AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
This recall has been terminated (originally issued June 6, 2023).
- Company
- Avanos Medical, Inc.
- Recall Initiated
- April 24, 2023
- Posted
- June 6, 2023
- Terminated
- August 2, 2024
- Recall Number
- Z-1684-2023
- Quantity
- 33 cases (165 cassettes)
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Some of the ambIT kits were potentially distributed without an air in-line filter.
Distribution
Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Lot / Code Info
Lot Number (Expiration Date): 30181360 (17 Dec 2023), 30177648 (17 Dec 2023)
Root Cause
Under Investigation by firm
Action Taken
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.