Events

Recall of STERI-VAC GAS STERILIZER/AERATOR

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
    63649
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-02
  • 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
    During inspection of incoming components from a supplier 3m discovered a valve with incorrectly labeled "input" and "output" orientation. identified in a single lot of 100 valves this defect can result in the valve being installed backwards creating a remote possibility of valve failure. because one of the uses for these valves is to admit air into the sterilizer chamber and also prevent eo (ethylene oxide) from escaping a failure may result in eo being vented outside the sealed chamber during a limited period (<1 minute) during the eo injection phase of the cycle.

Device

STERI-VAC GAS STERILIZER/AERATOR
  • Model / Serial
    Model Catalog: 5XL (Lot serial: 722614); Model Catalog: 8XL (Lot serial: 722615); Model Catalog: 5XL (Lot serial: 722615); Model Catalog: 8XL (Lot serial: 722614)
  • Product Description
    STERI-VAC GAS STERILIZER/AERATOR
  • Manufacturer
    3M CANADA COMPANY

Manufacturer

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