CLASS II ONGOING Device recall · Reported 22 Sep 2021 · FDA Enforcement Report

BD Extension Set Smallbore Tubing with 2 SmartSite Valves recalled

Carefusion is recalling BD Extension Set Smallbore Tubing with 2 SmartSite Valves, distributed nationwide in the US. The recall was initiated on 2 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 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

Quantity recalled1,463,647

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2454-2021
FDA event ID: 88203
Recalling firm: Carefusion, San Diego, CA
Classification: Class II
Status: Ongoing
Recall initiated: 2 Aug 2021
FDA classified: 13 Sep 2021
Reported: 22 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Aug 2021	Recall initiated by company
13 Sep 2021	Classified by FDA	+42 days
22 Sep 2021	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

14 other products · FDA event 88203

This product is part of a recall event; the main page for the event is BD Gravity Burette Set 60 Drop 1.2 MF 2 SmartSite Valves recalled.

Reported	Class	Recall	Company	Reason	Where
22 Sep 2021	CLASS II	BD Gravity Burette Set 60 Drop 1.2 MF 2 SmartSite Valves recalled	Carefusion	Other	Nationwide
22 Sep 2021	CLASS II	BD Gravity IV Set 3-port Closed Manifold Back Check Valve recalled	Carefusion	Other	Nationwide
22 Sep 2021	CLASS II	BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented recalled	Carefusion	Other	Nationwide
22 Sep 2021	CLASS II	BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter recalled	Carefusion	Other	Nationwide
22 Sep 2021	CLASS II	BD SmartSite Bag Access Device recalled by Carefusion	Carefusion	Other	Nationwide
22 Sep 2021	CLASS II	BD SmartSite 'Y' Extension Set 2 Needle-Free Valves recalled	Carefusion	Other	Nationwide
22 Sep 2021	CLASS II	BD Burette Gravity Set 60 Drop 2 Smartsite Valves Vented/Nonvented recalled	Carefusion	Other	Nationwide
22 Sep 2021	CLASS II	BD SmartSite recalled by Carefusion	Carefusion	Other	Nationwide
22 Sep 2021	CLASS II	BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon recalled	Carefusion	Other	Nationwide
22 Sep 2021	CLASS II	BD Gravity Burette Set 60 DP 3 SmartSite Valves Ball Valve recalled	Carefusion	Other	Nationwide
22 Sep 2021	CLASS II	BD SmartSite Bag Access Device Needle-Free Valve recalled by Carefusion	Carefusion	Other	Nationwide
22 Sep 2021	CLASS II	BD Alaris Pump Infusion Buerette Set Smallbore Tubing recalled	Carefusion	Other	Nationwide
22 Sep 2021	CLASS II	BD Extension Set Smallbore Tubing SmartSite Valve recalled by Carefusion	Carefusion	Other	Nationwide
22 Sep 2021	CLASS II	BD Add-on Burette Set V/NV Needle-Free Valve recalled by Carefusion	Carefusion	Other	Nationwide

More recalls from Carefusion

All 28

Reported	Class	Recall	Company	Reason	Where
28 Sep 2022Device	CLASS II	BD MaxGuard Extension Set recalled by Carefusion	Carefusion	Packaging Defects	39 states
28 Sep 2022Device	CLASS II	BD MaxGuard Extension Set with 4-way stopcock recalled by Carefusion	Carefusion	Packaging Defects	39 states
28 Sep 2022Device	CLASS II	BD MaxGuard Extension Set with 2 Needleless Y-Site recalled	Carefusion	Packaging Defects	39 states
28 Sep 2022Device	CLASS II	BD MaxGuard Extension Set with 0.2 Micron Filter recalled by Carefusion	Carefusion	Packaging Defects	39 states
28 Sep 2022Device	CLASS II	BD MaxGuard Flow Controller Extension Set with Needleless Y-Site recalled	Carefusion	Packaging Defects	39 states

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All 13,778

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