Events

Recall of Electrosurgical pencil.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Megadyne Medical Products, 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
    35124
  • Event Risk Class
    Class 2
  • Event Number
    Z-0780-06
  • Event Initiated Date
    2006-04-06
  • Event Date Posted
    2006-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45373
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Reason
    Surgical device packaging may be damaged and may compromise sterility.
  • Action
    Consignees were notified by letter on 04/06/2006.

Device

Electrosurgical pencil.
  • Model / Serial
    Catalog Number 0036H. Lot number: 51739
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including one VA facility in OH. No military consignees. Foreign distribution to France, India, Ireland, Japan, South Korea, Malaysia, Poland, UK.
  • Product Description
    Rocker Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster
  • Manufacturer
    Megadyne Medical Products, Inc

Manufacturer

Megadyne Medical Products, Inc
  • Manufacturer Address
    Megadyne Medical Products, Inc, 11506 S State St, Draper UT 84020-9453
  • Source
    USFDA