Events

Retiro De Equipo (Recall) de Device Recall Optiflux F250NRe Hemodialyzer

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 Fresenius Medical Care Holdings, 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
    57947
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1622-2011
  • Fecha de inicio del evento
    2011-02-16
  • Fecha de publicación del evento
    2011-03-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97801
  • 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
    Dialyzer, High Permeability With or Without Sealed Dialysate System - Product Code KDI
  • Causa
    There is an increased risk of an internal blood leak.
  • Acción
    FMCNA notified consignees on 2/16/11 by telephone and follow-up with an Urgent FMCNA Optiflux F250NRe Recall letter via Certified Mail, return Receipt requested. The firm states in the letter that there is an increased risk of an internal blood leak affecting a small percentage of the two lots of dialyzers. They are asking customers to examine their inventory, to discontinue use, and segregate the affected product in a secure place. Customers are to contact their FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return product. Used dialyzers should not be returned. If there are any questions, Customer Service should be contacted.

Device

Device Recall Optiflux F250NRe Hemodialyzer
  • Modelo / Serial
    Lot numbers:  10HU02012, Expiration Date: 06/30/2013; and  10LU02016, Expiration Date: 09/30/2013.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and Canada.
  • Descripción del producto
    Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius Polysulfone. || Intended for use as an artificial kidney system to the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration and hemodiafiltration.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.

Manufacturer

Fresenius Medical Care Holdings, Inc.
  • Dirección del fabricante
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • Empresa matriz del fabricante (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA