material No. 362420 UDI-DI 04046955592715 Lots: 0061822004 0061823035 0061823071 0061826688 0061831761 0061837001 0061837884 0061837891 0061842996 0061843033 0061847222 0061849999 0061855839 0061855840 0061859988 0061859990 0061859991 0061874588 0061876229 0061880059 0061883209 0061885064 0061888323 0061891571 0061892316 0061895535 0061895682 0061898768 0061898950 00VL880878 00VL882007 00VL882008 Material No. 362432 UDI-DI 04046964182679 Lots 0061806560 0061864982 Material No. 362911 UDI-DI 04046964837845 Lots 0061829592 0061847275 0061852087 0061855702 0061859902 0061868581 0061876580 0061878508 0061880060 00VL866594 00VL866595 00VL866596 Material No. 363010 UDI-DI 04046964294174 Lots 0061815475 0061822081 0061841080 0061852668 0061863624 0061875604 Material No. 363019 UDI-DI 04046964294198 Lots 0061818130 0061832938 0061865704 Material No. 363030 UDI-DI 04046964294259 Lots 0061815476 0061838037 0061851854 0061864873 0061892484 0061895683 00VL817533 00VL817534 Material No. 363032 UDI-DI 04046964294297 Lots 0061815254 0061817792 0061836642 0061841018 0061847266 0061859903 0061882707 0061895431 0061900141 00VL865134 00VL865135 00VL865136 Material No. 363230 UDI-DI 04046964294495 Lots 0061823073 0061826527 0061829582 0061837002 0061844306 0061855699 0061862022 0061875596 0061876683 0061882709 0061885068 0061894394 0061901576 00VL867493 00VL867494 00VL867495 Material No. 363410 UDI-DI 04046964294556 Lots 0061816472 0061821960 0061829599 0061841019 0061846809 0061853103 0061859904 0061872871 0061879899 0061895432 0061901579 Material No. 363419 UDI-DI 04046964294570 Lots 0061815247 0061819597 0061822034 0061823076 0061826505 0061837003 0061852675 0061854000 0061854058 0061859905 0061862023 0061863609 0061865591 0061869283 0061875291 0061877613 0061877614 0061891634 00VL831041 00VL831042 00VL831043 00VL890369 00VL890370 00VL890371 Material No. 363420 UDI-DI 04046964294594 Lots 0061818061 0061823079 0061829586 0061837004 0061844308 0061855701 0061861240 0061868575 0061874532 0061885035 Material No. 363421 UDI-DI 04046964294617 Lots 0061811559 0061814341 0061815238 0061817977 0061817988 0061819668 0061821991 0061823068 0061825476 0061825478 0061826194 0061826501 0061826502 0061826683 0061827330 0061828023 0061829580 0061830091 0061831739 0061832096 0061833564 0061837005 0061837006 0061837007 0061837892 0061841117 0061842994 0061843029 0061844303 0061845291 0061847169 0061847170 0061850000 0061850532 0061850540 0061851939 0061853106 0061855697 0061855830 0061855831 0061855832 0061855833 0061858279 0061858284 0061859442 0061859663 0061859950 0061859952 0061860125 0061861840 0061862010 0061864612 0061870697 0061870720 0061870721 0061870750 0061870848 0061870849 0061875466 0061876678 0061879942 0061879963 0061880063 0061880088 0061880101 0061883210 0061887529 0061888288 0061888326 0061891632 0061891645 0061892039 0061894272 0061894273 0061894274 0061895684 0061896879 0061901583 0061901584 Material No. 363422 UDI-DI 04046964294631 Lots 0061815266 0061859730 0061882161 0061891576 00VL817535 00VL866368 Material No. 363423 UDI-DI 04046964294655 Lots 0061815478 0061832935 0061837009 0061844317 0061863077 0061873206 0061885065 0061891577 Material No. 363424 UDI-DI 04046964837906 Lots 0061815480 0061822066 0061826553 0061833595 0061841020 0061846766 0061852672 0061861524 0061870722 0061876834 0061890407 0061901588 Material No. 363430 UDI-DI 04046964294679 Lots 0061811558 0061815235 0061815482 0061816435 0061816796 0061817978 0061817993 0061817994 0061818676 0061821595 0061821987 0061821988 0061823069 0061826499 0061826686 0061827329 0061829577 0061831759 0061832974 0061833566 0061837010 0061837011 0061837012 0061837303 0061837893 0061838870 0061841083 0061841110 0061842992 0061843027 0061844304 0061845289 0061847042 0061847171 0061847172 0061847173 0061848289 0061848662 0061849508 0061850001 0061850330 0061850533 0061850547 0061850626 0061853107 0061853143 0061855835 0061855836 0061855837 0061855838 0061856842 0061856843 0061858164 0061858283 0061859228 0061859444 0061859912 