Type of Product |
Medical Device |
TGA Recall Reference |
RC-2016-RN-00653-1 |
Product Name/Description |
ConMed ThermoGuard Plus ABC Paediatric Dual Dispersive Electrodes
Reference Number: 7-383
Lot Codes: 141010X to 20150705X
ARTG Number: 130647 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
18/05/2016 |
Responsible Entity |
|
Reason/Issue |
The ThermoGard Dual Dispersive Electrode Pads are not compatible with some brands of electrosurgical generators using “passive” CQM (Contact Quality Monitoring) Systems. Whilst there have been no reports of injury or death, there is a possibility of a patient burn when used with a “passive” CQM Electrosurgical Generator. |
Recall Action |
Recall |
Recall Action Instructions |
ConMed Linvatec is advising users to inspect stock and discontinue use of affected devices. Product can be returned to ConMed for credit. This action has been closed-out on 03/02/2017. |
Contact Information |
1800 238 238 - ConMed Australia Customer Service |