BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2133-2023 · Reported July 19, 2023

    Enforcement

    Recall Number
    Z-2133-2023
    Event ID
    92486
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    July 19, 2023
    Initiation Date
    May 18, 2023
    Classification Date
    July 12, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    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".

    Code Info

    UDI/DI (EA) 10159327251772, UDI/DI (CS) 40195327251773; Lot Numbers: 23DDA761

    Distribution

    Worldwide distribution - US Nationwide and the country of Panama.

    Quantity

    144 units