BEUDAMED
    FDA Recall Terminated

    Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

    Recall: Z-0781-2021 · Initiated November 13, 2020

    Recall

    Recall Number
    Z-0781-2021
    Event Number
    86826
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    OGR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 13, 2020
    Terminated
    October 26, 2021
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

    Reason

    The cylindrical sponge component is not x-ray detectable.

    Action

    Customers were notified by email on 11/13/2020. Customers are asked to return the response form via fax or email. The recalling firm will send subsequent letters to consignees that have not provided a response to the recall notification within the allotted time. No product is to be returned to Medline Industries. Consignees are instructed to apply labels to their affected kits and return to inventory. The label indicates that there is a recalled component within the pack, not to use it, and replace from a different sterile supply. No other components within the kit are affected.

    Distribution

    Foreign distribution only - Canada.

    Quantity

    40