Lower risk Medical device recall · FDA · Published August 2, 2021

CAREFUSION Gravity Burette Sets: Flow Issues May Cause Therapy Delays

CAREFUSION recalls Gravity Burette Sets with potential flow problems that could delay medical therapy. Affected models include 60-drop sets with specific serial numbers. Contact CAREFUSION for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2456-2021Medical device CAREFUSION ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmCAREFUSION10020 Pacific Mesa Blvd · San Diego, CA 92121-4386

✎ GovInfoNow plain-language explainer

CAREFUSION is recalling Gravity Burette Sets that may have flow issues, causing therapy delays. This affects medical devices used for treatments requiring precise fluid delivery. Read more at govinfonow.com/recall/62091-carefusion-gravity-burette-sets-flow-issues-may-cause-therapy-delays.

Source Summary by GovInfoNow · govinfonow.com/recall/62091-carefusion-gravity-burette-sets-flow-issues-may-cause-therapy-delays · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2456-2021

Cite this page

“CAREFUSION Gravity Burette Sets: Flow Issues May Cause Therapy Delays.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62091-carefusion-gravity-burette-sets-flow-issues-may-cause-therapy-delays. Based on FDA recall #Z-2456-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2456-2021%22&limit=1).

The FDA announced on August 2, 2021, that CAREFUSION is recalling BD Gravity Burette Sets due to potential valve issues that could cause therapy delays. The agency issued recall number Z-2456-2021 for the Class II device.

How to tell if you have it

Brand: CAREFUSION
Product: BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031
Product: BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037032
Product: BD GRAVITY BURETTE SET 60 DROP 2 Smartsite VALVES BALL DRIP CHAMBER \VENTED/NONVENTED, REF: 82104E
Product: BD ADD-ON BURETTE SET Smartsite VALVE, REF: 82113E
Product: BD ADD-ON BURETTE SET Smartsite VALVE VENTED/NONVENTED, REF: 82114E
Product: BD ADD-ON BURETTE SET Smartsite VALVE BALL VALVE DRIP CHAMBER VENTED/NONVENTED, REF: 82115E
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
Units affected: 77,802

The hazard

According to the FDA, needle-free connector valves in these products may have issues including difficulty to flush, flow issues, and partial or total occlusions. These defects could lead to therapy delay.

Context

GovInfoNow's records show CAREFUSION has two other recalls on record since June 9, 2021. On August 1, 2022, the company recalled BD MaxGuard Extension Sets due to expiration year mismatch risks. On June 9, 2021, CAREFUSION recalled MaxPlus bi fuse extension sets due to leakage risk in needleless connectors. Other recent recalls of similar products include B Braun Medical IV Set Recall: Backflow Risk in Gravity Pumps (October 29, 2025) and B Braun Medical IV Sets Recall: Backflow Risk in Gravity IV Systems (October 29, 2025).

How to tell if you have this one

Check for model numbers like 'BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES' with serial numbers listed in the recall notice. These sets were sold between 2006 and 2011.

Brand
CAREFUSION
Category
Medical device

FDA recall event · 15 products

All 15 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, PA, NC, OH, SC, IL, RI, MO, NY, TN, AL, VA, PR, CA, NE, NJ, MI, MD, NM, LA, KY, NV, ME, OK, WA, MA, WV, TX, AR, OR, KS, GA, VT, IN, WY, AZ, CO, MN, WI, UT, SD, MS, ID, MT, ND, HI, IA, DC, AK, NH, CT, DE, GU and the countries of CA, NZ, TW, AU, BE, VN, AR, MY, TH, KR, ID, PH, SG, BH, SA, HK, IN, CN, BR.

Recall number	Product, codes & lots	Quantity
Z-2454-2021	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	1,463,647
Z-2455-2021	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	1,839,594
Z-2456-2021	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 VENTED/NONVENTED, REF: 82115E; 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	77,802
Z-2457-2021	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	16,700
Z-2458-2021	BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E; Lots: 21015553	630
Z-2459-2021	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 0.2Micron Filter Ball Valve SmartSite Port (Burette) 2 SmartSite Y-Sites, REF: 11613191; BD Alaris Pump Infusion Buerette Set Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2440-0600; BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Site, REF: 2441-0007; BD Alaris Pump Infusion Buerette Set Low Sorbing Tubing Smartsite Port (Burette), REF: 2444-0007; BD Alaris Pump Infusion Buerette Set Ball Valve Smartsite Port (Burette) 2 Smartsite Y-Sites, REF: 2447-0007; BD Alaris Pump Infusion Set Back Check Valve 4-Way Stopcock 3 Smartsite Y-Sites Extension Set With SmartSite Port, REF: C24104E; 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	344,300
Z-2460-2021	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 SmartSite VALVES Y-CONNECTOR, REF: 10014692; BD EXTENSION SET SMALLBORE TUBING 2 DETACHABLE SmartSite VALVES, REF: 10015488; BD SmartSite NEEDLE FREE VALVE, REF: 2000E; BD Extension Set J-LOOP SMALLBORE Tubing SmartSite VALVE, REF: 20021E; BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 20035E; BD Extension Set SMALLBORE Tubing SmartSite VALVE SLIP LUER, REF: 20037E; BD Extension Set TRI-PORT SMALLBORE Tubing 3 SmartSite VALVES, REF: 20038E; BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 20039E; BD Extension Set SmartSite VALVE SLIP LUER, REF: 20057E; BD Extension Set SmartSite VALVE, REF: 20059E; BD extension Set Y-CONNECTOR 2 SmartSite VALVES, REF: 20061E; BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite VALVES, REF: 20062E; BD EXTENSION SET Y-CONNECTOR 2 SmartSite VALVE, REF: 20159E; BD Extension Set TRI-PORT SMALLBORE TUBING SmartSite VALVE DETACHABLE, REF: 20338E; BD EXTENSION SET SmartSite VALVE, REF: 21059E; BD 8.5-IN PRESSURE RATED EXTENSION SET SmartSite VALVE, REF: 22003E-07; BD Texium SmartSite VALVE MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T; BD EXTENSION SET SmartSite VALVE (DETACHABLE), REF: 22059E; BD EXTENSION SET SmartSite VALVE (DETACHABLE) SLIP LUER, REF: C25015E; BD SmartSite Syringe-Syringe Transfer Device, REF: MV0450; 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 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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 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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 21029626 21029688 21029627 21029689 21029690 21029691 21029692 21029693 21029628 21029629 21029630 21029631 21029632 21029633 21029634 21029635 21029636 21029637 21029638 21029720 21029721 21029722 21029723 21029724 21029725 21029639 21049630 21049631 21049632 21049633 21049635 21059503 21059512 21059612 21059881 20096296 20106551 20017023 20096038 20115375 20115376 20016205 20027096 20056457 20075676 20085789 20096455 20096547 20105632 20105633 20106516 20116316 20116317 21016579 21039822 21039823 21049654 21059507 21059516 21059746 20095143 20095144 20097132 20097133 20097134 20016655 20016656 20016657 20017033 20017034 20017035 20017036 20017093 20017094 20017095 20027009 20027010 20027011 20027012 20027013 20027014 20027136 20027137 20027138 20027139 20035233 20035235 20035271 20035272 20035273 20036333 20036334 20036335 20036374 20036375 20036376 20036638 20036639 20036640 20036641 20037265 20037378 20037379 20037380 20037381 20069048 20069049 20069050 20079754 20079755 20089527 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	20,874,700
Z-2461-2021	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	708,910
Z-2462-2021	BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564; Lots: 20026597 20026598 20096477 20106218 20115237 20126022 20126023	29,130
Z-2463-2021	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	24,360
Z-2464-2021	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	44,120
Z-2465-2021	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	56,680
Z-2466-2021	BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006; Lots: 20077170 20077171 20077319 20077320	270
Z-2467-2021	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-Free Valve, REF: 20060E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20061E7D; BD SmartSite Extension Set Check Valve 3 Needle Free Valves, REF: 20062E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20159E7D; BD Alaris GP Series SmartSite Burette Set, REF: 60103E; BD Alaris GP Series Burette Set No Filter, REF: 63441E; Alaris SmartSite needle-free valve, REF: 2000E7D; 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 20085091 20085092 20085289 20085290 20085291 20085366 20087446 20087447 20087448 20095317 20095318 20105086 20105087 20105088 20105089 20105571 20105572 20105993 20106356 20106357 20106358 20106359 20106360 20106361 20106362 20106363 20106364 20106402 20106403 20106404 20106405 20106406 20106407 20106727 20115182 20115183 20115184 20115186 20115205 20115207 20115208 20115181 20115533 20115203 20115534 20116576 20116577 20116578 20116579 20116580 20116581 20116582 20116583 20116584 20116585 20116586 20116587 20116588 20116589 20116590 20116591 20116592 20116593 20116594 20116595 20126194 20126195 20126196 20126197 20126198 20126249 20126250 20126251 20126252 20126253 20126254 20126255 21015660 21015661 21015724 21015725 21015753 21015754 21015775 21015776 21015777 21015778 21015897 21015898 21015899 21015900 21015901 21016150 21016151 21015902 21016152 21015896 21035775 21035776 21035777 21035778 21035779 21035780 21035781 21035782 21036838 21036839 21036840 21036841 21036842 21036874 21045277 21045278 21045279 21045280 21045281 21045282 21045284 21045285 20026035 20026036 20056669 20056670 20056671 20066232 20066233 20066234 20066235 20115387 20115388 20115389 20115390 20115391 20125048 20125334 20125313 20125314 21015747 21015748 21015933 21015934 21045416 21045415 21045417 20026037 20026038 20026039 20045035 20097181 20097182 20115384 20115385 20115386 20125332 20125333 20126421 20017143 20017144 20035163 20035164 20035255 20035256 20035452 20035453 20035454 20077208 20077209 20077210 20077211 20077248 20085800 20085801 20085802 20085803 20085804 20085805 20085806 20086310 20086311 20086312 20086313 20086314 20086315 20095355 20106470 20106471 20106472 20106473 20106474 20115306 20115307 20115308 20115309 20115310 20116459 20116460 20116506 20116842 20116843 20116959 20116960 20117003 20117004 20117005 20126275 20126276 20126277 20126278 21026315 21026316 21036130 21036131 21036132 21036133 21036134 21036135 21036136 20016252 20016253 20016254 20016255 20016256 20016257 20016258 20016259 20016260 20016261 20016540 20016541 20016542 20016543 20016544 20016689 20016690 20016691 20016692 20016693 20017011 20017012 20017013 20017014 20017015 20017073 20017074 20017075 20017076 20027157 20027158 20027159 20027160 20035250 20035251 20035685 20035686 20035687 20036089 20036090 20036091 20036092 20036184 20036185 20036186 20036434 20036458 20036459 20036460 20036461 20036462 20036463 20036464 20056672 20056698 20056699 20056700 20056701 20056702 20066601 20066602 20066603 20066604 20066605 20067001 20067002 20067003 20067004 20067005 20067006 20067007 20067008 20067218 20067219 20067220 20067221 20067222 20067223 20067224 20067225 20067226 20067227 20075225 20075226 20075228 20075229 20085419 20085420 20085510 20085511 20085512 20085768 20085769 20085829 20085830 20085831 20085832 20085833 20085834 20085835 20106574 20106575 20106576 20106577 20106578 20106579 20115320 20115321 20115322 20115351 20115323 20115324 