BEUDAMED
    FDA Enforcement Class II Terminated

    Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

    Recall: Z-1807-2020 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1807-2020
    Event ID
    85402
    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
    May 6, 2020
    Initiation Date
    March 26, 2020
    Classification Date
    April 28, 2020
    Termination Date
    July 15, 2020
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

    Reason

    Due to a distribution error, product from the affected lot was shipped expired.

    Code Info

    Lot 16240231, GTIN 07613327297799

    Distribution

    International distribution the country of Canada.

    Quantity

    40 units