CAREFUSION: Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

Agency Publication Date: September 13, 2021

Affected Products

Product: BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006

Lots: 20066405 20075901 20075902 20076376 20076377 20116469 21016457 21016458 21016459 21016460 21016690 21016691 21035305 21035306 21035418 21035419 21035420 21035421 21035422 21035423 21035424

Product: BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006

Lots: 20025345 20025483 20037040 20037041 20037042 20086605 20086606 20086696 20095927 20096020 20105323 20125599 20125695 20125709 20125710 21015395

Product: BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006

Lots: 20077170 20077171 20077319 20077320

Product: BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E

UDI: 27613203013813; Lots: 21045673 21045672 21045671 21045670 21045669 21045243 21036889 21036844 21036767 21036766 21036698 21036697 21036696 21036695 21036643 21036642 21026547 21026546 21026545 21026379 21026378 21026377 21026327 21026326 21026325 21026324 21026323 21025283 21025282 21025281 21025280 21025279 21025278 21025157 21025156 21025155 21016751 21016394 21016393 21015306 21015305 20126555 20126554 20126553 20126552 20126529 20126528 20126527 20126526 20125986 20125985 20125984 20125983 20125982 20125981 20125980 20125979 20125978 20125977 20125976 20125975 20125974 20125973 20125972 20125950 20125949 20125948 20115023 20115022 20115021 20115020 20115019 20115018 20115017 20115016 20115015 20115014 20106570 20106231 20106230 20106229 20105085 20105084 20095138 20095137 20095136 20095135 20095134 20095133 20095132 20066719 20066718 20066717 20066448 20066447 20066446 20066231 20066230 20066229 20066228 20066109 20066108 20066107 20066106 20066105 20066104 20055332 20055331 20055330 20055329 20055080 20055079 20055078 20055077 20055076 20045843 20045842 20045841 20045840 20045839 20045838 20045837 20045836 20035578 20035577 20035496 20035495 20035494 20035493 20025024 20025023 20025022 20025021 20016446 20016445 20016444 20016443 20016442 20016317 20016316 20016315 20016194 20016193 20016192 20016191 20016190 20016105 20016104

Product: BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D

Lots: 20015114 20015115 20015116 20015117 20015118 20025813 20025814 20025815 20025816 20025817 20025818 20025819 20036187 20036188 20036259 20036260 20036261 20036262 20036327 20036328 20036329 20037133 20046569 20046570 20046615 20046616 20046617 20055967 20055968 20055984 20055985 20055986 20055987 20055988 20055989 20056364 20056365 20056366 20056452 20056453 20056565 20056566 20057064 20075232 20075235 20075616 20075617 20075238 20085525 20085526 20085774 20085775 20086097 20086098 20086099 20086100 20086101 20086102 20086427 20086428 20086429 20095126 20095127 20095128 20095129 20095130 20095131 20095146 20097042 20095147 20095148 20095150 20095151 20096880 20096881 20097041 20097043 20097044 20097045 20097046 20097047 20105605 20105606 20105607 20106571 20106572 20106573 20106677 20106678 20115001 20115002 20115003 20115004 20115005 20115006 20115007 20115008 20115009 20115010 20115011 20115012 20116408 20116409 20116410 20116411 20116815 20116961 20116830 20116831 20116832 20117063 20117064 20125036 20125037 20125245 20125246 20125247 20125248 20125249 20125250 20125454 20125455 20125456 20125457 20125518 20125519 20125520 20125589 20125590 20125591 20125628 20125629 20125630 20125631 20125632 20125633 20125634 20125635 20125636 20125637 20125638 21015733 21015734 21015735 21015736 21015876 21015877 21015737 21015878 21015879 21015989 21015990 21015991 21016007 21016025 21016026 21016056 21016057 21016058 21016232 21016391 21016392 21035751 21035752 21035753 21035757 21035758 21035754 21035755 21035756 21035759 21035760 21045887 21045888 21045889 21045890 21045891 21046137 21046139 21046140 21046574 21046581 21046656 21046673 21046672 21046717

