Events

Recall of GM-KO-67000-120 Paediatric 120” Circuit (Anaesthetic breathing circuit)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Koala Medical 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-00552-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00552-1
  • 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 o-ring in the swivel wye connector was out of specification and causing leaks in some of the affected circuits supplied.
  • Action
    Koala Medical is requesting their customers to quarantine the affected batches. Koala Medical will arrange for the recovery and replacement of the devices. This action has been closed-out on 12/08/2016.

Device

GM-KO-67000-120 Paediatric 120” Circuit (Anaesthetic breathing circuit)
  • Model / Serial
    GM-KO-67000-120 Paediatric 120” Circuit (Anaesthetic breathing circuit) Batch Numbers: 140813, 141222, 140915 and 141111 ARTG Number: 130242
  • Manufacturer
    Koala Medical Pty Ltd

Manufacturer

Koala Medical Pty Ltd