BEUDAMED
    FDA Enforcement Class II Terminated

    Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.

    Recall: Z-2907-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2907-2020
    Event ID
    86102
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Neurovision Medical Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2020
    Initiation Date
    July 21, 2020
    Classification Date
    August 27, 2020
    Termination Date
    April 30, 2021
    Address
    2443 Portola Rd, N/A, Ventura, CA, 93003-7726, United States

    Description

    Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.

    Reason

    The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.

    Code Info

    Kit Lots: 021919D 022019B 040119C 040319C 040419A 071019A 010820C 020520C 021020I 021220A 061220A 061720C 120419E 120919B 042319A 072419B 091019A 091619A 091719C 092019A 092419A 050219B 051419B 052819A 060519B 070519A 022019B 022619C 061319B 061419B 072619B 061820C 080919A 081419C 082219A 082619C 052120A 110719A 111919A 121319A 022020B 022420A 031720C 062420C 041020A

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, MI, MN, MO, MS, NE, NY, OH, OR, PA, SC, SD, TN, TX, WA, WI and the countries of Canada, Dominican Republic, Hong Kong.

    Quantity

    3,425