BEUDAMED
    FDA Enforcement Class II Terminated

    SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332

    Recall: Z-1097-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-1097-2020
    Event ID
    84721
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2020
    Initiation Date
    January 13, 2020
    Classification Date
    February 6, 2020
    Termination Date
    August 10, 2021
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332

    Reason

    Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.

    Code Info

    1921032

    Distribution

    Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.

    Quantity

    15150