Events

Recall of MACROLYTE DISPERSIVE ELECTRODE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAYLIS MEDICAL COMPANY 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
    68829
  • Event Risk Class
    II
  • Event Initiated Date
    2014-05-16
  • 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
    There have been confirmed complaints regarding sparking no output and burning at the cord set connection. the gel line is making contact with the staples and over time the staples are corroding. when the pad is used heat builds up between the staple and foil contact surface. this can cause in some cases burning of the foam. ^.

Device

MACROLYTE DISPERSIVE ELECTRODE
  • Model / Serial
    Model Catalog: 440-2400 (Lot serial: >10 numbers contact mfg.)
  • Product Description
    Macrolyte Premie Dispertive Electrode
  • Manufacturer
    BAYLIS MEDICAL COMPANY INC.

Manufacturer

BAYLIS MEDICAL COMPANY INC.