Events

Recall of SOFTRACE ECG ELECTRODES

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

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
    72722
  • Event Risk Class
    II
  • Event Initiated Date
    2010-11-10
  • 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
    Certain devices have a loose wire attachement that may lead to intermittent or poor signal quality.

Device

SOFTRACE ECG ELECTRODES
  • Model / Serial
    Model Catalog: 2310-003 (Lot serial: >10 lotscontact manufacturer); Model Catalog: 2331-003 (Lot serial: >10 lotscontact manufacturer); Model Catalog: 2321-003 (Lot serial: >10 lotscontact manufacturer); Model Catalog: 1720-003 (Lot serial: > 10 lotscontact manufacturer); Model Catalog: 1731-003 (Lot serial: > 10 lotscontact manufacturer); Model Catalog: 1741-003 (Lot serial: > 10 lotscontact manufacturer)
  • Product Description
    SOFTRACE ECG ELECTRODE
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    HC