Events

Recall of FLEXICAIR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HILL-ROM CANADA.

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
    98526
  • Event Risk Class
    II
  • Event Initiated Date
    2009-06-04
  • 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
    It is possible for the identified devices to emit smoke from the blower box assembly. hazard of smoke inhalation and presence of smoke which can trigger smoke detection alarms.

Device

FLEXICAIR
  • Model / Serial
    Model Catalog: I3000 (Lot serial: model I3000); Model Catalog: M4000 (Lot serial: model I3000); Model Catalog: M4000 (Lot serial: model M4000); Model Catalog: I3000 (Lot serial: model M4000)
  • Product Description
    flexicair
  • Manufacturer
    HILL-ROM CANADA

Manufacturer

HILL-ROM CANADA