BEUDAMED
    FDA Enforcement Class II Terminated

    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - 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-2902-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2902-2020
    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, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - 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: 012320C 012720C 012820B 012920C 013020C 020720D 021020D 021320E 021420B 021420D 021820B 031220A 031620C 041620A 052120C 060820F 061120B 111319C 120219G 120619A 121819B 121919F 122319B 122719A 123019A 072919B 073019A 073119B 010820E 090419A 112619A 101019B 102319B 102819A 102919A 103019A 103119A 111219F 112619G 112719C 120219F 060420A 062920A

    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

    1,239