Events

Recall of GETINGE STEAM STERILIZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GETINGE SOURCING LLC..

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
    81799
  • Event Risk Class
    II
  • Event Initiated Date
    2000-05-05
  • 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
    Incident occured where a door opened during the sterilization cycle.

Device

GETINGE STEAM STERILIZER
  • Model / Serial
    Model Catalog: (Lot serial: Serial #s range from 97A58318); Model Catalog: (Lot serial: thru 99M60565.)
  • Product Description
    SERIES 200 STEAM STERILIZER
  • Manufacturer
    GETINGE SOURCING LLC.

Manufacturer

GETINGE SOURCING LLC.
  • Manufacturer Address
    ROCHESTER
  • Source
    HC