BEUDAMED
    FDA Enforcement Class II Terminated

    AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

    Recall: Z-1684-2023 · Reported June 14, 2023

    Enforcement

    Recall Number
    Z-1684-2023
    Event ID
    92279
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Avanos Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 14, 2023
    Initiation Date
    April 24, 2023
    Classification Date
    June 6, 2023
    Termination Date
    August 2, 2024
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894, United States

    Description

    AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

    Reason

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

    Code Info

    Lot Number (Expiration Date): 30181360 (17 Dec 2023), 30177648 (17 Dec 2023)

    Distribution

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

    Quantity

    33 cases (165 cassettes)