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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00102-1
Product Name/Description 3M Bair Hugger Full Access Underbody Blanket

Models 63500

Manufactured between: 2nd October 2017 - 20th November 2017

Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366

Product Code: 70200791203

ARTG Number: 218944
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/02/2018
Responsible Entity 3M Australia Pty Ltd
Reason/Issue 3M recently became aware that a design change to the Bair Hugger Full Access Underbody Blanket, Models 63500, can make them more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use. The health risk associated with this issue is if blankets are only partially inflated during use in surgery, it could result in incomplete warming therapy. Loss of therapy may lead to in advert perioperative hypothermia.
This recall does not affect any other lots of 3M Bair Hugger Full Access Underbody Blanket
Recall Action Recall
Recall Action Instructions 3M is advising users to inspect inventory and quarantine affected stock of the specified lot numbers immediately to prevent further use. 3M will be in contact with users to arrange collection of affected stock.

This action has been closed out on 07/11/2018
Contact Information 1300 363 878 - Customer Service Support