Events

Recall of Disposable Breathing Circuit Kit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare 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-2013-RN-00723-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00723-1
  • 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
    The y swivel body is moving out of shape and causing air to leak when turning the y swivel body.This recall action was carried out prior to the notification of the recall strategy to the tga.
  • Action
    GE Healthcare have requested users to remove affected devices from use and return units to GE Healthcare.

Device

Disposable Breathing Circuit Kit
  • Model / Serial
    Disposable Breathing Circuit Kit Catalogue Number: M1036002Serial Number: 124227ARTG Number: 119772
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd