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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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
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.
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