Events

Recall of Bair Hugger® Blankets - Temperature Management System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by 3M Health Care Group.

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
    22550
  • Event Initiated Date
    2018-02-01
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: 3M New Zealand Ltd, 250 Archers Road, Glenfield, AUCKLAND 0627
  • Reason
    The manufacturer recently became aware through customer feedback that a design change to 3mtm bair hugger full access underbody warming blanket, model 63500 can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use.
  • Action
    Product to be returned to supplier

Device

Bair Hugger® Blankets - Temperature Management System
  • Model / Serial
    Model: , Affected: Lots numbers R10359, R10360, R10361, R10362, R10363, R10364, R10365, R 10366;
  • Manufacturer
    3M Health Care Group

Manufacturer

3M Health Care Group
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    NZMMDSA