Events

Recall of Fluoron Gas Tamponade EasyGas SF6

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by IQ Medical.

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-2014-RN-01327-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01327-1
  • 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
    Fluoron gmbh is voluntarily recalling the product due to a potential incorrect bottling of the longer acting gas c3f8 (12%) instead of sf6 (20%).
  • Action
    IQ Medical is requesting surgeons/healthcare professionals to notify their patients who received the affected products about the resulting extended prohibition of flying, diving and anaesthesia using nitrous oxide of 60 days from treatment. IQ Medical is also recalling any remaining stock in the market. This action has been closed-out on 08/03/2016.

Device

Fluoron Gas Tamponade EasyGas SF6
  • Model / Serial
    Fluoron Gas Tamponade EasyGas SF6Item Number: G-80950Lot Numbers: EG1 300614 and EG1 150714ARTG Number: 197089
  • Manufacturer
    IQ Medical

Manufacturer

IQ Medical