| 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 |
|
| 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 |