20115329 20115335 20115336 20115345 20115346 20115330 20115331 20115332 20115333 20115337 20115338 20115339 20115325 20115326 20115327 20115334 20115340 20116509 20116510 20116511 20125315 20125316 20125458 20125459 20125460 20125461 20125523 20125524 20125525 20125582 20125583 21016029 21016030 21016031 21016032 21016033 21016034 21016035 21016036 21016037 21016038 21016233 21016234 21016235 21016236 21016310 21016311 21016312 21016313 21016314 21016315 21016316 21016317 21016428 21016429 21016430 21016431 21016432 21016598 21016599 21016600 21016601 21016656 21016657 21016658 21025037 21025038 21025039 21025040 21025041 21025042 21025043 21025512 21025513 21025514 21025515 21025516 21025517 21025518 21025519 21025520 21025521 21025522 21025523 21025524 21025525 21025747 21025748 21025749 21025750 21025751 21025752 21025753 21025754 21025755 21025756 21025757 21025758 21026234 21026235 21025759 21026189 21026190 21026191 21026192 21026236 21026237 21026238 21026239 21026240 21026241 21026242 21026243 21026244 21035339 21035350 21035351 21035352 21035355 21035356 21035353 21035354 21035357 21035358 21035359 21035361 21035362 21035438 21035439 21035440 21035441 21035442 21035443 21035444 21035445 21035446 21035649 21035650 21035651 21035360 21035652 21035653 21035654 21035655 21035656 21045121 21045122 21045124 21045123 21045583 21045584 21045586 21045589 21045590 21045587 21045591 20026042 20056373 20076073 20016653 20016654 20056799 20086132 20106389 20106390 20106409 20116233 20116234 21036467 21036468 21046006 20115803 20125787 21016498 21035172 20116554 20116555 20125592 20125593 21036533 21036534 21036535 21046525 21046550 21046595 21046596 21046633 20105459 20107206 21015001 20026728 20026729 20026730 20026852 20026853 20026865 20026866 20026882 20026883 20037109 20037110 20037111 20066210 20066351 20066482 20066549 20066582 20076167 20076187 20076306 20076307 20076319 20076320 20076321 20076322 20076400 20076401 20076507 20076508 20105324 20105670 20116236 20116237 20116238 20116270 20116271 20116369 20117006 20117007 20117008 20125276 20125277 20125465 20125466 20125489 20125490 20125547 20125598 21015686 21035102 21035103 21035268 21035269 21035290 21035387 21035388 21035522 21035607 21035608 21035701 21046420 21046421 21046453 21046454 21046455 20076662 20096261 21046587 1021008 1021015 1020967 1020131 1019886 1019892 1019925 1019583 1019582 1019584 1019392 1018579 1018578 1018584 1019393 1018583 1018316 1018577 1018576 1018575 1018317 1018010 1017964 1017679 1017680 1017681 1017154 1017306 1017152 1017045 1017153 1016762 1016663 1016664 1016761 1015511 1016651	23,786,178
Z-2468-2021	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	295,331

Based on the official FDA remedy

What to do — step by step

Check Product Model
Look for model numbers such as 'BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES' or similar variants with the listed serial numbers.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of FL, PA, NC, OH, SC, IL, RI, MO, NY, TN, AL, VA, PR, CA, NE, NJ, MI, MD, NM, LA, KY, NV, ME, OK, WA, MA, WV, TX, AR, OR, KS, GA, VT, IN, WY, AZ, CO, MN, WI, UT, SD, MS,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 51 days after the firm started it.

Aug 2, 2021Firm started the recall
Sep 13, 2021FDA classified it Class II
Sep 22, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these sets immediately?

No, the recall does not require immediate stoppage. The product can be used safely if properly connected and no issues are detected.

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Link to this recall

<a href="https://govinfonow.com/recall/62091-carefusion-gravity-burette-sets-flow-issues-may-cause-therapy-delays">CAREFUSION Gravity Burette Sets: Flow Issues May Cause Therapy Delays (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2456-2021 (August 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2456-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.