Events

Retiro De Equipo (Recall) de Device Recall MaxGuard Extension Set with Injection Site and 0.2 micron filter

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
    76439
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1464-2017
  • Fecha de inicio del evento
    2017-02-20
  • Fecha de publicación del evento
    2017-02-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153214
  • 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 maxguard extension set with injection site and 0.2 micron filter because of reports of separation and/or leakages between the y-connector and tubing.
  • Acción
    An Urgent Medical Device Recall Notification letter will be sent to customers on February 20, 2017 to inform them that CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter model number ME3305 Lot Number 16016790. Customers are informed that CareFusion has received reports of separation and/or leakages between theY-connector and tubing. Customers are informed that leakages from an extension set can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, or underinfusion. The letter informs the customers of the actions to be taken and for recall related questions to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266.

Device

Device Recall MaxGuard Extension Set with Injection Site and 0.2 micron filter
  • Modelo / Serial
    Lot No. 16016790
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution including MA and MD
  • Descripción del producto
    MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
  • 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