Events

Recall of EZ Clean Electrosurgical Electrodes

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
    53555
  • Event Risk Class
    Class 3
  • Event Number
    Z-0486-2010
  • Event Initiated Date
    2009-10-13
  • Event Date Posted
    2009-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85851
  • 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
    Product labels reference an incorrect expiration date. expiration date referenced on labels is 2104-07 instead of 2014-07.
  • Action
    A notification letter dated October 13, 2009 was sent to the first level consignees. Consignees were instructed to examine their stock, remove affected product and contact Megadyne Customer Service at 1-800-747-6110 (United States) or 1-801-576-9669 for product return instructions.

Device

EZ Clean Electrosurgical Electrodes
  • Model / Serial
    Lot Number: 91469.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (CA, FL, NE, LA, MT, OK, OR, PA, SC and UT) and New Zealand.
  • Product Description
    E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***" || The device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.
  • Manufacturer
    Megadyne Medical Products, Inc.

Manufacturer

Megadyne Medical Products, Inc.
  • Manufacturer Address
    Megadyne Medical Products, Inc., 11506 S State St, Draper UT 84020-9453
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA