Events

Recall of DISPOSABLE BLADE ELECTROSURGICAL ELECTRODE

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

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
    132943
  • Event Risk Class
    II
  • Event Initiated Date
    2010-07-29
  • 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 is a potential for peeling and melting of the insulation of the cautery tip of the ima / ent blade electrodes. this can result in the tip losing integrity leading to sparking or arcing of the current at the blade tip and result in a burn or electrical shock.

Device

DISPOSABLE BLADE ELECTROSURGICAL ELECTRODE
  • Model / Serial
    Model Catalog: 809335 (Lot serial: ALL)
  • Product Description
    IMA / ENT Blade Electrode
  • Manufacturer
    TELEFLEX MEDICAL

Manufacturer

TELEFLEX MEDICAL