Events

Recall of Karma Wheelchairs Item Name: Flexx(KM-8022)18*18

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Independent Home Care & Surgical Supplies 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-01157-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01157-1
  • 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
    Incorrect parts were supplied for karma wheelchairs. the bore diameter of the flexx side frame and front caster mount should be y8 to fit m8 screws. however, the flexx that was provided was y6 on the side frame and y8 on the caster mount. the production line did not realise the problem during production and assembled the caster mount to side frame by m6 screws. since the castor mount has bigger holes (y8), the wheelchair is likely to be wobbly while driving and more seriously, after a few months the m6 screws may fall off from the frame.This action was taken prior to consultation with the tga.
  • Action
    Independent Home Care & Surgical Supplies is contacting users to correct affected units. This action has been closed-out on 11/11/2016.

Device

Karma Wheelchairs Item Name: Flexx(KM-8022)18*18

Manufacturer

Independent Home Care & Surgical Supplies Pty Ltd
  • Source
    DHTGA