Retiro De Equipo (Recall) de Device Recall DuraMax Chronic Hemodialysis Catheter

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
    Angiodynamics received customer complaints for breakage of the tunneler sleeve during product use.
  • Acción
    The firm, AngioDynamics, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 28, 2011 and response form via Certified Mail, Return Receipt Requested, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to identify and segregate the recalled lots; complete and return the enclosed DuraMax HemoDialysis Catheter Recall Reply Form via fax to: Attn: DuraMax HemoDialysis Catheter Recall Coordinator at 518-798-1360 (even if they don't have any product); and do not use the affected product, return and ship the recalled product to ANGIODYNAMICS (replacement product will be shipped upon receipt and confirmation of the returned product). If the customers are in immediate need for replacement product, they should fax the completed Recall Reply Form, along with a copy of the product label, to Customer Service at (518) 798-1360 or call us at (800) 772-6446, x1358 or x1363. If you have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please do not hesitate to contact your local sales representative or call ANGIODYNAMICS customer service at 1-800-772-6446 or email to:


  • Modelo / Serial
    Lots 500137, 500138, 527756, C28713
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip), DuraMax Stacked Tip 24 cm Str. Basic Kit, Catalog No./REF 10302803, STERILE --- AngioDynamics, Inc. 603 Queensbury, NY 12804 USA || The AngioDynamics DuraMax¿ Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.
  • Manufacturer


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