BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0845-2022 · Initiated November 22, 2021

    Recall

    Recall Number
    Z-0845-2022
    Event Number
    89132
    Firm
    Avanos Medical, Inc.
    FEI Number
    3011270181
    Product Code
    BSY
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    November 22, 2021
    Terminated
    January 31, 2023
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894

    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.

    Action

    The firm sent out a Urgent Advisory Notice dated 11/22/2021 via email to consignees notifying them of recall and identifying affected lots. Consignees were informed to check their unused inventory for affected product, and to subsequently quarantine and destroy any recalled product. Additionally, consignees were provided with a Recall Acknowledgement Form that was to be completed within five business days of receipt and returned to [email protected]. Consignees that have used recalled product and have no additional units in stock are instructed to complete the Recall Acknowledgement Form indicating that they have no inventory of impacted products.

    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)