Events

Retiro De Equipo (Recall) de Siemens RAPIDLyte Arterial Blood Sampling Line Draw Syringes

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
    15856
  • Fecha de inicio del evento
    2013-12-23
  • 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    The manufacturer has identied an issue with the abl syringes when used with radiometer brand blood gas analysers. the plunger tip in the abl syringe does not remain stationary when the probe of the analyzer extends into the syringe. this can result in difficulties aspirating the sample or the plunger may get pushed out of the syringe.
  • Acción
    Manufacturer to issue advice regarding use

Device

Siemens RAPIDLyte Arterial Blood Sampling Line Draw Syringes
  • Modelo / Serial
    Model: Catalogue Numbers: 04180028, 00355281, 06194484, 06380806, Affected: Various lots
  • Manufacturer
    Smiths Medical ASD Inc

Manufacturer

Smiths Medical ASD Inc