Events

Recall of ELECTROSURGICAL MONOPOLAR FORCEPS REUSABLE

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

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
    23294
  • Event Risk Class
    III
  • Event Initiated Date
    2012-07-06
  • 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
    This recall has been initiated due to an issue with the product labeling whereby the label tip is identified as (0.5mm) and actually measures (1.0mm).

Device

ELECTROSURGICAL MONOPOLAR FORCEPS REUSABLE
  • Model / Serial
    Model Catalog: 41604 (Lot serial: 019737)
  • Product Description
    BAYONET FORCEPS 8.5'' SERRATED 1.0MM TIPS ELECTROSURGICAL/MONOPOLAR FORCEPS/REUSABLE
  • Manufacturer
    OLSEN MEDICAL LLC

Manufacturer

OLSEN MEDICAL LLC
  • Manufacturer Address
    LOUISVILLE
  • Manufacturer Parent Company (2017)
    Olsen Medical Llc
  • Source
    HC