Events

Retiro De Equipo (Recall) de Smiths Medical 50 ml CADD® Medication Cassette

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 MD 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
    22071
  • Fecha de inicio del evento
    2017-10-13
  • 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
    The manufacturer has become aware that certain non flow-stop cadd medication cassette reservoirs may have been manufactured with an incorrect pressure plate. normally the pressure plate has a tunnel for the pumping tube, however on the affected models there is an arch on the pressure plate and pumping tube is pushed up., under delivery of medication may result from the tubing becoming partially or completely occluded when the affected cassette is attached to the pump.
  • Acción
    Product to be returned to supplier

Device

Smiths Medical 50 ml CADD® Medication Cassette
  • Modelo / Serial
    Model: 21-7001-24, Affected: Lot Nos: multiple (expiration date range March 2017 and March 2022)
  • Manufacturer
    Smiths Medical MD Inc

Manufacturer

Smiths Medical MD Inc