Events

Recall of Hypothermia Caps, Mittens and Slippers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Control Medics 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-00121-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00121-1
  • 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, southwest technologies are recalling all hypothermia products including caps, mittens and slippers for the intended use of reduction of chemotherpay induced alopecia, onycholysis and skin toxicity. the devices are misbranded for use during chemotherapy treatments, and may lead to frostbite to digits on patients with, but not limited to diabetic neuropathy, raynaud's disease, distal metastasis, distal arteriopathy and cold intolerance. there have been reports of serious injuries overseas as a result of this issue.
  • Action
    Control Medics is advising customers to discontinue use of affected products immediately. Customers are advised to quarantine all affected stock to prevent further use and return it to Control Medics.

Device

Hypothermia Caps, Mittens and Slippers
  • Model / Serial
    Hypothermia Caps, Mittens and SlippersProduct Name: Hypothermia CapProduct Number: cap-610Batch Number: 052016C Product Name: Hypothermia SlippersProduct Number: SL3000Batch Number: 041116DProduct Name: Hypothermia MittsProduct Number: TM7008Batch Number: 042016CARTG Number: 272254 (cancelled)
  • Manufacturer
    Control Medics Pty Ltd

Manufacturer

Control Medics Pty Ltd
  • Source
    DHTGA