BEUDAMED
    FDA Recall Open, Classified

    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A

    Recall: Z-2133-2023 · Initiated May 18, 2023

    Recall

    Recall Number
    Z-2133-2023
    Event Number
    92486
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 18, 2023
    Posted
    July 12, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A

    Reason

    Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".

    Action

    Medline issued a recall notice on 06/02/2023 to its consignees via USPS first class mail. The notice explained the problem with the product and requested the destruction of the product. Medline identified additional products, lots, and consignees and notified their consignees by email on 06/09/2023. Upon receipt of the submitted response form each account will receive over-labels to affix to the affected kits via FedEx overnight, if applicable. distributors were directed to notify their customers and collect the returned product and return it to Medline.

    Distribution

    Worldwide distribution - US Nationwide and the country of Panama.

    Quantity

    144 units