The Recall Desk
HighFDA (Devices)·Z-1688-2023·Announced 2023-06-14

Avanos Recalls ambIT Cassette Filters for Missing Air In-Line Filter

Avanos Medical is recalling ambIT Cassette Filter Male Luer (Product Code 220266) because some units were potentially distributed without an air in-line filter component.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall for units distributed without an air in-line filter component. No illnesses or injuries have been reported, constituting a risk-of-harm situation where potential injury has not yet occurred.

Plain-English summary

Avanos Medical, Inc. is recalling the ambIT Cassette Filter Male Luer, Product Code 220266. Some kits were potentially distributed without an air in-line filter component.

The affected product was distributed worldwide, including in the United States (Texas and Oregon) and Australia. The affected lot is F201701, expiring January 17, 2025. A total of 1,155 units were potentially affected, including 280 individually packaged units.

Healthcare providers and facilities that received affected units should verify the presence of the air in-line filter component before use. Units missing the air in-line filter should not be used. Affected customers should contact Avanos Medical, Inc. for replacement units or further guidance.

This is a Class II medical device recall issued by the U.S. Food and Drug Administration under recall number Z-1688-2023.

The recalled product

Product
ambIT Cassette Filter Male Luer, Product Code: 220266
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Filtration / Respiratory
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number (Expiration Date): F201701 (17 Jan 2025)

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Avanos Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Avanos Medical, Inc.

See all →