AVNS ambIT Catheter System Kits Recalled for Missing Air Filter
Avanos Medical recalls some AVNS ambIT System catheter kits that were potentially distributed without an air in-line filter. Affected units were distributed worldwide, including 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: FDA Class II medical device recall with a missing component creating potential risk, but no illnesses, injuries, or deaths reported. The hazard is theoretical without documented adverse events, placing it at the High severity threshold.
Plain-English summary
Avanos Medical, Inc. is recalling certain AVNS ambIT System kits (Product Code 220509) that were potentially distributed without an air in-line filter. A total of 33 cases containing 165 cassettes are affected.
The missing air-in-line filter represents a device defect that creates a potential safety hazard. No illnesses or injuries have been reported in association with this recall.
Affected lot numbers are 30181360 and 30177648, both with expiration dates of December 17, 2023. The recalled units were distributed worldwide, with confirmed distribution in Texas, Oregon, and Australia.
Healthcare facilities and patients who have received these kits should discontinue use and contact Avanos Medical for replacement or guidance. Refer to FDA recall notice Z-1684-2023 for additional details and instructions.
The recalled product
- Product
- AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
- Manufacturer
- Avanos Medical, Inc.
- 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): 30181360 (17 Dec 2023)
- 30177648 (17 Dec 2023)
Distribution
Distributed nationwide across the United States.
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