BEUDAMED
    FDA Enforcement Class II Terminated

    BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use

    Recall: Z-0845-2022 · Reported April 6, 2022

    Enforcement

    Recall Number
    Z-0845-2022
    Event ID
    89132
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Avanos Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 6, 2022
    Initiation Date
    November 22, 2021
    Classification Date
    March 31, 2022
    Termination Date
    January 31, 2023
    Address
    5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-3894, United States

    Description

    BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use

    Reason

    Product was distributed with incorrect expiration date.

    Code Info

    Finished Product Code: 102008602; Alternate Code: 24013-5; Lot No.: 30143745.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.

    Quantity

    20 devices (1 case)