Events

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

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
    65179
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0862-2014
  • Fecha de inicio del evento
    2013-05-16
  • Fecha de publicación del evento
    2014-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118138
  • 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
    Codman certas programmable valves used for hydrocephalus may not operate properly.
  • Acción
    Codman issued an Urgent Notice dated May 16, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Mitigation instructions are provided and if not followed or are not successful, either issue could lead to symptoms associated with under- or over-drainage. Units not implanted are to be returned. A U.S Acknowledgement Form and fax are requested to be completed and faxed to: 1-888-943-4193, or e-mail the form to codman8894@stericycle.com. If you have any questions on concerns in regards to this recall, please contact your Codman Representative or Stericycle at 1-888-943-2395.

Device

Device Recall CODMAN CERTAS Programmable Valve
  • Modelo / Serial
    Lot Codes:  CMBC2Y CMDCN9 CMJC48 CMLC6D CNCCLB CNCCZ4 CNDBRG CNDCNB CNHC8M CNJC4P CNKCL4 CNLCL1 CNMB8Y CNMDM0 CNNDHY CNPCLZ CPBC99 CPCC27 CPDBYJ CMNBFF CMNCDY CNCB6M CPBCRZ CPDCKL
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
  • Descripción del producto
    Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories || Product Code: 82-8805 || Product Usage: || The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
  • 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