Events

Retiro De Equipo (Recall) de STERRAD® 50, STERRAD® 100S, STERRAD® 200, STERRAD® 100NX® and STERRAD® NX® System Cassettes

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 Advanced Sterilization Products.

¿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
    17793
  • Fecha de inicio del evento
    2014-12-03
  • 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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    The leak indicator on the asp sterrad® system cassettes packaging assembly may not function properly after exposure to hydrogen peroxide. sterrad® system cassette packaging assemblies are designed with a leak indicator on the inner package to provide a visual color indication in the event hydrogen peroxide has leaked from the cassettes.
  • Acción
    Instructions for use to be updated

Device

STERRAD® 50, STERRAD® 100S, STERRAD® 200, STERRAD® 100NX® and STERRAD® NX® System Cassettes

Manufacturer

Advanced Sterilization Products