Events

Retiro De Equipo (Recall) de TIC Insulin Syringe

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 Tae-Chang Industrial Co Ltd.

¿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
    22649
  • Fecha de inicio del evento
    2018-02-22
  • 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: Terumo Australia Pty Ltd (NZ), c/- Healthcare Logistics, 56 Carrington Road, Mount Albert, Auckland 1025
  • Causa
    The manufacturer has identified that the individual peel packaging of the 0.5ml syringe had been mislabelled with the information for the 1.0ml syringe in relation to the unit increments. the current device label "0.5ml single use syringe for 100 units or less in two unit increments" should read "0.5ml single use syringe for 50 units or less in one unit increments.".
  • Acción
    Product to be returned to supplier

Device

TIC Insulin Syringe

Manufacturer

Tae-Chang Industrial Co Ltd