CLASS II ONGOING Device recall · Reported 30 Oct 2024 · FDA Enforcement Report

ENT Res, Non-Sterile W Clamp & Female Luer recalled

Smiths Medical ASD is recalling ENT Res, Non-Sterile W Clamp & Female Luer. The recall was initiated on 26 Jun 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 30610586044186, Lot Numbers: 3997242-ENG, 4040002AB, 4040000AB, 4040001AB, 4040008AB, 4040007AB, 4040009AB, 4146021AB

Quantity recalled120960 units

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-0018-2025
FDA event ID: 95305
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 26 Jun 2024
FDA classified: 18 Oct 2024
Reported: 30 Oct 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

26 Jun 2024	Recall initiated by company
18 Oct 2024	Classified by FDA	+114 days
30 Oct 2024	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

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

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

ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI/DI 30610586044186, Lot Numbers: 3997242-ENG, 4040002AB, 4040000AB, 4040001AB, 4040008AB, 4040007AB, 4040009AB, 4146021AB

Where was it sold?

Worldwide distribution.

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 95305

This product is part of a recall event; the main page for the event is CADD Medication Cassette Reservoir, FS recalled by Smiths Medical ASD.

Reported	Class	Recall	Company	Reason	Where
30 Oct 2024	CLASS II	CADD Medication Cassette Reservoir, FS recalled by Smiths Medical ASD	Smiths Medical ASD	Packaging Defects	MN
30 Oct 2024	CLASS II	CADD Medication Cassette Reservoir recalled by Smiths Medical ASD	Smiths Medical ASD	Packaging Defects	MN
30 Oct 2024	CLASS II	ENT Res Non-Sterile W Clamp, Tubing Flag, & Female Luer recalled	Smiths Medical ASD	Packaging Defects	MN
30 Oct 2024	CLASS II	Cadd Medication Cassette Reservoir, FS, Yellow recalled	Smiths Medical ASD	Packaging Defects	MN
30 Oct 2024	CLASS II	CADD Medication Cassette Reservoir, FS recalled by Smiths Medical ASD	Smiths Medical ASD	Packaging Defects	MN
30 Oct 2024	CLASS II	CADD Medication Cassette Reservoir, FS recalled by Smiths Medical ASD	Smiths Medical ASD	Packaging Defects	MN
30 Oct 2024	CLASS II	CADD Medication Cassette Reservoir recalled by Smiths Medical ASD	Smiths Medical ASD	Packaging Defects	MN
30 Oct 2024	CLASS II	CADD Medication Cassette Reservoir, FS recalled by Smiths Medical ASD	Smiths Medical ASD	Packaging Defects	MN

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14 May 2025Device	CLASS I	Cadd-Solis Hpca Ambulatory Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Device Malfunction	Nationwide

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