Product: BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , REF: 10037032; BD GRAVITY BURETTE SET 60 DROP 2 Smartsite VALVES BALL DRIP CHAMBER \VENTED/NONVENTED, REF: 82104E; BD ADD-ON BURETTE SET Smartsite VALVE, REF: 82113E; BD ADD-ON BURETTE SET Smartsite VALVE VENTED/NONVENTED, REF: 82114E; BD ADD-ON BURETTE SET Smartsite VALVE BALL VALVE DRIP CHAMBER V

Lots: 20065590 20065591 20075066 20105945 20105946 20105947 20106408 21015533 21015552 20106612 20115540 21046676 20096121 20115539 21025938 21025939 21025940 21025941 21035175 21035176 20066404 21035174 20096120 20106171 20106172 20106173 20106174 20106175

Product: BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798703;

Lots: 20026497 20025590 20076421 21015406 21015407

Product: BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E

Lots: 21015553

Product: BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Buerette Set SmartSite Port (Burette) 3 SmartSite Y-Sites, REF: 10821753; BD Alaris Pump Infusion Buerette Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 11607787; BD Alaris Pump Infusion Buerette Set 0.2M

Lots: 20055717 20066810 20066818 20066819 20077318 20077321 20077322 20077522 20077523 20077541 20086584 20106957 20106958 20106959 21025085 21025086 21025220 20025114 20025123 20026226 20026227 20026322 20026323 20026382 20026383 20026510 20056946 20056947 20057055 20057056 20017423 20096285 20096286 20015347 20016918 20016919 20016960 20016961 20017112 20035102 20035133 20035134 20035281 20035295 20035296 20035368 20035526 20035527 20035603 20035604 20056757 20065191 20065192 20065281 20065282 20065298 20065299 20065346 20065347 20065362 20065759 20065944 20065945 20065946 20075258 20075510 20075511 20075512 20075577 20075643 20075644 20075660 20075719 20075720 20075721 20075887 20075888 20075889 20075890 20076104 20076847 20076848 20076872 20076873 20076874 20076965 20076966 20076967 20076968 20076969 20077074 20077075 20085132 20085133 20085134 20085135 20085697 20085698 20085699 20085729 20085730 20085731 20085858 20085859 20085875 20085876 20086019 20086020 20086036 20086037 20086213 20086214 20086227 20086228 20086229 20086338 20086339 20086353 20086354 20086491 20086924 20086960 20086966 20086965 20087333 20087334 20087341 20087412 20096174 20096183 20096260 20096366 20096400 20096401 20097100 20097101 20097102 20097157 20015346 20056758 20056830 20056850 20056851 20066701 20066724 20066775 20066776 20066777 20105671 20105706 20125218 20125219 21025839 21025840 21025841 20017400 20017401 20036962

Product: BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010983; BD Gravity Burette Set 60 DP 4 VersaSafe PORTS 3 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10011087; BD EXTENSION SET SMALLBORE TUBING SmartSite VALVE (DETACHABLE), REF: 10011253; BD EXTENSION SET LOW SORBING TUBING 0.2 MICRON FILTER SmartSite VALVE, REF: 10013902; BD EXTENSION SET 2

Lots: 20035964 21016575 20015157 20025207 20025243 20025244 20025245 20025246 20106552 20115468 20115469 21039510 20015758 20055744 20055745 20075637 20075638 20075639 20075673 20096017 20096018 21016323 20125462 20016553 20056551 20076494 20075342 21026223 20075341 21016571 20015128 20015129 20015130 20015131 20015132 20015133 20015134 20015257 20015258 20015259 20015260 20015261 20015908 20015909 20015910 20015911 20016199 20016200 20016201 20016202 20016545 20016546 20016547 20016548 20016549 20016872 20016873 20016874 20016876 20017016 20017017 20017018 20017019 20017077 20017078 20017079 20017080 20017081 20017082 20017432 20017431 20017445 20017446 20017447 20025394 20025395 20025396 20025397 20025398 20025399 20025400 20025401 20025402 20025403 20025537 20025904 20025905 20025906 20025907 20025908 20026416 20026417 20026422 20026612 20026613 20026614 20026615 20026657 20026658 20026655 20026656 20035497 20035498 20035499 20035584 20035585 20035693 20035694 20035695 20035696 20035831 20035832 20035833 20035954 20035974 20035976 20035977 20035978 20035979 20036241 20045312 20045446 20045447 20045448 20045449 20045714 20045715 20045791 20045792 20045793 20045794 20045795 20045796 20045797 20045798 20046047 20046246 20046320 20046321 20046322 20046323 20046324 20046325 20046371 20046372 20046373 20046374 20046539 20046540 20046618 20046619 20046620 20046621 20046645 20046646 20046647 20046648 20046649 20086573 20085924 20085925 20086110 20086111 20087250 20095322 20095323 20095557 20095558 20105992 20106349 20106350 20106351 20106352 20106353 20106354 20106355 20115584 20115585 20115586 20115587 20115589 20115590 20115591 20115592 20115596 20115597 20115599 20115602 20115603 20115604 20115605 20115710 20116994 20116995 20116996 20116997 20116998 20125044 20125045 20125046 20125251 20125252 20125253 20125254 20125639 20125640 20125641 20125642 20125683 20125684 20125685 21016238 21016239 21016240 21025047 21025048 21025046 21025049 21025158 21025284 21025286 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21016416 21016417 21016418 21016419 21016420 21026521 21026522 21026523 21026565 21026567 21026608 21026609 21026625 21026626 21026627 21026692 21026712 21026713 21035108 21035109 20015291 20015292 20015389 20015293 20015294 20015295 20015296 20015297 20015298 20015299 20015300 20015301 20015302 20015303 20015487 20015488 20015489 20015490 20015491 20015513 20015514 20015515 20015516 20015517 20015518 20015519 20015520 20015521 20015887 20015892 20015894 20016032 20016033 20016034 20016035 20016036 20016101 20016037 20016102 20016103 20017312 20017313 20017314 20017315 20017316 20025821 20025822 20025823 20025824 20025825 20025826 20025827 20025991 20025820 20025773 20025992 20025993 20025994 20025995 20025996 20025997 20025998 20025999 20026001 20035866 20035865 20035867 20035868 20035869 20035870 20035871 20035872 20035973 20045190 20045191 20045192 20045193 20045308 20045309 20045310 20045311 20045439 20045440 20045441 20045442 20045443 20045444 20045702 20045703 20045704 20045705 20045706 20045707 20045708 20045709 20045710 20045711 20046120 20046121 20046240 20046241 20046242 20046243 20046382 20046383 20046384 20046456 20046457 20046458 20046459 20046460 20046662 20046663 20046672 20046682 20046683 20046684 20046685 20046779 20046780 20046781 20046875 20046876 20055136 20055137 20055138 20055139 20055140 20055141 20055143 20055142 20055144 20055145 20055146 20065646 20065647 20065648 20065851 20065852 20065853 20065854 20065855 20065856 20065857 20065858 20065859 20065860 20065861 20065862 20075405 20075406 20075407 20075408 20075472 20075473 20075474 20075475 20075476 20075477 20075478 20075479 20075480 20075784 20075785 20075786 20075787 20075788 20075789 20075850 20075851 20075852 20075919 20075920 20075923 20076066 20075921 20075922 20076062 20076063 20076064 20076065 20076067 20076068 20076069 20076242 20076243 20076244 20076245 20076796 20076572 20076573 20076797 20076798 20076799 20076800 20076801 20076802 20076803 20076903 20095296 20095297 20095996 20095298 20095299 20095997 20095998 20095999 20096000 20096001 20096002 20096003 20096004 20096321 20096322 20096323 20096324 20096325 20096326 20096327 20096328 20096329 20096330 20096331 20096332 20096333 20096334 20096335 20096336 20096337 20096338 20096339 20096340 20096341 20096342 20096343 20096344 20096345 20096346 20096347 20096348 20096349 20096350 20096351 20096352 20096353 20096354 20096355 20096356 20096357 20096358 20096359 20096932 20096933 20096934 20096935 20096936 20096937 20096938 20096939 20096961 20096994 20096995 20097259 20105081 20105082 20105083 20105298 20105299 20105300 20105305 20105306 20105307 20105595 20105596 20105597 20105766 20105767 20105768 20105769 20105770 20105771 20105772 20105773 20105774 20105775 20105882 20105883 20105884 20105885 20105886 20105887 20105888 20105889 20105890 20105891 20105892 20105893 20106333 20106457 20106458 20106459 20106460 20106461 20106462 20106463 20106464 20106465 20115402 20115403 20115404 20115405 20115406 20115417 20115418 20115419 20115420 20115421 20115422 20115423 20115424 20115425 20115426 20115427 20115428 20115429 20115444 20115445 20115446 20115447 20115448 20115449 20115407 20115408 20115409 20115410 20115411 20115412 20115450 20115413 20115414 20115415 20115416 20115800 20115795 20115796 20115797 20115798 20115799 20115801 20116168 20116169 20116170 20116171 20116172 20116173 20116174 20116175 20116523 20116176 20116524 20116525 20116526 20116527 20125584 20125585 20125662 20125663 20125664 20125665 20125765 20125766 20125767 20125768 20125769 20125795 20125796 20125797 20125798 20125799 20125881 20125882 20125883 20125884 20125885 20125922 20125923 20125924 20125925 20125926 20125927 20125928 20125929 20125930 20125931 20125932 20125933 20125934 20126083 20126084 20126085 20126086 20126087 20126088 20126089 20126090 21015165 21015166 21015161 21015162 21015167 21015168 21015169 21015163 21015164 21015265 21015266 21015267 21015268 21015269 21015270 21015457 21015458 21015459 21015460 21015461 21015462 21015463 21015464 21025789 21025790 21025791 21025792 21025793 21025794 21025795 21025797 21025798 21025799 21025800 21025801 21025802 21025803 21025804 21025808 21025805 21025806 21025807 21025809 21025810 21025881 21025882 21025883 21025884 21025885 21025886 21025887 21025888 21025889 21025890 21025891 21025892 21025893 21035761 21035762 21035763 21035764 21035765 21035766 21035767 21035924 21035925 21035926 21035927 21035928 21035929 21035930 21035931 21035932 21035933 21035934 21035935 21035936 21035937 21035938 21035939 21035940 21035941 21035942 21035943 21045112 21045113 21045114 21045115 21045116 21045420 21045419 21045421 21045422 21045423 21045424 21045425 21045426 21045427 21045428 21045429 21045430 21045431 21045432 21045435 21045433 21045434 21045436 21055093 21055094 21055095 21055096 21055097 21055303 21055304 21055305 21055306 21055307 21055308 21055309 21055310 21055311 21055312 21055546 21055665 21055666 20096040 20106553 21039793 21039794 21039795 20015143 20015144 20015145 20015146 20015147 20015148 20015149 20015228 20015229 20015230 20015231 20026814 20026815 20026816 20035236 20035237 20035238 20035912 20035914 20035913 20035915 20035916 20035981 20035982 20035980 20046571 20046572 20046573 20046574 20046622 20057093 20065337 20065339 20065615 20065338 20065616 20065617 20065729 20065730 20067103 20067259 20075461 20075462 20076621 20076812 20076814 20077145 20077146 20077147 20077269 20077270 20086539 20086540 20086541 20086542 20086543 20086931 20086544 20086545 20086546 20095443 20095444 20095445 20095446 20095468 20096014 20096015 20095974 20095975 20095976 20099546 20099547 20099548 20099554 20099563 20099567 20099568 20099570 20099571 20109501 20109502 20109504 20109505 20109580 20109581 20109582 20109583 20109584 20109585 20109586 20109587 20109588 20109589 20109590 20119624 20119633 20119634 20119635 20119625 20119626 20119627 20119628 20119629 20119630 20119631 20119632 21019733 21019734 21019735 21019736 21029625 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20089538 20089548 20089549 20089553 20099512 20109525 20109526 20109527 20109528 20109557 20109558 20109559 20109560 20109561 20109562 20109563 20109564 20109565 20109579 20119557 20119558 20119559 20119560 20119561 20119562 20119614 20119615 20119616 20119617 20119618 20119619 20119636 20119637 20119638 20119639 21039511 21039696 21039699 21039700 21039697 21039698 21039701 21039820 21039817 21039821 21039822 20036006 20065679 20115292 20076719 20076720 20085945 20097234 21016366 21016367 20085617 20035873 20035874 20045033 20095305 20095306 20095840 20106343 20115582

