Events

Retiro De Equipo (Recall) de Device Recall CareFusion SmartSite Gravity Blood Set

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
    64204
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0832-2013
  • Fecha de inicio del evento
    2012-12-20
  • Fecha de publicación del evento
    2013-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115553
  • 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¿ gravity blood set as a result of a potential for separation at the connection of the drip chamber and tubing . the separation may be observed at priming or observed during use. if a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.
  • Acción
    Carefusion sent an "URGENT: Medical Device Recall Notification" letter dated January 21, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to return all recalled product directly to the distributor from whom it was purchased immediately, complete and return the enclosed pre-addressed and postage paid mandatory Customer Recall Response Card and to contact your distributor directly, or call the Carefusion Support Center, if you have any questions. For questions Recall Related Questions contact CareFusion Support Center at 888-562-6018; 7am to 4pm (Pacific). For technical questions contact Technical Support at 888-812-3229, 7am to 5pm (Pacific).

Device

Device Recall CareFusion SmartSite Gravity Blood Set
  • Modelo / Serial
    Lot number 12055225
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.
  • Descripción del producto
    CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.
  • Manufacturer
    Carefusion 303 Inc

Manufacturer

Carefusion 303 Inc
  • Dirección del fabricante
    Carefusion 303 Inc, 3750 Torrey View Ct, San Diego CA 92130-2622
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA