BEUDAMED
    FDA Recall Terminated

    AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

    Recall: Z-1685-2023 · Initiated April 24, 2023

    Recall

    Recall Number
    Z-1685-2023
    Event Number
    92279
    Firm
    Avanos Medical, Inc.
    FEI Number
    3011270181
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 24, 2023
    Posted
    June 6, 2023
    Terminated
    August 2, 2024
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894

    Description

    AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

    Reason

    Some of the ambIT kits were potentially distributed without an air in-line filter.

    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.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.

    Quantity

    57 cases (285 cassettes)