Events

Recall of ConMed Electrosurgical Generators Monopolar/Bipolar

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    21156
  • Event Initiated Date
    2017-02-27
  • 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
    The accessory package contained within the hyfrecator 2000 carton was packaged in error by the manufacturer,with non-sterile ref 7-796-19 handpiece sheaths in pouches that were labelled sterile. this could cause an end user to use a non-sterile sheath as if it were sterile.
  • Action
    Product to be returned to supplier

Device

ConMed Electrosurgical Generators Monopolar/Bipolar
  • Model / Serial
    Model: , Affected: CONMED Hyfrecator® 2000 Electrosurgical Unit: Serial numbers 16020018, 16020032, 16020037, 16110158, 16160253, 16170278, 16170292, 16350421, 16380485, 16470584
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479