Events

Recall of O-TWO ADULT VENTILATION TIMER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by O-TWO MEDICAL TECHNOLOGIES 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
    145786
  • Event Risk Class
    II
  • Event Initiated Date
    2015-10-27
  • 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
    Specific lots of the o-two adult ventilation timer may malfunction. the flash rate of the malfunctioning device may be much faster than it is labelled with a reported flash rate of 20 per minute instead of the labelled flash rate of 10 per minute.

Device

O-TWO ADULT VENTILATION TIMER
  • Model / Serial
    Model Catalog: 01BM1000 (Lot serial: 078734); Model Catalog: 01BM1000 (Lot serial: 081071)
  • Product Description
    O-TWO ADULT VENTILATION TIMER
  • Manufacturer
    O-TWO MEDICAL TECHNOLOGIES INC.

Manufacturer

O-TWO MEDICAL TECHNOLOGIES INC.