BEUDAMED
    FDA Enforcement Class II Terminated

    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - 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-2900-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2900-2020
    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

    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - 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 070919A 072619A, 073119A 082019B, 120219D 120319G 120519A 121819E 121919E 122019B 010820D 011520A 011620A 012320D 012420B 030620A 031220E 052120B 062620A 022820A 041620C 062520A

    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

    1,089