Events

Recall of CONMED CORE Suction Irrigation Handpieces (used to perform suction and irrigation during endoscopic procedures)

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-00844-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00844-1
  • 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 have identified that certain core suction irrigation product have creases in the packaging seal which sometimes can result in an open channel. these channels may compromise sterility of the product. there have been no reports of injuries as result of this issue.
  • Action
    CONMED Australia is advising users to discontinue use of the affected product and return it to ConMed for credit or replacement with unaffected product. This action has been closed-out on 17/02/2017.

Device

CONMED CORE Suction Irrigation Handpieces (used to perform suction and irrigation during endoscop...
  • Model / Serial
    CONMED CORE Suction Irrigation Handpieces (used to perform suction and irrigation during endoscopic procedures)Reference Numbers: CD8185, CD8190, CD8302Lot Numbers: 110609X to 20160308XManufactured between 9 June 2011 and 8 March 2016ARTG Number: 131326
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd