Events

Retiro De Equipo (Recall) de Device Recall Trifuse Extension Sets

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
    67326
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0931-2014
  • Fecha de inicio del evento
    2014-01-16
  • Fecha de publicación del evento
    2014-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125294
  • 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 trifurcated extension set, models me 1224 and mp 9230, because they may have a defect in the trifurcated component that could result in a component leak.
  • Acción
    A customer notification letter and a distribution letter are dated 1/22/14 were sent to customers to inform them that CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230 may have a defect in the trifurcated component that could result in the component to leak. The letters inform the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclose, pre-addressed and postage paid, recall response card. Customers are instructed that once CareFusion receives the recall response card, the CareFusion Support Center will provide instructions for return of the affected lot number and replacement of the affected lot. Customers are instructed to contact CareFusion Support Center at (888) 562-6018, Customer advocacy at (888) 812-3266, customerfeedback@carefusion.com, or technical support at (888) 812-3229.

Device

Device Recall Trifuse Extension Sets
  • Modelo / Serial
    Trifurcated Extension Set, Model No. ME 1224,  Lot No. 11066540 11075718 11085047 11086237 11086676 11095178 11096312 11106045 11126756 12025801 12037064 12037127 12065225 12065586 12076327 12095460 13025322 13035514 13076233 13085002  Trifurcated Extension Set, Model No. MP 9230 Lot No. 13015666.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide in US and Canada
  • Descripción del producto
    Trifurcated Extension Set, model no. ME 1224. || Trifurcated Extension Set, model no. MP 9230.
  • 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