Events

Retiro De Equipo (Recall) de Device Recall CODMAN CERTAS Programmable Valves

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
    67793
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1468-2014
  • Fecha de inicio del evento
    2013-12-13
  • Fecha de publicación del evento
    2014-04-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-04-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126333
  • 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
    Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted codman certas programmable valves.
  • Acción
    Codman Neuro issued notification packages dated 12/13/13 to Domestic Hospitals and international accounts. Specific letters and associated inclusion of the additional aids, include A) a valve setting verification guide with instructions for use with x-ray images, and B) a plastic valve cut out overlay). A response reply form was included to be completed and returned to confirm effectiveness of the notification.

Device

Device Recall CODMAN CERTAS Programmable Valves
  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: || 82-8800 In Line Valve Only || 82-8801 In Line Valve with Catheter and Accessories || 82-8802 In Line Valve with Unitized Catheter and Accessories || 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories || 82-8804 In Line Valve only with SIPHONGUARD Device || 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories || 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories || 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories || 82-8850 Certas Therapeutic Management System
  • 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