Events

Retiro De Equipo (Recall) de Device Recall EXXCEL AND EXXCEL SOFT EPTFE VASCULAR 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 Maquet Cardiovascular, LLC.

¿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
    55317
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1607-2010
  • Fecha de inicio del evento
    2010-03-26
  • Fecha de publicación del evento
    2010-05-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90545
  • 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
    This is an expansion of recall # z-866-2010, adding an additional two lots to the recall of exxcel soft stand wall eptfe vascular grafts due to a labeling mix up.
  • Acción
    The firm, MAQUET Cardiovascular, LLC, sent a "DEVICE REMOVAL IMMEDIATE ACTION REQUIRED" letter dated March 23, 2010, to all customers via Federal Express. The letter describes the product, problem and action to be taken by customers. The customers were instructed to examine their stock immediately to determine if they have any of the affected product from the lot, discontinue dispensing the lot and complete and return by fax (973-709-6511) the enclosed Field Action Response Form whether or not they have any affected products. Please contact your local MAQUET cardiovascular sales representative or Customer Service at 1-888-880-2874 for the exchange.

Device

Device Recall EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS
  • Modelo / Serial
    UPN M002004948580; Lot 11407455, Exp 12/2010.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA including states of TX, NJ, SC, MO, ID, TN, FL, CA, PA and Canada and Germany.
  • Descripción del producto
    EXXCEL Soft Thin Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. || Sterile || Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries.
  • Manufacturer
    Maquet Cardiovascular, LLC

Manufacturer

Maquet Cardiovascular, LLC
  • Dirección del fabricante
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA