Events

Recall of MEDI-TRACE ECG ELECTRODES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GRAPHIC CONTROLS CANADA LTD..

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
    26784
  • Event Risk Class
    I
  • Event Initiated Date
    1998-05-21
  • 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
    The lead wire is not fully inserted into the connector prior to staking or staking processs iwas not consistently delivering the force necessary for an adequate crimp of the wire inside connector.

Device

MEDI-TRACE ECG ELECTRODES
  • Model / Serial
    Model Catalog: ECE F91-3 (Lot serial: HC80001 TO HC80016); Model Catalog: ECE F91 (Lot serial: HC80001 TO HC80016)
  • Manufacturer
    GRAPHIC CONTROLS CANADA LTD.

Manufacturer

GRAPHIC CONTROLS CANADA LTD.
  • Manufacturer Address
    GANANOQUE
  • Source
    HC