Events

Recall of 3M Bair Hugger Full Access Underbody Blanket

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by 3M Australia 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-2018-RN-00102-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00102-1
  • 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
    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.
  • Action
    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.

Device

3M Bair Hugger Full Access Underbody Blanket
  • Model / Serial
    3M Bair Hugger Full Access Underbody BlanketModels 63500Manufactured between: 2nd October 2017 - 20th November 2017Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366Product Code: 70200791203ARTG Number: 218944
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    DHTGA