Recall of EZOX OXYGEN REGULATOR

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

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
    28534
  • Event Risk Class
    III
  • Event Initiated Date
    2010-11-11
  • Event Country
  • 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
    1-instructions for use have not been provided to customers including potential hazards associated with improper use and handling by improperly trained personnel could lead to serious injury 2-customers not aware of the recommended 5 year inspection for these regulators ensuring their continued integrity and safe working operation.

Device

  • Model / Serial
    Model Catalog: ALQ 1967 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    EZOX OXYGEN REGULATOR
  • Manufacturer

Manufacturer