Events

Recall of Freedom Healthcare Quad Walkers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Gainsky 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-2017-RN-01130-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01130-1
  • 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 sponsor has become aware of a fault where the front right wheel of specific quad walkers has either worked loose, or the wheel has sheared off the frame of the walker. when the wheel shears off, the wheeler becomes unstable and the user may become unsteady on their feet and lose their balance.
  • Action
    1. Users are to find the information sticker on the walker and look at the batch number stamped on the sticker. Photographs of the location of the sticker to assist customers will be provided with the customer letter. Verify the unit is affected stock. 2. Take the walker to the place of purchase where you will be offered a replacement walker or a refund of your purchase price. 3. A representative will contact distributors to arrange to recover any stock of the defective products held and replace them with sound items. For further information, please see https://www.tga.gov.au/alert/freedom-healthcare-quad-walkers

Device

Freedom Healthcare Quad Walkers
  • Model / Serial
    Freedom Healthcare Quad WalkersModel Numbers: BRO209 and BRO199Batch Numbers: FHFHCBR13 and FHFHCBR15Manufactured in June 2016 and October 2016 ARTG Number: 137219
  • Manufacturer
    Gainsky Pty Ltd

Manufacturer

Gainsky Pty Ltd