Events

Recall of ConMed ThermoGuard Plus ABC Paediatric Dual Dispersive Electrodes

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by ConMed Linvatec Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00653-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-05-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00653-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

ConMed ThermoGuard Plus ABC Paediatric Dual Dispersive Electrodes
  • Model / Serial
    ConMed ThermoGuard Plus ABC Paediatric Dual Dispersive ElectrodesReference Number: 7-383Lot Codes: 141010X to 20150705XARTG Number: 130647
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd