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 |
|
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 |