BEUDAMED
    FDA Enforcement Class II Ongoing

    DeRoyal C-SECTION TRACEPACK, REF 89-9338-06

    Recall: Z-0306-2025 · Reported November 13, 2024

    Enforcement

    Recall Number
    Z-0306-2025
    Event ID
    95509
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 13, 2024
    Initiation Date
    October 3, 2024
    Classification Date
    November 5, 2024
    Address
    200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States

    Description

    DeRoyal C-SECTION TRACEPACK, REF 89-9338-06

    Reason

    DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.

    Code Info

    UDI/ DI 00749756927864 (each), 50749756927869 (case): Lot Numbers: 59098305, exp 4/1/2027; 59161271, exp 3/1/2025; 59245221, exp 6/1/2025; 59287659, exp 5/1/2025; 59716337, exp 5/1/2025;59866546, exp 12/1/2025; 59962811, exp 11/1/2025; 59996754, exp 12/1/2025; 60104426, exp 11/1/2025

    Distribution

    US Nationwide distribution in the state of OH.

    Quantity

    780 units