Events

Recall of FLUID WARMING SYSTEM W/TWO PRESSURE INFUSERS/BUILT IN AIR DETECTOR CLAMP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITHS MEDICAL CANADA LTD. (SIMS).

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
    144082
  • Event Risk Class
    II
  • Event Initiated Date
    2007-03-12
  • 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
    If the fluid warmer is powered off in an active alarm state the air detector/clamp will open and the air detector will become disabled.This could could allow the air to be delivered to the patient.

Device

FLUID WARMING SYSTEM W/TWO PRESSURE INFUSERS/BUILT IN AIR DETECTOR CLAMP

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    HC