Events

Recall of ReTurnBelt wipeable

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Active Medical 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-00586-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00586-1
  • 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
    Handicare received two complaints stating that while demonstrating the function of returnbelt, when exposed to high load, the strap ripped at the heat welded seam. this action was undertaken prior to notifying the tga.
  • Action
    Handicare AB requested all belts with the affected lot number to be returned. Handicare AB through Active Medical is refunding the amount paid.

Device

ReTurnBelt wipeable
  • Model / Serial
    ReTurnBelt wipeable Article Numbers: 6133,6134,6135,6136All Belts in Lot 1402SDistributed during 2014 and until March 2015ARTG Numbner: 144735
  • Manufacturer
    Active Medical Supplies Pty Ltd

Manufacturer

Active Medical Supplies Pty Ltd