BEUDAMED
    FDA Enforcement Class II Ongoing

    Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219

    Recall: Z-2089-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2089-2023
    Event ID
    92445
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 12, 2023
    Initiation Date
    May 30, 2023
    Classification Date
    July 3, 2023
    Address
    200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States

    Description

    Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219

    Reason

    The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

    Code Info

    a) REF 89-6219, GTIN 50749756664382 (cs), 00749756664387 (unit), Lot Numbers: 58807114

    Distribution

    US Nationwide distribution.

    Quantity

    3 packs