Events

Recall of DEFIBRILLATION PADS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by THE STEVENS COMPANY LIMITED.

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
    17825
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-18
  • 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
    Cardiac science has determined that the affected lot may exhibit higher than expected electrical impedance over time. if electrode impedance becomes too high the g3 aed will fail the electrode self-test performed by the aed and it will not be rescue ready.

Device

DEFIBRILLATION PADS
  • Model / Serial
    Model Catalog: 9131 (Lot serial: 141125-02)
  • Product Description
    POWERHEART G3 DEFIBRILLATION ELECTRODES
  • Manufacturer
    THE STEVENS COMPANY LIMITED

Manufacturer

THE STEVENS COMPANY LIMITED