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

BD Alaris Pump Infusion Buerette Set Smallbore Tubing recalled

Carefusion is recalling BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3, 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: 20077170 20077171 20077319 20077320

Quantity recalled270

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-2466-2021
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 Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006

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?

Lots: 20077170 20077171 20077319 20077320

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 Extension Set Smallbore Tubing with 2 SmartSite Valves 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 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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