Events

Retiro De Equipo (Recall) de Edwards Lifesciences Pressure Monitoring Kit and Set

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 Edwards Lifesciences LLC.

¿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
    19026
  • Fecha de inicio del evento
    2015-08-28
  • 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: Edwards Lifesciences (New Zealand) Limited, 171 Morrin Road, St John, Auckland 1072
  • Causa
    Edwards lifesciences is recalling specfic lots of product due to a flow restriction issue in a trifurcated iv set included in the pressure transducer kits. a restriction of the flow of iv fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.
  • Acción
    Product to be returned to supplier

Device

Edwards Lifesciences Pressure Monitoring Kit and Set
  • Modelo / Serial
    Model: PXMK2043 & PXMK2217, Affected: PXMK2043, Lot numbers 59994210, 60001412, 60020166 & 60030868 and PXMK2217 Lot numbers 59994267, 60020235 & 60030969
  • Manufacturer
    Edwards Lifesciences LLC

Manufacturer

Edwards Lifesciences LLC