Events

Retiro De Equipo (Recall) de Z-Hyalin Multipack

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 Hyaltech 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
    14267
  • Fecha de inicio del evento
    2013-03-04
  • 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: Carl Zeiss (NZ) Ltd, 22 Fremlin Place, Avondale, Auckland 1026
  • Causa
    Manufacturer has become aware that the sterile integrity of the pouches contained within the multipack cartons may be compromised due to an inadequate seal on the pouches.This has been observed in a small number of pouches. the sterility of the syringe contents are not affected in any way, however, the fault may affect the sterility of the outside surface of the syringe., (this recall is an extension of the hyaltechs fsn medsafe ref #13920).
  • Acción
    Product to be returned to supplier

Device

Z-Hyalin Multipack
  • Modelo / Serial
    Model: , Affected: 1192BB, 1192BD
  • Manufacturer
    Hyaltech Ltd

Manufacturer

Hyaltech Ltd