Health product recall

Nerveana CN X/RLN Monitoring Kit With 1-Channel Cobra EMG ET Tube, Cobra 1 & 2-Channel EMG ET Tube And 2 Subdermal Needles (2020-07-22)

Starting date:
July 22, 2020
Posting date:
August 14, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73707

Last updated: 2020-08-14

Affected Products

  1. Nerveana CN X/RLN Monitoring Kit With 1-Channel Cobra EMG ET Tube
  2. Cobra 2-Channel EMG ET Tube And 2 Subdermal Needles
  3. Cobra 1-Channel EMG ET Tube And 2 Subdermal Needles

Reason

The electrode insulation material has potential to degrade sooner than established shelf life. This could make the electrode more susceptible to damage by dental scratching or acute bending. This may interfere with EMG performance.

Affected products

A. Nerveana CN X/RLN Monitoring Kit With 1-Channel Cobra EMG ET Tube
Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • NVTKIT-C6-5
  • NVTKIT-C7-5
  • NVTKIT-C8-5
Companies
Manufacturer
Neurovision Medical Products, Inc.
353 Sanjon Road
Ventura
93001
California
UNITED STATES

B. Cobra 2-Channel EMG ET Tube And 2 Subdermal Needles
Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • LTE700DCL-5
  • LTE700DCM-5
  • LTE700DCS-5
Companies
Manufacturer
Neurovision Medical Products, Inc.
353 Sanjon Road
Ventura
93001
California
UNITED STATES

C. Cobra 1-Channel EMG ET Tube And 2 Subdermal Needles
Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • LTE700L-5
  • LTE700M-5
  • LTE700S-5
Companies
Manufacturer
Neurovision Medical Products, Inc.
353 Sanjon Road
Ventura
93001
California
UNITED STATES