FDA-Device2024-09-04Class II

Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO

Neurovision Medical Products Inc
Hazard

mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.

Sold states
US Nationwide distribution.
Affected count
5 BOXES (25 single kits)
Manufactured in
353 San Jon Rd, Ventura, CA, United States
Products
Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2719-2024

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