The Recall Desk
HighFDA (Devices)·Z-1687-2023·Announced 2023-06-14

Avanos Medical Recalls ambIT Reusable Cassettes Missing Air-Inline Filter

Avanos Medical is recalling SMMT ambIT Reusable cassettes (Product Code 220568, Lot 30191805) that were potentially distributed without a required air-in-line filter. The missing component affects units in Texas, Oregon, and Australia.

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 FDA Class II recall involves a missing critical safety component (air-in-line filter) on medical cassettes. While the missing filter represents a structural defect that could pose a safety risk, no illnesses or injuries have been reported, placing it in the 'High' category rather than 'Severe.'

Plain-English summary

Avanos Medical, Inc. is recalling certain SMMT ambIT Reusable Program cassettes (Product Code 220568, Lot 30191805). Some of the cassettes were potentially distributed without an air-in-line filter, which is a required safety component of the system.

The affected recall involves 40 cases containing a total of 200 cassettes. These units were distributed to customers in Texas, Oregon, and Australia. The lot expires January 17, 2025.

The missing air-in-line filter is the basis for this FDA Class II recall. Customers who may have received affected cassettes should contact Avanos Medical, Inc. to verify whether their units are part of this recall.

The recalled product

Product
SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Infusion Cassette System
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): 30191805 (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.

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Same hazard · missing filter

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