Events

Retiro De Equipo (Recall) de CareFusion Alaris SmartSite Needlefee connector

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por CareFusion Switzerland 317 Sarl.

¿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
    16318
  • Fecha de inicio del evento
    2014-02-27
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: CareFusion New Zealand 313 Limited, Unit 14, 13 Highbrook Drive, East Tamaki, AUCKLAND
  • Causa
    Carefusion has identified potential risks with model code 2000e and batch numbers noted below due to possible connection issues. the affected smartsite connector batches may unintentionally disconnect from a female luer, or may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. an inability to disconnect may require replacement of a line. leakage may also be observed if the connector disconnects from the female luer during infusion.
  • Acción
    Product to be returned to supplier

Device

CareFusion Alaris SmartSite Needlefee connector
  • Modelo / Serial
    Model: Model: 2000e, Affected: Lots: 13086446, 13095944, 13095778, 13106753, 13106848, 13096013, 13095675, 13106018
  • Manufacturer
    CareFusion Switzerland 317 Sarl

Manufacturer

CareFusion Switzerland 317 Sarl