Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2900-2020 — 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 v

U.S. FDA — Device Enforcement · United States · 2020-07-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2900-2020
Date of alert
2020-07-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Neurovision Medical Products Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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