Events

Recall of BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM - WARMING BLANKETS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by 3M CANADA COMPANY.

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
    107207
  • Event Risk Class
    III
  • Event Initiated Date
    2018-02-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The affected blankets are more susceptible to unintended occlusion of airflow resulting in partial or limited inflation during use. if blankets are only partially inflated during use in surgery there is potential for incomplete warming therapy to be given to a patient.

Device

BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM - WARMING BLANKETS
  • Model / Serial
    Model Catalog: 63700 (Lot serial: R10363); Model Catalog: 63500 (Lot serial: R10364); Model Catalog: 63500 (Lot serial: R10363); Model Catalog: 63700 (Lot serial: R10362); Model Catalog: 63500 (Lot serial: R10362); Model Catalog: 63700 (Lot serial: R10361); Model Catalog: 63500 (Lot serial: R10361); Model Catalog: 63700 (Lot serial: R10360); Model Catalog: 63500 (Lot serial: R10360); Model Catalog: 63700 (Lot serial: R10359); Model Catalog: 63500 (Lot serial: R10359); Model Catalog: 63700 (Lot serial: FR10361); Model Catalog: 63500 (Lot serial: FR10361); Model Catalog: 63700 (Lot serial: R10366); Model Catalog: 63500 (Lot serial: R10366); Model Catalog: 63700 (Lot serial: R10365); Model Catalog: 63500 (Lot serial: R10365); Model Catalog: 63700 (Lot serial: R10364)
  • Product Description
    Bair Hugger Full Access Underbody Blanket
  • Manufacturer
    3M CANADA COMPANY

Manufacturer

3M CANADA COMPANY
  • Manufacturer Address
    LONDON
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    HC