Events

Retiro De Equipo (Recall) de Device Recall Edwards Lifesciences Duraflo coated FemFlex II Femoral Arterial Cannula

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
    64782
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1111-2013
  • Fecha de inicio del evento
    2013-03-14
  • Fecha de publicación del evento
    2013-04-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117064
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Causa
    Two unsealed pouches were found at an edwards' distribution location in japan. incorrectly sealed pouches may result in a sterility barrier breach.
  • Acción
    Edwards Lifesciences sent an Urgent Field Safety Notice letter dated March 28, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of any affected product remaining in inventory and to return any unused devices to Edwards. A completed Acknowledgement Form should be faxed to Edwards at 800-422-9329 within three days of receiving the notice. Questions regarding the recall should be directed to Edwards Customer Services at 800-424-3278, 6:00AM - 4:30PM PST.

Device

Device Recall Edwards Lifesciences Duraflo coated FemFlex II Femoral Arterial Cannula
  • Modelo / Serial
    Model DIIFEMII018A, Lot 59337174
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.
  • Descripción del producto
    Edwards Lifesciences Duraflo coated Femoral Cannula. || Product Usage: || The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. || The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC
  • Dirección del fabricante
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Empresa matriz del fabricante (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA