CLASS II Device recall · Reported 14 Jun 2023 · FDA Enforcement Report

SMMT ambIT Reusable Program - Luer Cass, Product recalled

Avanos Medical is recalling SMMT ambIT Reusable Program - Luer Cass, Product, distributed nationwide in the US. The recall was initiated on 24 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number (Expiration Date): 30191805 (17 Jan 2025)

Quantity recalled40 cases (200 cassettes)

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-1687-2023
FDA event ID: 92279
Recalling firm: Avanos Medical, Alpharetta, GA
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2023
FDA classified: 6 Jun 2023
Reported: 14 Jun 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Apr 2023	Recall initiated by company
6 Jun 2023	Classified by FDA	+43 days
14 Jun 2023	Published in enforcement report	+8 days

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

Reason for recall

Some of the ambIT kits were potentially distributed without an air in-line filter.

Product as listed by the FDA

SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.

Nationwide Oregon Texas

Questions about this recall

Is SMMT ambIT Reusable Program - Luer Cass, Product recalled?

Yes. Avanos Medical recalled SMMT ambIT Reusable Program - Luer Cass, Product on 24 Apr 2023. The recall is Class II and its status is Terminated. Recall number Z-1687-2023.

Why was it recalled?

Some of the ambIT kits were potentially distributed without an air in-line filter.

Which lots are affected?

Lot Number (Expiration Date): 30191805 (17 Jan 2025)

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.

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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