Product: BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E

Lots: 20025450 20025451 20025452 20025531 20025532 20025533 20025534 20026527 20026529 20026532 20026533 20026534 20065580 20065582 20065581 20075239 20075240 20075241 20075242 20075618 20075619 20075447 20075448 20075449 20075450 20075451 20075452 20075453 20075790 20075791 20075924 20075792 20085362 20085363 20085364 20085365 20085421 20085422 20085522 20085523 20095302 20095303 20095310 20095533 20095534 20095311 20095312 20116500 20116501 21016470 21016471 21016593 20035697 20066252 20066399 20076260 20095373 20095887 20105859 20105860 20105861 20106710 21019903 21019904 21019905

Product: BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564

Lots: 20026597 20026598 20096477 20106218 20115237 20126022 20126023

Product: BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522E-07; BD GRAVITY 10 DP V/NV CHECK VALVE 3-WAY STOPCOCK 4 Smartsite VALVES & SmartSite EXT SET, REF: 42407E-05

Lots: 20025968 20026013 20035834 20035835 20026132 20026133 20085151

Product: BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF: 20038E7D; BD SmartSite Extension Set One Needle Free Valve, REF: 20039E7D; BD SmartSite Extension Set 1 Needle-Free Valve, 20049E7D; BD Extension Set 1 Needle-Free Valve, REF: 20059E-0006; BD SmartSite Extension Set 1 Needle-Fre

Lots: 20025240 20025241 20025242 20056225 20056231 20056229 20056230 21025820 21025823 21025824 21025825 21025829 20036690 20036691 20036692 20036694 20036983 20046920 20046921 20046922 20055220 20055221 20055222 20055223 20055379 20055380 20055381 20055382 20055503 20055504 20055505 20055506 20055507 20055508 20055880 20055881 20055882 20055883 20055884 20055885 20055886 20055887 20055888 20055889 20055890 20065100 20065101 20065102 20065104 20065103 20065105 20065106 20065107 20065108 20065109 20065110 20065111 20065986 20065987 20065988 20065989 20066898 20066936 20066937 20066938 20066939 20066940 20067172 20075176 20075177 20075481 20075482 20075623 20075483 20075484 20075624 20075625 20075793 20075794 20076070 20076071 20076486 20076487 20076488 20076489 20076490 20076491 20076576 20076577 20076578 20076686 20076687 20076769 20076770 20076771 20076772 20076773 20076774 20077355 20077356 20077357 20077358 20077359 20077360 20077361 20077362 20077363 20077364 20085089 20085090 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Product: BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006

Lots: 20066502 20066503 20066504 20076251 20076352 20086483 20086484 20086485 20086486 20087129 20087130 20096280 20096281 20096282 20096283 20097163 20105074 20105075 20095374 20095375 20096302 20105754 20105755 20105756 20105757 20105758 20115470 21036462 21036463 21036464 21036465 21036466

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88203

Status: Active

Manufacturer: CAREFUSION

Manufactured In: United States

Units Affected: 15 products (1,463,647; 1,839,594; 77,802; 16,700; 630; 344,300; 20,874,700; 708,910; 29,130; 24,360; 44,120; 56,680; 270; 23,786,178; 295,331)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.