0061859944 0061859946 0061859947 0061860121 0061860122 0061860863 0061861839 0061862002 0061862498 0061865302 0061866000 0061869278 0061869381 0061869386 0061870725 0061870726 0061870850 0061870852 0061871267 0061876676 0061876679 0061877002 0061877512 0061879881 0061879882 0061879964 0061880064 0061880090 0061880241 0061880243 0061883211 0061883582 0061885062 0061887080 0061888453 0061891617 0061894396 0061894402 0061895663 0061895831 0061895832 0061897187 0061899940 0061901589 0061901590 0061902095 00VL885536 00VL885537 00VL885538 Material No. 363433 UDI-DI 04046964837920 Lots 0061815484 0061822042 0061826551 0061841021 0061852667 0061862536 0061891578 0061895410 0061898734 00VL851146 00VL851147 00VL851148 Material No. 363901 UDI-DI 04046964294716 Lots 0061818804 0061861261 0061863628 0061891579 0061898773 Material No. 363902 UDI-DI 04046964294730 Lots 0061814358 0061820767 0061822011 0061829591 0061843401 0061855824 0061866016 0061879922 0061888263 00VL862530 00VL862531 00VL862532 Material No. 363904 UDI-DI 04046964699061 Lots 0061819595 0061824861 0061835511 0061837015 0061843000 0061847230 0061855825 0061862025 0061866010 0061873207 0061876025 0061876420 0061891570 0061891637 0061895443 0061898775 00VL865910 00VL865911 00VL865912 Material No. 470119 UDI-DI 04046964298714 Lots 0061823046 0061833291 0061833546 0061844318 0061883002 0061888319 00VL855548 00VL855549 00VL855550 Material No. 480254 UDI-DI 04046955324798 Lots 0061812951 0061812953 0061820106 0061820768 0061823072 0061825485 0061827900 0061830164 0061838275 0061855847 0061863078 0061863645 0061867150 0061876581 0061879097 0061879921 0061881414 0061885059 0061889916 0061900325 0061901361 00VL844669 00VL852455 00VL852456 00VL852457 Material No. 480255 UDI-DI 04046955324804 Lot 0061897302 Material No. 480257 UDI-DI 04046955324828 Lots 0061820769 0061826079 0061826528 0061843406 0061865427 0061873209 0061887372 0061888287 00VL836623 00VL836624 00VL836625 00VL857207 00VL857208 00VL857209 Material No. 480258 UDI-DI 04046955324835 Lots 0061815489 0061824599 0061829587 0061850550 0061861239 00VL847051 00VL847052 00VL847053 Material No. 480263 UDI-DI 04046955693931 Lots 0061874472 0061888448 0061894265 0061900139 Material No. 480264 UDI-DI 04046955778744 Lots 0061871461 0061872801 0061894264 0061898761 Material No. 490037 UDI-DI 04046964185922 Lots 0061825492 0061832970 0061837017 0061843413 0061847236 0061852663 0061858285 0061862021 0061870727 0061874590 0061877625 0061885070 0061898771 00VL835478 00VL835479 00VL835480 Material No. 490038 UDI-DI 04046964185946 Lots 0061826523 0061836898 0061843414 0061850530 0061895022 0061895023 0061895024 0061900137 00VL891503 Material No. 490100 UDI-DI 04046964186080 Lots 0061814343 0061814994 0061815236 0061815493 0061816436 0061816798 0061816862 0061817574 0061817575 0061817979 0061817980 0061817996 0061817997 0061817998 0061818438 0061818439 0061818455 0061819064 0061819551 0061819699 0061819700 0061820703 0061821596 0061821597 0061821598 0061821599 0061821983 0061821984 0061821985 0061822585 0061822586 0061822891 0061822892 0061822894 0061823030 0061823067 0061824460 0061824461 0061824462 0061824463 0061824594 0061825229 0061825230 0061825379 0061825482 0061825757 0061826026 0061826191 0061826192 0061826193 0061826496 0061826497 0061826682 0061827324 0061827326 0061827353 0061828019 0061828020 0061829576 0061830088 0061830089 0061830090 0061830883 0061831121 0061831122 0061831677 0061831678 0061831679 0061831732 0061831733 0061831850 0061832098 0061832099 0061832100 0061832101 0061832978 0061833561 0061833562 0061833969 0061834646 0061834647 0061834648 0061835418 0061835419 0061835420 0061835421 0061836361 0061836362 0061836363 0061836364 0061836627 0061837019 0061837020 0061837021 0061837022 0061837023 0061837024 0061837025 0061837026 0061837027 0061837298 0061837299 0061837300 0061837301 0061837894 0061838869 0061841116 0061842866 0061842867 0061842991 0061843026 0061844301 0061845035 0061845290 0061847040 0061847041 0061847174 0061847175 0061847176 0061848287 