Events

Retiro De Equipo (Recall) de STERRAD 100S, STERRAD 50 and STERRAD NX Sterilisation Systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical 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-2013-RN-01355-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-23
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01355-1
  • 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
    Asp has received customer complaints by healthcare workers reporting odours/smells potentially emanating from the sterrad systems. odours/smells may also be related to normal breakdown of the oil used in the steriliser vacuum pump on the sterrad 100s ,sterrad 50 and/or sterrad nx . the reported odours/smells do not impact sterility of the devices processed within the sterrad systems. asp is investigating this issue to determine the source of the odour/smell and will continue to perform planned maintenance in accordance with each system’s schedule.
  • Acción
    If users observe any odours/smells, Johnson and Johnson Medical is requesting them to leave the room as a precaution and discontinue the use of STERRAD Systems until they are serviced.

Device

STERRAD 100S, STERRAD 50 and STERRAD NX Sterilisation Systems

Manufacturer

Johnson & Johnson Medical Pty Ltd