Events

Recall of 3M OPTREOZ STERILIZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by 3M CANADA COMPANY.

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
    79236
  • Event Risk Class
    III
  • Event Initiated Date
    2012-08-24
  • 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
    As a result of operator manual updates in march 2012 it was noted that the bill of material does not currently specify that a 3m branded operator manual be provided. the incorrect branded operator manual was provided at the time of sale of optreoz sterilizers.

Device

3M OPTREOZ STERILIZER
  • Model / Serial
    Model Catalog: 125-Z (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    3M Optreoz Sterilizer
  • Manufacturer
    3M CANADA COMPANY

Manufacturer

3M CANADA COMPANY
  • Manufacturer Address
    LONDON
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    HC