Events

Retiro De Equipo (Recall) de Device Recall Aortic 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
    57951
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2196-2011
  • Fecha de inicio del evento
    2011-01-21
  • Fecha de publicación del evento
    2011-05-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98544
  • 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
    Bonding of the tip to the aortic cannula tubing may decline over time and may contribute to a drop in bond strength. possible tip separation.
  • Acción
    The firm, Edwards Lifesciences, sent an "URGENT PRODUCT RECALL - ACTION REQUIRED" letter dated January 21, 2011 it customers via Fed-Ex. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory for any of the lot numbers; return all unused product from their stock to Edwards; contact their Customer Service Organization at (800) 424-3278 to obtain a Returned Goods Authorization number and replacement product; complete and return the Aortic Perfusion Cannula Recall Response form via fax to: Edwards at (949) 250-3489, and return unused product to Edwards Lifesciences, 12050 Lone Peak Drive, Draper, UT 84020. If you have questions that have not been answered by this letter, call Edwards Customer Service at (800) 424-3278 from 8:00AM - 4:30PM Pacific Time.

Device

Device Recall Aortic Cannula
  • Modelo / Serial
    Lot Number: 58946275
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: CA only.
  • Descripción del producto
    Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. || The cannula perfuses blood to the ascending aorta during short-term (<6 hours) cardiopulmonary bypass procedures. The device is a Duraflo coated cannula intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
  • Manufacturer
    Edwards Lifesciences Llc

Manufacturer

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