Events

Recall of BARRIER Easywarm (Active Self Warming Blanket) and BARRIER Easywarm+ (Flexible Active Self Warming Blanket)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Molnlycke Health Care 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-01087-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01087-1
  • 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 affected blankets have a shelf life of 3 years but testing has indicated that blankets that are more than two years old, do not warm to the specified level of 10 hours.
  • Action
    Molnlycke Healthcare is informing customers to inspect their current stock. BARRIER Easywarm/Easywarm+ Products which are less than 2 years old (expiry date minus 1 year) can be used normally up until the 2 year mark. In the event that the customer has any BARRIER Easywarm/Easywarm+ products which are over 2 years old but less than 3 years, the customer is to contact the local Mölnlycke Sales Manager to arrange either a full refund or a replacement at no extra cost. This action has been closed-out on 31/08/2016.

Device

BARRIER Easywarm (Active Self Warming Blanket) and BARRIER Easywarm+ (Flexible Active Self Warmin...
  • Model / Serial
    BARRIER Easywarm (Active Self Warming Blanket) and BARRIER Easywarm+ (Flexible Active Self Warming Blanket) ARTG Number: 198120
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd