BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0306-2025 · Initiated October 3, 2024

    Recall

    Recall Number
    Z-0306-2025
    Event Number
    95509
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    KDD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 3, 2024
    Posted
    November 5, 2024
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    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.

    Action

    DeRoyal issued an URGENT! DEROYAL RECALL NOTICE to its consignees on 10/03/2024 via email. The notice explained the issue, potential risk, and requested the return of the affected packs. If the affected product was further distributed, the notice directed the distributor to notify its customers. This may be achieved directly by forwarding the recall notification and notify DeRoyal that you have done so, or the distributor may provide DeRoyal with your customer listing allowing them to contact your customers.

    Distribution

    US Nationwide distribution in the state of OH.

    Quantity

    780 units