Events

Retiro De Equipo (Recall) de Blood Donor Set/Quad/46347

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 Maco Pharma SA.

¿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
    20892
  • Fecha de inicio del evento
    2016-12-01
  • 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: MacoPharma Australia Pty Ltd, BDO Auckland, L8, 120 Albert St, Auckland 1010
  • Causa
    The manufacturer was informed of a number of fast filtrations on the reference npt6280la. this has caused an absence of effective filtration through the media of the lcrd2 filter. this defect is linked to a partial absence of the weld in the media caused by poor positioning (fold or gap) of the last polyester layer in the mattress.
  • Acción
    Manufacturer to issue advice regarding use

Device

Blood Donor Set/Quad/46347
  • Modelo / Serial
    Model: , Affected: filter type LCRD2
  • Manufacturer
    Maco Pharma SA

Manufacturer

Maco Pharma SA
  • Empresa matriz del fabricante (2017)
    Macopharma
  • Source
    NZMMDSA