Events

Retiro De Equipo (Recall) de Codman EDS 3 CSF External Drainage 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 Codman & Shurtleff, Inc..

¿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
    69262
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0089-2015
  • Fecha de inicio del evento
    2014-09-15
  • Fecha de publicación del evento
    2014-10-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130121
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Causa
    Tubing within the system that drains csf may leak or disconnect from the joints and may result in over- or under-drainage of csf from the ventricular system or introduction of air into the ventricular system (pneumocephalus).
  • Acción
    Codman Neuro sent an Urgent Notice dated September 12, 2014, to all affected customers via overnight mailing and OUS customers notified via email the week of September 15, 2014. Accounts were requested to isolate all inventory of the affected product and return to Stericycle at the following address: Stericycle 2670 Executive Drive, Suite A Attn: Event #8894 Indianapolis, IN 46241 For patients currently being managed with the EDS 3 System, the system should be replaced immediately. In the case where no substitute drainage system is immediately available, the EDS 3 System may continue to be used until an alternative product can be obtained. If you have any questions or concerns regarding this notification, please contact your local Codman Neuro Representative or Scientific and Medical Affairs at SciMedAffairs@its.jnj.com or (866) 685-7325. For questions regarding this recall call 508-880-8000.

Device

Codman EDS 3 CSF External Drainage System
  • Modelo / Serial
    All lots with expiration on or before August 2017 (2017-08)
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to: United Arab Emirates Argentina Austria Australia Aruba Belgium Bahrain Bolivia Brazil Bahamas Canada Switzerland Chile People's Republic of China Columbia Costa Rica Cyprus Czech Republic Germany Algeria Estonia Egypt Spain Finland France Gabon Great Britain French Guiana Greece Guatemala Hong Kong Croatia Hungary Ireland Israel India Iran Italy Jordan Kenya Kuwait Kazakhstan Lebanon Lithuania Luxembourg Latvia Mauritius Mexico Malaysia Mozambique New Caledonia Nigeria Netherlands Norway New Zealand Oman Panama Peru Poland Palestine Portugal Reunion Romania Serbia Russian Federation Rwanda Saudi Arabia Sweden Singapore Slovenia Slovakia Tunisia Turkey Trinadad And Tobago Taiwan Ukraine Uruguay Venezuela Mayotte South Africa
  • Descripción del producto
    Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) || Catalog Number: 82-1730 || Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
  • Manufacturer
    Codman & Shurtleff, Inc.

Manufacturer

Codman & Shurtleff, Inc.
  • Dirección del fabricante
    Codman & Shurtleff, Inc., 325 Paramount Drive, Raynham MA 02767
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA