Events

Recall of Arceole C3F8 and SF6

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-2015-RN-01106-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-11-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01106-1
  • 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
    There is a possibility that 2 units of c3f8 (lot 15052502) have been incorrectly packaged in sf6 boxes. the product codes for these items are as-c3f8 and as-sf6 respectively. however, the box label, the blister label, the patient labels and the canister would be properly labelled as c3f8. there is a remote risk that the user may not identify the mislabelling before use, and incorrectly use the c3f8 gas at a concentration usually used for the sf6, which would be a maximum of 20% instead of 12%.
  • Action
    Sponsor to notify potentially affected customers. Customers to inspect and return affected sotck. Sponsor to replace affected stock. This action has been closed-out on 24/08/2016.

Device

Arceole C3F8 and SF6

Manufacturer

Device Technologies Australia Pty Ltd