Events

Retiro De Equipo (Recall) de Volcano TrakBack II Disposable Pullback Device

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 Volcano 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
    69049
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2636-2014
  • Fecha de inicio del evento
    2014-08-13
  • Fecha de publicación del evento
    2014-09-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129418
  • 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, intravascular, diagnostic - Product Code DQO
  • Causa
    Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
  • Acción
    Volcano sent an Urgent Product Recall Notification letter dated August 13, 2014, to all customers who received the device in the last 25 months. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product and return unused devices to the Volcano distribution center. Customers were asked to prepare the attached inventory log and then contact Volcano Customer Service at 800-228-4728, option 4 to arrange for return of any affected product in their inventory. A credit would be issued for any returned product. Customers with questions were asked to call 800-228-4728. For questions regarding this recall call 978-439-3586.

Device

Volcano TrakBack II Disposable Pullback Device
  • Modelo / Serial
    Part number 91003: All Lots
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
  • Descripción del producto
    Volcano TrakBack II Disposable Pullback Device; || Sterile and nonpyrogenic; Single Use. || TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
  • Manufacturer
    Volcano Corporation

Manufacturer

Volcano Corporation
  • Dirección del fabricante
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA