BEUDAMED
    FDA Enforcement Class II Terminated

    Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - 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-2908-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2908-2020
    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, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - 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: 022019A 052919B 053119A 080819A 022519D 081319E 082619A 082719B 021220E 022820C 060120A 110819A 111919F 030519A 030819A 091019B

    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

    1,058