Events

Retiro De Equipo (Recall) de Device Recall FloTrac Sensor

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 Edwards Lifesciences, LLC.

¿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
    65984
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2189-2013
  • Fecha de inicio del evento
    2013-07-31
  • Fecha de publicación del evento
    2013-09-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121142
  • 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
    Transducer, blood-pressure, extravascular - Product Code DRS
  • Causa
    The edwards lifesciences flotrac sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the ifu was placed on top of the tyvek instead of being placed at the bottom of the box. there is no evidence available at this time that could validate the sterility of this incorrect packaging configuration.
  • Acción
    Edwards Lifesciences initiated a US recall via an Urgent Product Recall letter dated July 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that an Edweards Lifesciences representative would come to their facility to retrieve the affected device. A device replacement would be provided to the customer. Customers were asked to complete the enclosed Confirmation Form and give it to the Edwards Lifesciences representative that will come to their facility. For customers with questions were instruct4ed to call Edwards Customers Service at 1-800-424-3278. For questions regarding this recall call 972-410-7100.

Device

Device Recall FloTrac Sensor
  • Modelo / Serial
    595531157
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including MO and MI.
  • Descripción del producto
    "***Flo Trac Sensor Model MHD85***" || Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC
  • Dirección del fabricante
    Edwards Lifesciences, LLC, 1 Edwards Way, Irvine CA 92614-5688
  • Empresa matriz del fabricante (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA