Events

Recall of ACTIVE CORD

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GYRUS ACMI 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
    22998
  • Event Risk Class
    II
  • Event Initiated Date
    2013-11-01
  • 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
    To advise users of an updated caution statement in the instructions for use (ifu) which cautions users that the reusable active cords have a restricted service life and should not be used for a period of more than one year. users are advised that damage or wear to the cord may compromise the integrity of the insulation and this may result in sparking smoke the risk of electrical shock or the risk of fire.

Device

ACTIVE CORD
  • Model / Serial
    Model Catalog: RAC-B (Lot serial: Lot: AA through MP AR BR)
  • Product Description
    Reusable active cord for Bovie style electosurgical generator
  • Manufacturer
    GYRUS ACMI INC.

Manufacturer

GYRUS ACMI INC.