Events

Recall of Futuro Quick Strap Ankle Support

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by 3M Australia 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-2018-RN-00116-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00116-1
  • 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 manufacturer is aware that there is natural rubber latex (1%) in the futuro quick strap ankle support. currently packaging of this product does not have an explicit caution statement in relation to latex.The existing caution statement available on this product is "caution: some individuals may be sensitive to neoprene or neoprene blend rubber. if a rash develops, discontinue use and consult a physician".Individuals that are sensitive to latex may develop an allergic reaction.No alleged medical complaints regarding this product have been received in australia during its period of distribution.This recall does not affect any other 3m products.
  • Action
    3M is advising pharmacies to quarantine affected stock and return it to the distributor. 3M will arrange collection of affected devices from distributors.

Device

Futuro Quick Strap Ankle Support
  • Model / Serial
    Futuro Quick Strap Ankle Support Product Code: 47736EN3M Code: 70005091510All batch/lot numbers are affectedARTG Number: 214679
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    DHTGA