Events

Recall of Device Recall MEGADYNE MEDICAL PRODUCTS "12FR" SUCTION COAGULATOR

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
    67641
  • Event Risk Class
    Class 2
  • Event Number
    Z-1151-2014
  • Event Initiated Date
    2014-02-27
  • Event Date Posted
    2014-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125887
  • 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
    Megadyne medical products, inc. is voluntarily recalling hand control 12fr suction coagulator with 10ft cord and 132405 holster, sterile, disposable, lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected.
  • Action
    Megadyne Medical Product sent an Urgent Medical Device Recall letter dated February 27, 2014, to all affected customers with follow-up phone calls and emails. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed toexamine their inventory immediately to determine if they have any of the affected product. If so, customers were instructed to remove the product from service and contact Megadyne Customer Service at 1-801-576-9669 or 1-800-747-6110 for return authorization and replacement or credit. If customers have distributed any the affected product, they were instructed to immediately contact their distribution points to have the product returned to Megadyne. Customers with questions were instructed to contact Customer Service at 1-800-747-6110 or 1-801-576-9669 or email Regulatory @Megadyne.com. For questions regarding this recall call 801-576-9669.

Device

Device Recall MEGADYNE MEDICAL PRODUCTS "12FR" SUCTION COAGULATOR
  • Model / Serial
    Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.
  • Product Description
    Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. || This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.
  • Manufacturer
    Megadyne Medical Products, Inc.

Manufacturer

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