Events

Recall of Device Recall Electrosurgery cautery tip

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
    25265
  • Event Risk Class
    Class 2
  • Event Number
    Z-0468-03
  • Event Initiated Date
    2002-12-20
  • Event Date Posted
    2003-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25499
  • 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
    The metal substrate cautery tip may break during use.
  • Action
    On 12/20/2002, all consignees were notified by letter to return all affected product.

Device

Device Recall Electrosurgery cautery tip
  • Model / Serial
    Catalog Number 0600. Lots 00664, 00845, 10038, 10190, 10541, 10669, 10703, 10766, 10951, 11110, 11356, 20046, 20219, 20520, 20592, 20757, 20777, 20856, 20997, 21075.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Foreign distribution to Australia, Belgium, Canada, Italy, Korea, New Zealand, Sweden.
  • Product Description
    Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE
  • Manufacturer
    Megadyne Medical Products, Inc

Manufacturer

Megadyne Medical Products, Inc
  • Manufacturer Address
    Megadyne Medical Products, Inc, 11506 South State Street, Draper UT 84020
  • Source
    USFDA