BEUDAMED
    FDA Enforcement Class II Terminated

    Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided non-sterile and are reusable. The cord is designed to be used with Gyrus ACMI GOCUS 640, Bovie, and other general purpose monopolar electrosurgical generators and appropriate electrodes and endoscopes.

    Recall: Z-1952-2018 · Reported June 6, 2018

    Enforcement

    Recall Number
    Z-1952-2018
    Event ID
    79762
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gyrus Acmi, Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 6, 2018
    Initiation Date
    April 17, 2018
    Classification Date
    May 29, 2018
    Termination Date
    September 18, 2023
    Address
    136 Turnpike Rd, N/A, Southborough, MA, 01772-2118, United States

    Description

    Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided non-sterile and are reusable. The cord is designed to be used with Gyrus ACMI GOCUS 640, Bovie, and other general purpose monopolar electrosurgical generators and appropriate electrodes and endoscopes.

    Reason

    There is a potential for the cord to spark and cause a fire.

    Code Info

    All lots manufactured before December 7, 2017 UDI (00821925008700)

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Japan, Canada, Mexico, Australia, and EU.

    Quantity

    6447