FDA Medical Device Recalls (openFDA)
Avanos Medical, Inc.: AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
- Recall number
- Z-1684-2023
- Recalling firm
- Avanos Medical, Inc.
- Product
- AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
- Status
- Terminated
- Initiated
- 2023-04-24
- Posted
- 2023-06-06
- Terminated
- 2024-08-02
- Reason
- Some of the ambIT kits were potentially distributed without an air in-line filter.
- Root cause
- Under Investigation by firm
- Action
- Avanos Medical notified customers on 04/24/2023 via email. Customers were instructed to evaluate their inventory of products to determine if any of the impacted product codes were present in their facility. The letter provided information identifying the affected product. It was indicated to segregate and contact Avanos to coordinate return/destruction of impacted product. Additionally, customers were instructed to complete and return the Acknowledgement Form.
- Quantity
- 33 cases (165 cassettes)
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
- Lot, serial or model codes
- Lot Number (Expiration Date): 30181360 (17 Dec 2023), 30177648 (17 Dec 2023)
- 510(k) numbers
- ["K162165"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3011270181
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28