Events

Retiro De Equipo (Recall) de Unomedical Frazier Suction Instrument

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 Unomedical Sdn Bhd.

¿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
    20428
  • Fecha de inicio del evento
    2016-07-28
  • 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: Convatec (New Zealand) Ltd, WHK Gosling Chapman, Level 6, 51-53 Shortland Street, Auckland
  • Causa
    Ifu being issued due to complaints from the users in relation to breaking of the instrument at the junction of the handle and the metal tubing when pressure is applied at the tip. if the issue were to occur it would result in a loss of suction and loss of visibility in the surgical field.
  • Acción
    Instructions for use to be updated

Device

Unomedical Frazier Suction Instrument
  • Modelo / Serial
    Model: 309.02.006 309.02.008 309.02.008L 309.02.010 309.02.010L 309.02.012 309.02.012L, Affected: All lots
  • Manufacturer
    Unomedical Sdn Bhd

Manufacturer

Unomedical Sdn Bhd