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

BD SmartSite 'Y' Extension Set 2 Needle-Free Valves recalled

Carefusion is recalling BD SmartSite 'Y' Extension Set 2 Needle-Free 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 codesLots: 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

Quantity recalled1,839,594

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-2455-2021
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: Lead & Heavy Metals
Device type: Syringes & Needles

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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

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

Is BD SmartSite 'Y' Extension Set 2 Needle-Free Valves recalled?

Yes. Carefusion recalled BD SmartSite 'Y' Extension Set 2 Needle-Free Valves on 2 Aug 2021. The recall is Class II and its status is Ongoing. Recall number Z-2455-2021.

Why was it recalled?

Which lots are affected?

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

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

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