Events

Recall of ConMed Hyfrecator 2000 Electrosurgical Unit and Accessory Packages containing Handpiece Sheaths

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-2017-RN-00293-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00293-1
  • 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
    Conmed has identified that accessory packages contained within the hyfrecator 2000 carton were packaged in error by the manufacturer, with non-sterile handpiece sheaths (ref. 7-796-19) packaged in pouches that were labelled “sterile”. this could cause an end user to use a non-sterile sheath as if it were sterile. conmed has not received any reports that this mislabelling has resulted in injury or illness. only sheaths supplied in the original accessory package of affected hyfrecator cartons are mis-labelled.
  • Action
    ConMed is advising customers who have an affected Hyfrecator 2000 still in its original sealed carton (unopened) to return the product to ConMed for replacement. Customers who have an out-of-carton (opened) Hyfrecator 2000 are to check if they have any remaining sheaths (Ref. 70796-19) of the affected lots and to return unused affected sheaths for replacement.

Device

ConMed Hyfrecator 2000 Electrosurgical Unit and Accessory Packages containing Handpiece Sheaths
  • Model / Serial
    ConMed Hyfrecator 2000 Electrosurgical Unit and Accessory Packages containing Handpiece SheathsConMed Hyfrecator 2000 Electrosurgical UnitReference Number: 7-900-230Multiple Serial NumbersAccessory Package containing Handpiece SheathsReference Number: 7-796-19 Lot Numbers: 201511234, 201512074, 201512094, 201601064, 201603284ARTG Number: 130647
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd