Events

Recall of Adult Circuit Tubing (Oxygen therapy delivery system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fisher & Paykel Healthcare 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-2012-RN-01156-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01156-1
  • 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
    Fisher and paykel healthcare has become aware that one batch of tubes supplied to fisher and paykel healthcare may contain hole damage. if this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy.
  • Action
    Fisher and Paykel is recalling affected product and is replacing it with unaffected tubing.

Device

Adult Circuit Tubing (Oxygen therapy delivery system)
  • Model / Serial
    Adult Circuit Tubing (Oxygen therapy delivery system)Product Code: 900MR068Lot Numbers: 110810 & 111020ARTG Number: 129354
  • Manufacturer
    Fisher & Paykel Healthcare Pty Ltd

Manufacturer

Fisher & Paykel Healthcare Pty Ltd