Events

Retiro De Equipo (Recall) de Device Recall Advanta SST Bifurcated Grafts

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 Atrium Medical Corporation.

¿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
    65697
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2308-2013
  • Fecha de inicio del evento
    2013-07-12
  • Fecha de publicación del evento
    2013-09-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-07-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119919
  • 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
    Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
  • Causa
    Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field.
  • Acción
    Atrium Medical Corporation issued an Urgent Medical Device Safety Alert letter on July 16, 2013, via UPS to customers and e-mail to the field representatives that represent these accounts. The notification identifies the problem, product, and risk factors. In addition, it provides instructions how to handle product that may be affected. For questions customers were instructed to contact their Atrium Medical Customer Service at 603-880-1433 Prompt 1 or by e-mail at returns@atriummed.com

Device

Device Recall Advanta SST Bifurcated Grafts
  • Modelo / Serial
    Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
  • Descripción del producto
    Advanta SST Bifurcated Grafts >or= 6mm || Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Dirección del fabricante
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA