Events

Retiro De Equipo (Recall) de Device Recall MEGADYNE MEDICAL PRODUCTS "12FR" SUCTION COAGULATOR

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Megadyne Medical Products, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    67641
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1151-2014
  • Fecha de inicio del evento
    2014-02-27
  • Fecha de publicación del evento
    2014-03-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-07-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125887
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.
  • Descripción del producto
    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.
  • Dirección del fabricante
    Megadyne Medical Products, Inc., 11506 South State Street, Draper UT 84020-9453
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA