Events

Retiro De Equipo (Recall) de Device Recall Marquet Heartstring II Proximal Seal System

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
    56868
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0940-2011
  • Fecha de inicio del evento
    2010-05-05
  • Fecha de publicación del evento
    2011-02-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94744
  • 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
    Clamp, vascular - Product Code DXC
  • Causa
    Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.
  • Acción
    The firm, MAQUET Getinge Group, sent an "URGENT DEVICE REMOVAL IMMEDIATE ACTION REQUIRED" letter dated May 5, 2010, to all customers via Federal Express. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to immediately examine their stocks to determine if they have any of the affected product, if found, discontinue dispensing (distributing) the lot and complete the Field Action Response Form; immediately contact accounts if they acted as a distributor, and acknowledge receipt of this notification whether or not they have any affected products by completing the Field Action Response Form via fax to (U.S.): 1-888-899-2874. If you have any additional questions, please contact your local MAQUET Cardiovascular sales representative or our Customer Service at 1-888-880-2874.

Device

Device Recall Marquet Heartstring II Proximal Seal System
  • Modelo / Serial
    Lot numbers 12895788, 12946718, 25002866, 25004647, 13029141, 25005045, 25005622
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries including: Japan, Mexico, Germany, Switzerland, Israel
  • Descripción del producto
    Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ || Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
  • 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