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