CLASS II ONGOING Device recall · Reported 28 Sep 2022 · FDA Enforcement Report

BD MaxGuard Extension Set with 4-way stopcock recalled by Carefusion

Carefusion is recalling BD MaxGuard Extension Set with 4-way stopcock, distributed in 39 states. The recall was initiated on 1 Aug 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 10885403235788, Lots: 22019324, 22019323, 22019322

Quantity recalled46,900

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-1752-2022
FDA event ID: 90707
Recalling firm: Carefusion, San Diego, CA
Classification: Class II
Status: Ongoing
Recall initiated: 1 Aug 2022
FDA classified: 16 Sep 2022
Reported: 28 Sep 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

1 Aug 2022	Recall initiated by company
16 Sep 2022	Classified by FDA	+46 days
28 Sep 2022	Published in enforcement report	+12 days

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

Reason for recall

Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

BD MaxGuard Extension Set with 4-way stopcock, REF: M4058

Where it was distributed

US: TN, FL, LA, VA, MI, OH, NC, WA, UT, TX, NV, AL, AR, IA, MA, CO, NY, SC, IN, KY, MO, MD, PA, CA, IL, SD, GA, MS, AZ, WV, ID, WY, VT, NM, OR, NJ, OK, KS, MN

Alabama Arkansas Arizona California Colorado Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 10885403235788, Lots: 22019324, 22019323, 22019322

Where was it sold?

US: TN, FL, LA, VA, MI, OH, NC, WA, UT, TX, NV, AL, AR, IA, MA, CO, NY, SC, IN, KY, MO, MD, PA, CA, IL, SD, GA, MS, AZ, WV, ID, WY, VT, NM, OR, NJ, OK, KS, MN

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

8 other products · FDA event 90707

This product is part of a recall event; the main page for the event is BD MaxGuard Drop Administration set recalled by Carefusion.

Reported	Class	Recall	Company	Reason	Where
28 Sep 2022	CLASS II	BD MaxGuard Drop Administration set recalled by Carefusion	Carefusion	Packaging Defects	39 states
28 Sep 2022	CLASS II	BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites recalled	Carefusion	Packaging Defects	39 states
28 Sep 2022	CLASS II	BD MaxGuard Extension Set with 1.2 Micron Filter recalled by Carefusion	Carefusion	Packaging Defects	39 states
28 Sep 2022	CLASS II	BD MaxGuard Flow Controller Extension Set with Needleless Y-Site recalled	Carefusion	Packaging Defects	39 states
28 Sep 2022	CLASS II	BD MaxGuard Flow Controller Extension Set with Needleless Y-Site recalled	Carefusion	Packaging Defects	39 states
28 Sep 2022	CLASS II	BD MaxGuard Extension Set with 0.2 Micron Filter recalled by Carefusion	Carefusion	Packaging Defects	39 states
28 Sep 2022	CLASS II	BD MaxGuard Extension Set with 2 Needleless Y-Site recalled	Carefusion	Packaging Defects	39 states
28 Sep 2022	CLASS II	BD MaxGuard Extension Set recalled by Carefusion	Carefusion	Packaging Defects	39 states

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 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
28 Sep 2022Device	CLASS II	BD MaxGuard Flow Controller Extension Set with Needleless Y-Site recalled	Carefusion	Packaging Defects	39 states

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide