Reported Sep 2, 2020 · Terminated
Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - Product Usage: For…
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?
Cobra x5 2-Ch EMG ET Tube8.0mm
- REFLTE700DCL-5, Rx Only
- Sterile EO UDIB006LTE700DCL52 -
- 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
022019A052919B053119A080819A022519D081319E082619A082719B021220E022820C060120A110819A111919F030519A030819A091019B
- Kit Lots
- Amount recalled
- 1,058
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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