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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 ConMed Linvatec Australia Pty Ltd
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