The Recall Desk
HighFDA (Devices)·Z-1686-2023·Announced 2023-06-14

SMMT ambIT Kit Basic Filter Luer Cass Recalled for Missing In-Line Filter

Avanos Medical recalls SMMT ambIT Kit Basic Filter Luer Cass units that were distributed without the required 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: FDA Class II recall of a medical device distributed with missing critical component. No illnesses or injuries reported, but the missing filter poses a risk of device malfunction.

Plain-English summary

Avanos Medical, Inc. is recalling certain SMMT ambIT Kit Basic Filter Luer Cass units (Product Code: 220537) distributed worldwide. The recall involves 45 cases containing 225 cassettes with confirmed distribution in the United States (Texas and Oregon) and Australia.

Some of the distributed kits lack the air in-line filter component that should be present in each unit.

Affected products bear Lot Numbers 30195563 and 30190578, both with expiration date January 17, 2025.

Affected users should verify that their kits contain the air in-line filter component.

The recalled product

Product
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Filter Cassette
Hazard
  • missing-filter

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 (2)

  • Lot Number (Expiration Date): 30195563 (17 Jan 2025)
  • 30190578 (17 Jan 2025)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category