Recall Z-2900-2020— Neurovision Medical Products Inc

Name: FDA recall Z-2900-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-21

Class II · Terminated

Class II FDA medical device recall by Neurovision Medical Products Inc, initiated 2020-07-21, terminated 2021-04-30. It names one FDA 510(k) clearance: K110989. Product: 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..

Recalling firm: Neurovision Medical Products Inc
Classification: Class II
Status: Terminated
Initiated: 2020-07-21
Terminated: 2021-04-30
Firm location: Ventura, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K110989 — NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODENeurovision Medical Products, Inc.·cleared 2011-11-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.