Reported Sep 2, 2020 · Terminated
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI:…
Neurovision Medical Products Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Neurovision Medical Products Inc · 2443 Portola Rd · Ventura, CA · 93003-7726
Is this the product you have?
- Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm
- REFNVTKIT-C7-5, RxOnly, Sterile
- UDIB006NvtKITc752/$$7062818C -
- Product UsageFor 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
- Lot codes and dates
- Kit Lots
105 of 105 codes
052219E052219D052319A052919C053119C060319A060619A060719C061119A061419A061919A062119A070119C071219B080819B082719E091219A091219B091319A091619C091619D102519A110719E110819B111219A111519A111819B111919E112019B112619C012920A020420D020520B020620A020620D020620G021020E021420A021720D022020C022420E030920C030920D031620A031620B041620B051920C060820E071719A071819D072519A072519C080819C081319A081919A082619E091819B091919A091919F100119A
- Kit Lots
- Amount recalled
- 7,250
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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