0061848661 0061849512 0061850002 0061850323 0061850324 0061850534 0061850538 0061850622 0061850667 0061851933 0061852394 0061852500 0061853139 0061853140 0061853490 0061853491 0061853900 0061854180 0061854483 0061854484 0061854485 0061854486 0061855757 0061855826 0061855827 0061855828 0061855829 0061856050 0061856051 0061856714 0061856715 0061856845 0061856846 0061857204 0061857684 0061858277 0061858282 0061858742 0061858743 0061858744 0061859432 0061859433 0061859434 0061859664 0061859939 0061860117 0061860119 0061860864 0061860865 0061861498 0061861499 0061861772 0061861835 0061861901 0061861997 0061861998 0061861999 0061862000 0061862491 0061862492 0061862493 0061862494 0061862627 0061863081 0061863082 0061863083 0061863084 0061863780 0061863781 0061866020 0061866487 0061867583 0061867659 0061868583 0061869277 0061869546 0061869547 0061869548 0061870695 0061870732 0061870733 0061870739 0061870740 0061870741 0061870742 0061870836 0061870837 0061870838 0061870839 0061870840 0061871264 0061871265 0061871266 0061871684 0061872019 0061872020 0061872021 0061872617 0061873211 0061873212 0061873213 0061873269 0061875343 0061875463 0061875464 0061875465 0061875889 0061876297 0061876671 0061876682 0061877494 0061877495 0061878601 0061878602 0061878603 0061878604 0061878945 0061879941 0061879965 0061880065 0061880086 0061880087 0061880089 0061880094 0061880237 0061880238 0061880239 0061880281 0061880699 0061880700 0061880701 0061880902 0061880903 0061880953 0061881637 0061881688 0061882036 0061882212 0061882923 0061882924 0061882925 0061882926 0061882987 0061883080 0061883201 0061883212 0061883573 0061883574 0061883575 0061883576 0061884155 0061885073 0061885363 0061885664 0061885665 0061886217 0061886221 0061887032 0061887033 0061887069 0061887463 0061887464 0061887816 0061887817 0061887818 0061887819 0061888325 0061888451 0061888649 0061888650 0061888674 0061888900 0061888986 0061889342 0061889343 0061889344 0061890427 0061890595 0061890596 0061890935 0061890985 0061891614 0061891647 0061892031 0061892032 0061892033 0061892034 0061892126 0061892127 0061893511 0061893512 0061893513 0061893514 0061893523 0061894132 0061894133 0061894134 0061894135 0061894398 0061894495 0061895354 0061895355 0061895356 0061895357 0061895696 0061895836 0061895837 0061895838 0061895839 0061895840 0061897232 0061897233 0061898943 0061898961 0061899167 0061899635 0061899636 0061899637 00VL843258 00VL843260 00VL843262 00VL844674 00VL844675 00VL845499 00VL845500 00VL847389 00VL848417 00VL849200 00VL850011 00VL852461 00VL852462 00VL852463 00VL857023 00VL857024 00VL857199 00VL864167 00VL879122 00VL879123 00VL879124 00VL887228 00VL887229 00VL887230 Material No. 490101 UDI-DI 04046964186103 Lots 0061836643 0061852089 0061859908 0061865711 0061879873 0061879966 0061883202 0061888317 0061898681 00VL841919 00VL843987 00VL844536 Material No. 490102 UDI-DI 04046964186127 Lots 0061814344 0061815234 0061815495 0061816433 0061816434 0061816799 0061817576 0061817981 0061817982 0061817999 0061818000 0061818001 0061818002 0061818003 0061818440 0061818441 0061818710 0061819705 0061819706 0061820091 0061821592 0061821593 0061821980 0061821981 0061821982 0061822587 0061822588 0061822924 0061823031 0061823066 0061824458 0061824886 0061825227 0061825228 0061825484 0061826189 0061826190 0061826492 0061826493 0061826681 0061827327 0061828017 0061828018 0061830095 0061830096 0061830105 0061831681 0061831734 0061831735 0061831736 0061831851 0061831852 0061833558 0061833559 0061834650 0061834651 0061835422 0061835423 0061836366 0061836367 0061837030 0061837031 0061837032 0061837033 0061837034 0061837035 0061837036 0061837037 0061837038 0061837039 0061837204 0061837296 0061837297 0061837895 0061840200 0061841548 0061842989 0061843025 0061843266 0061843596 0061844300 0061845181 0061845292 0061847043 0061847177 0061847178 0061847179 0061847390 0061848009 0061848370 0061848659 0061848660 0061848898 0061849509 0061849510 0061850326 0061850535 0061850537 0061850624 0061850668 0061851936 0061853135 0061853136 