BEUDAMED
    FDA Recall Terminated

    Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251

    Recall: Z-1406-2023 · Initiated February 3, 2023

    Recall

    Recall Number
    Z-1406-2023
    Event Number
    91741
    Firm
    Avanos Medical, Inc.
    FEI Number
    3011270181
    Product Code
    KXF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 3, 2023
    Posted
    April 19, 2023
    Terminated
    August 19, 2024
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894

    Description

    Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251

    Reason

    Incorrect expiration date.

    Action

    Avanos issued an Urgent Medical Device Recall notice to its consignees on 02/03/2023 by US mail. The notice explained the issue and requested the following: 1) Use the products prior to their 5-year expiration date; 2) Complete and return the Acknowledgement Form via email; and 3) Circulate the notice to all departments and satellite facilities who may have received the product.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Germany, Netherlands, France, Switzerland, Great Britain, Israel, and India.

    Quantity

    5,475 cases