AVNS ambIT System infusion kits recalled for missing air filter
Avanos Medical is recalling certain AVNS ambIT System infusion kits because some units may lack the required air in-line filter. Affected kits were distributed worldwide including the US (Texas and 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 is an FDA Class II recall involving a medical infusion device where some units lack a required air in-line filter component. No hospitalizations, injuries, or deaths have been reported. This constitutes a risk-of-harm product where injury has not yet been reported, scoring 3 (High) per the rubric.
Plain-English summary
Avanos Medical, Inc. is recalling certain AVNS ambIT System - PIB/PCA W 5in Cath kits (Product Code 220507). Some of the recalled kits were potentially distributed without a required air in-line filter.
The recall affects 57 cases containing 285 cassettes. The affected units were distributed worldwide, including the United States (Texas and Oregon) and Australia. The following lot numbers are involved: Lot Number 30177647 (expiration date 17 December 2023) and Lot Number 30174128 (expiration date 14 October 2023).
If you have received this product, check the lot number on the kit packaging. If it matches one of the affected lot numbers listed above, contact Avanos Medical, Inc. or your healthcare provider for instructions on next steps.
The recalled product
- Product
- AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
- Manufacturer
- Avanos Medical, Inc.
- Category
- Medical Device — Infusion System
- Hazard
- missing-filter
- device-defect
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): 30177647 (17 Dec 2023)
- 30174128 (14 Oct 2023)
Distribution
Distributed nationwide across the United States.
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