0061853137 0061853138 0061853893 0061853894 0061854480 0061854481 0061854482 0061855696 0061855842 0061855843 0061855844 0061856054 0061856055 0061856056 0061856057 0061856058 0061856716 0061856717 0061856718 0061856719 0061856720 0061857399 0061857687 0061857688 0061857725 0061857863 0061858260 0061858276 0061858281 0061858463 0061858693 0061858694 0061858746 0061858747 0061858748 0061858749 0061859368 0061859437 0061859438 0061859439 0061859440 0061859941 0061859942 0061860112 0061860113 0061860115 0061860726 0061861502 0061861505 0061861836 0061861867 0061861989 0061861990 0061862488 0061862489 0061862490 0061863086 0061863087 0061863088 0061863089 0061863784 0061863785 0061863786 0061865296 0061865297 0061865775 0061865848 0061865973 0061865974 0061866001 0061866504 0061867655 0061867656 0061868573 0061868594 0061868742 0061869275 0061869549 0061869550 0061869551 0061869569 0061869670 0061870693 0061870694 0061870696 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0061896875 0061896877 0061896878 0061897235 0061897294 0061897295 0061899651 0061899652 0061901299 0061901300 0061901301 0061901363 00VL853455 00VL853456 00VL853457 Material No. 490103 UDI-DI 04046964302107 Lots 0061814346 0061818627 0061819708 0061822003 0061823034 0061823070 0061826541 0061826687 0061838000 0061840199 0061841084 0061842995 0061843030 0061844305 0061847221 0061853904 0061859985 0061859987 0061864613 0061867900 0061868102 0061873218 0061874587 0061875823 0061877674 0061879968 0061883203 0061885072 0061887373 0061889045 0061891574 0061891616 0061895139 0061895549 00VL860460 00VL860461 00VL860462 00VL861165 00VL861166 00VL861167 00VL861217 00VL861353 Material No. 490104 UDI-DI 04046964186141 Lots 0061822008 0061823080 0061829562 0061837041 0061842985 0061850544 0061862594 0061869523 0061879923 0061891639 0061898725 Material No. 490105 UDI-DI 04046964186165 Lots 0061814347 0061816474 0061818012 0061818013 0061818014 0061821978 0061823074 0061824110 0061824715 0061826543 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Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information ContactBBMI Postmarket Surveillance Department
833-425-1464
Manufacturer Reason
for Recall		In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.
FDA Determined
Cause 2		Process control
ActionOn November 1, 2023, the firm notified customers via URGENT MEDICAL DEVICE CORRECTION letters. Customers were informed that administration sets with lot number 0061902124 and higher were manufactured with revised specifications which should reduce the potential for false air-in-line alarms. After November 30, 2023, all lots distributed by BBMI will have been manufactured with these revised specifications. The firm provided interim measures for users to apply for affected product. For example, users should not use tubing with noticeably smaller outer diameter or which needs to be stretched to fit within the pump. If possible, unaffected lots of product should be diverted to areas that infuse high risk medications or other infusions with acute clinical effects due to initial limited supply of the new administration sets. Affected lots should be diverted to care areas that do not infuse high risk medications or other infusions with acute clinical effects. When infusing high risk medications or infusions with acute clinical effects, customers were advised to have a second pump with an administration set available for exchange in the event of a false alarm. If a second pump is not available, have a second administration set available for exchange in the event of a a false alarm. Additional patient monitoring is required. Adverse reactions or quality problems experienced with this product, or questions about this correction may be reported to BBMI s Postmarket Surveillance Department by calling 1-833-425-1464.
Quantity in Commerce33,820,976 units
DistributionDistribution US nationwide, Canada and Germany.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FPA
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