Retiro De Equipo (Recall) de Cure Sleeve (a dental barrier sleeve for curing light to prevent cross contamination)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Kerr Australia Pty 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Kerr corporation received complaints that cases of cure sleeves labelled with part number 4513 contained inner boxes with part number 4500. there is a low risk associated with the use of this product because the smaller sleeve size is unlikely to able to be applied to the larger tips. if the product is used; there would be a remote potential for cross contamination due to the tearing of the sleeve.
  • Acción
    Kerr Corporation is contacting users to Recall affected units from the Market. This action has been closed-out on 15/07/2016.


  • Modelo / Serial
    Cure Sleeve (a dental barrier sleeve for curing light to prevent cross contamination)Part Numbers: 4513C or 4513-1Kit/Refill/Syringe Lot Numbers: 201403010110ARTG Number: 161520
  • Manufacturer