Recall of Fluoron Gas Tamponades (Intraocular injection of ophthalmic gases)Models: EasyGas Sulphur Hexafluoride (SF6), EasyGas Hexafluoroethane (C2F6), EasyGas Octafluoropropane (C3F8)

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-2013-RN-00266-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-03-28
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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
    There have been reports where the tamponades have displayed a potential loss of gas volume due to the design of the syringe packaging.
  • Action
    IQ Medical is asking customers to quarantine all affected units, if any remaining in the field and return any remaining units.

Device

  • Model / Serial
    Fluoron Gas Tamponades (Intraocular injection of ophthalmic gases)Models: EasyGas Sulphur Hexafluoride (SF6), EasyGas Hexafluoroethane (C2F6), EasyGas Octafluoropropane (C3F8)Lot Numbers: G-80950, G-80960 & G-80970ARTG Number: 197089
  • Manufacturer

Manufacturer