BEUDAMED
    FDA Recall Terminated

    Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

    Recall: Z-1357-2020 · Initiated January 21, 2020

    Recall

    Recall Number
    Z-1357-2020
    Event Number
    84908
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    OJH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 21, 2020
    Posted
    February 11, 2020
    Terminated
    January 12, 2023
    Address
    Three Lakes Drive, Northfield, IL, 60093

    Description

    Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

    Reason

    The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.

    Action

    Consignees were notified by telephone on 01/21/2020 followed by an e-mail on 01/22/2020 and 02/05/2020 that included a formal recall letter with response form. The recall letter identified the affected product and requested the user to quarantine the product for subsequent pick up by Medline Industries Inc. Consignee was asked to complete and return Recall Response form.

    Distribution

    California only. No governmental, Canadian or Mexican consignees. TORRANCE MEMORIAL MEDICAL 3105 LOMITA BLVD TORRANCE CA 905055108 HOAG MEMORIAL HOSPITAL 1 HOAG DR NEWPORT BEACH CA 926634162 OWENS/MINORVMI TEM (65) 5125 ONTARIO MILLS PKWY ONTARIO CA 917645103

    Quantity

    122