Events

Retiro De Equipo (Recall) de ASP Sterrad Adapters

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
    15596
  • Fecha de inicio del evento
    2013-11-15
  • 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
    Issue 1: manufacturer has identified that the ifu for the sterrad booster and sterrad adaptor include incorrect instructions and potential consequences are failing to use the device when needed (potentially resulting in a lumen which is not sterile) or using the devices when not needed (potentially resulting in residual hydrogen peroxide left in the lumen), issue 2: the manufacturer has introduced a new verification tool that should be used with sterrad® boosters and sterrad® adaptors. this new tool is a checklist that should be printed and used to provide verification of the proper use of the sterrad® booster/adaptor before and after the sterrad® sterilization cycle.
  • Acción
    Instructions for use to be updated

Device

ASP Sterrad Adapters

Manufacturer

Advanced Sterilization Products