Events

Retiro De Equipo (Recall) de Device Recall Zilver 518 Vascular Self Expanding Stent

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 Cook Ireland Ltd..

¿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
    61451
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2309-2012
  • Fecha de inicio del evento
    2012-01-05
  • Fecha de publicación del evento
    2012-09-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108136
  • 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
    Stent, iliac - Product Code NIO
  • Causa
    Cook ireland received a product complaint from japan on december 22nd, 2011. the complainant reported that a 5 french zilver vascular stent (part number ziv5-18-125-8-80 from lot# cf694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. after further examination, the user determined that the product was a 6 french zilver vascular stent (part number ziv6-35.
  • Acción
    The firm, Cook Medical, sent a letter dated February 13, 2012 to foreign consignee. The letter described the product, problem and actions taken. The firm stated that re-training of the relevant personnel has been carried out; they will continue to monitor to identify potential emerging trends and further corrective and preventive action will be considered in an effort to avoid the recurrence of similar events. If you have any question contact in US: Customer Relations Manager at 800.346.2686.ext 2222 or email: rita.harden@cookmedical.com; OUS: Customer Quality Supervisor at +353 61 239343.

Device

Device Recall Zilver 518 Vascular Self Expanding Stent
  • Modelo / Serial
    Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA (nationwide) and country of: Japan.
  • Descripción del producto
    Zilver 518 Vascular Self Expanding Stent || The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.
  • Manufacturer
    Cook Ireland Ltd.

Manufacturer

Cook Ireland Ltd.
  • Dirección del fabricante
    Cook Ireland Ltd., O'holloran Road,, National Technological Park, Limerick, Peroc Ireland
  • Empresa matriz del fabricante (2017)
    Cook Group Incorporated
  • Source
    USFDA