Events

Retiro De Equipo (Recall) de Level 1 Hotline Fluid Warming Sets

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 Smiths Medical ASD 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
    16408
  • Fecha de inicio del evento
    2014-03-21
  • 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: Smiths Medical Australasia Pty Ltd, c/o KPMG, KPMG Centre, 18 Viaduct Harbour Avenue, Auckland
  • Causa
    Smiths medical has become aware of an issue with a limited number of warming sets with the potential for leakage from the injection port at the top of the warming set. if fluid leaks at the injection port, the leak is readily detectable by the clinician who would stop using the warming set and obtain a replacement. this could present a minor delay in therapy while a replacement warming set is obtained.
  • Acción
    Product to be returned to supplier

Device

Level 1 Hotline Fluid Warming Sets
  • Modelo / Serial
    Model: Models: L-70 and L-80, Affected: 73 and 5 specific lots respectively
  • Manufacturer
    Smiths Medical ASD Inc

Manufacturer

Smiths Medical ASD Inc