Events

Retiro De Equipo (Recall) de Device Recall Pyxis

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 CareFusion Corporation.

¿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
    53991
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1015-2013
  • Fecha de inicio del evento
    2009-11-20
  • Fecha de publicación del evento
    2013-03-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86996
  • 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
    Cabinet, table and tray, anesthesia - Product Code BRY
  • Causa
    The recall was initiated because carefusion has confirmed that when the pas 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.
  • Acción
    Carefusion sent a Safety Alert Notification letter dated January 13, 2010 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to ensure back-up procedures were in place in case of system down-time or lock-up, including review of the back-up procedures with staff. The letter included an update to the PAS 2000 User Guide. The letterstates that a CareFusion field representative will be contacting customers to make arrangements to apply warning labels to the PAS 2000 electronics doors. Customers were instructed to complete and return the Response Card included. For questions contact your local field support representative ot the Advocacy department at customer.advocacy@carefusion.com.

Device

Device Recall Pyxis
  • Modelo / Serial
    All Pyxis Anesthesia System Model 2000
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (Nationwide) including CANADA.
  • Descripción del producto
    Pyxis Anesthesia System Model 2000 (PAS 2000) || Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.
  • Manufacturer
    CareFusion Corporation

Manufacturer

CareFusion Corporation
  • Dirección del fabricante
    CareFusion Corporation, 10020 Pacific Mesa Blvd, San Diego CA 92121
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA