Events

Recall of INFANT FLOW SENSOR SINGLE USE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HAMILTON MEDICAL AG.

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
    122940
  • Event Risk Class
    I
  • Event Initiated Date
    2015-05-11
  • 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
    Under some operating conditions it may be possible that water from the humidifier may condensate within the flow sensor measurement chamber and affect the flow measurement resulting in more volume being measured than being delivered to the patient. the instructions for use is being revised to inform the user of the correct position to have the flow sensor rest at.

Device

INFANT FLOW SENSOR SINGLE USE
  • Model / Serial
    Model Catalog: 155500 (Lot serial: all lots); Model Catalog: 260177 (Lot serial: all lots); Model Catalog: 260179 (Lot serial: all lots)
  • Product Classification
    Anesthesiology Devices
  • Product Description
    Hamilton Medical Infant Flow Sensor
  • Manufacturer
    HAMILTON MEDICAL AG

Manufacturer

HAMILTON MEDICAL AG