Events

Retiro De Equipo (Recall) de Device Recall R2 Adult R2 NonRadiolucent Multifunction Electrodes

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 ConMed Corporation.

¿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
    60701
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0856-2012
  • Fecha de inicio del evento
    2011-03-31
  • Fecha de publicación del evento
    2012-01-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106250
  • 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
    Electrode, electrodcardiograph, multi-function - Product Code MLN
  • Causa
    The specific lot was assembled without the rivet cover.
  • Acción
    ConMed Corporation sent a Urgent Medical Device Recall Letter dated March 25, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately stop use of the device and return it to ConMed Corporation. Please review your inventory for any of the devices listed on Attachment I. If you do not have any devices to return, please follow the instructions in the letter and complete Attachment II, indicating you have no devices and fax it to 315-624-3225. Please complete the attached Business reply form. We apologize for any inconvenience this will cause you or your staff. For further questions please call (315) 797-8375.

Device

Device Recall R2 Adult R2 NonRadiolucent Multifunction Electrodes
  • Modelo / Serial
    Lot 1010194
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) and the countries of Canada, Belgium, Germany and Hong Kong.
  • Descripción del producto
    R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERILE, MADE IN USA, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13507 || This device, when connected to a monitor/defibrillator has the ability to monitor the electro-cardio function (ECG) of the patient. The device, when electrically activated by the monitor/defibrillator can pace the heart rate of the patient and may also transmit the electrical current to the patient for cardio-conversion. This is a non-sterile, disposable device.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Dirección del fabricante
    ConMed Corporation, 525 French Road, Utica NY 13502
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    USFDA