Retiro De Equipo (Recall) de Device Recall BARD(R) CRITICORE(R) MONITOR

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 C.R. Bard, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Urinometer, electrical - Product Code EXS
  • Causa
    Bmd has identified that some lots of criticore(r) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.
  • Acción
    Bard Medical sent an Urgent Medical Device Product Recall letter dated November 10, 2017. Action required: "Immediately examine your inventory and quarantine product subject to this recall. Please refer to CritiCore Monitor Affected Serial Numbers (Attachment 2) to help you locate the affected product serial number. Do not use or further distribute any affected product. "Please complete and return the accompanying Recall & Effectiveness Check Form (Attachment 1) attached to this letter regardless of whether you have any of the affected product. Additional instructions for product return are contained on the form. "If you have further distributed any units with the referenced serial numbers, please identify your customers and notify them at once of this product recall: Your notification should include a copy of this letter and the accompanying enclosures. This recall should be carried out to the user level." For further questions, please call (770) 784-6120


  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US Distribution and Internationally to Japan
  • Descripción del producto
    BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series || The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
  • Manufacturer


  • Dirección del fabricante
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Empresa matriz del fabricante (2017)
  • Source