Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01087-1
Product Name/Description BARRIER Easywarm (Active Self Warming Blanket) and BARRIER Easywarm+ (Flexible Active Self Warming Blanket)

ARTG Number: 198120
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 13/11/2015
Responsible Entity Molnlycke Health Care Pty Ltd
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.
Contact Information 02 8977 2114 - Molnlycke health Care