Retiro De Equipo (Recall) de Cardio Medical Products Inc.

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 Cardio Medical Products.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Dc-defibrillator, low-energy, (including paddles) - Product Code LDD
  • Causa
    Covidien received customer reports of arcing/sparking on the defibrillation electrode leadwire which may affect cardio medical products inc. defibrillator electrodes model number o101.
  • Acción
    Cardio Medical Products, Inc. issued an Urgent Medical Device Recall letter dated April 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and segregate any product with the affected lot numbers and return affected product according to the instructions for product credit by contacting the Customer Service group at 1-800-962-9888, option 1, then option 2, and reference the recall letter to request a Return Goods Authorizing (RGA). Customers were instructed to complete the enclosed Verification Form and return it to Covidien by fax to 800-895-6140, even if they did not have any of the affected lots. Customers were also instructed to report any issues to the Quality Assurance Group to ensure proper device reporting procedures are followed. Customers with questions were instructed to call 1-800-962-9888, option 8, then ext 2500. For questions regarding this recall call 973-586-9500.


  • Modelo / Serial
    510 K K103159  Part number O101  Lot numbers Y111412-2 Y111912-17 Y020613-03
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only || Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 || || (800) 227-3633 (973) 586-9624 FAX || Defibrillator
  • Manufacturer


  • Dirección del fabricante
    Cardio Medical Products, 385 Franklin Ave, Rockaway NJ 07866-4037
  • Empresa matriz del fabricante (2017)
  • Source