Retiro De Equipo (Recall) de Vinyl examination/treatment glove, non-powdered

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Shantex 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
    Recall
  • ID del evento
    RC-2016-RN-01596-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-16
  • País del evento
  • Fuente del evento
    DHTGA
  • 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
    It has been found that shantex vinyl examination gloves have failed to demonstrate compliance with the standard (as.1011:2014) and are not suitable for medical/ biological applications because they do not provide an effective barrier suitable for medical or biological protection.
  • Acción
    Shantex is advising the distributor with affected stock to return them for credit. Retailers with affected stock are to return them to the distributor for credit.

Device

  • Modelo / Serial
    Vinyl examination/treatment glove, non-powderedBatch Numbers: 4-2015, 5-2015, 2-2016, 3-2016, 201401, 3-2015ARTG Number: 218314
  • Manufacturer

Manufacturer