Retiro De Equipo (Recall) de Device Recall DURAMAX Hemodialysis Catheters, Stacked Tip 28 cm Straight Basic Kit,

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 Angiodynamics, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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, hemodialysis, implanted - Product Code MSD
  • Causa
    The product has the potential for a cross-lumen leak. one of the two leak testers that are used to perform the leak test on the duramax catheters was found to be faulty. the tester was not able to detect cross-lumen leaks. both testers were used during the manufacturing 100% leak test.
  • Acción
    Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.


  • Modelo / Serial
    Lots 978911, 980647, 981114, 981844, 982372, C68435, C68436, C68437, C68438, C68439, 981964
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide and St. Thomas, VI
  • Descripción del producto
    DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 28 cm Straight Basic Kit, Catalog Number/REF 10302804, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
  • Manufacturer


  • Dirección del fabricante
    Angiodynamics, Inc., 603 Queensbury Avenue, Queensbury NY 12804
  • Empresa matriz del fabricante (2017)
  • Source