Events

Retiro De Equipo (Recall) de Device Recall SmartSite Needleless Connector

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 303, 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
    67346
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0925-2014
  • Fecha de inicio del evento
    2014-01-22
  • Fecha de publicación del evento
    2014-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125296
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    Carefusion is recalling the smartsite needlefree connector, model number 2000e, because of connection issues. the affected smartsite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. leakage may also be observed if the connector disconnects from the female luer during in.
  • Acción
    The firm, CareFusion, sent an "URGENT: Medical Device Recall Notification" letter dated January 22, 2014 to customers. The letter described the product, problem and actions to be taken. Customers were instructed to discontinue use of the listed lot numbers, contact CareFusion for a replacement of the affected lots, and if you have inventory of the listed products immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card. All recalled product should be returned directly to the distributor from whom it was purchased. If you have any question, contact your distributor directly or call the CareFusion Support Center at numbers below. For recall related questions, customers are instructed to contact CareFusion Support center at (888) 562-6018. For adverse event reports, customers are instructed to contact Customer advocacy at (888) 812-3266 or email customerfeedback@carefusion.com. For technical questions regarding the Alaris System, customers are instructed to contact technical support at (888) 812-3229.

Device

Device Recall SmartSite Needleless Connector
  • Modelo / Serial
    Lot Numbers:  13045933 13046117 13086415 13086446 13095237 13095302 13095324 13095579 13095674 13095675 13095777 13095778 13095808 13095944 13096011 13096012 13096013 13096158 13096723 13096770 13105584 13106017 13106018 13106096 13106260 13106355 13106451 13106497 13106498 13106753 13106754 13106847 13106848 13106849 13115209 13115210 13115317 13115733 13115734 13115871 13115872 13125361 13125362
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Australia, Canada and New Zealand.
  • Descripción del producto
    SmartSite Needleless Connector, Model No. 2000E || The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle.
  • Manufacturer
    CareFusion 303, Inc.

Manufacturer

CareFusion 303, Inc.
  • Dirección del fabricante
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA