Events

Recall of ConMed ECG Electrodes

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by ConMed Corporation.

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
    20250
  • Event Initiated Date
    2016-06-10
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
  • Reason
    Thermogard dual dispersive electrode pads are not compatible with some brands of electrosurgical generators using passive cqm (contact quality monitoring) systems.
  • Action
    Product to be destroyed

Device

ConMed ECG Electrodes
  • Model / Serial
    Model: ThermoGard Dial Dispersive Electrode Pads, Affected: CM-51-7710 lots 141010X to 20150705X, CM-7-382 lots 141010X to 201507005X, CM-7-382 lots 141010X 20150705X
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation