Events

Retiro De Equipo (Recall) de GCA (Gravity Compensating Accessory)

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 Integra LifeSciences Corp..

¿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
    50065
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0458-2009
  • Fecha de inicio del evento
    2008-10-03
  • Fecha de publicación del evento
    2008-12-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-10-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74612
  • 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
    Central Nervous System Fluid Shunt and Components - Product Code JXG
  • Causa
    Integra neurosciences has become aware that certain gravity compensating accessory implants have the potential for csf leakage under certain conditions.
  • Acción
    Urgent: Product Recall Notification letters, dated 10/3/08, were sent out on October 9, 2008. Letters explain the reason for the recall and the catalog and lot numbers affected. If the product has been implanted, it is recommended that the patient be monitored periodically using the standard of care determined appropriate by the patient's attending physician. If the product is found in inventory, customers are asked to quarantine the product and contact their Integra Sales Rep for assistance and for arrangements for product return. A Recall Acknowledgement and Return Form is to be completed and returned to Integra for reconciliation purposes.

Device

GCA (Gravity Compensating Accessory)
  • Modelo / Serial
    Catalog number: 903-430, Lot Numbers 148792, 149247; Catalog Number 903-435, Lot Numbers 147796, 148790; Catalog Number 903-440; and Lot Numbers 147795, 149246
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - MI, IL, NY, IN, CA, IN and NC and Carnegie, Victoria, Melbourne, Australia.
  • Descripción del producto
    Gravity Compensating Accessory; || High Pressure Range, Sterile, Single Use, Rx only. CSF shunt accessory. || Manufacturer: Integra Neuro Sciences Implants, SA, Cedex, France; || distributed by: Integra NeuroSciences, Plainsboro, NJ 08536 || The GCA is an implantable device designed to be used in conjunction with implanted systems which shunt cerebrospinal fluid CSF from the cerebral ventricles to an appropriate drainage site.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.