Events

Retiro De Equipo (Recall) de STERRAD CYCLESURE 24 Biological Indicators within Validation Kits - (sterilisation process indicator) Biological Indicators within Validation Kits:STERRAD NX Validation Kit – STERRAD 100NX Validation Kit – STERRAD 100S/50 Validation Kit

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-2012-RN-00673-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-05
  • 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-2012-RN-00673-3
  • 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
    The manufacturer, asp, has determined that it does not have adequate data to support the entire duration of the product’s labelled shelf-life. as a result, the shelf life of sterrad cyclesure 24 biological indicator (bi) will be reduced by 9 months from the current expiry date on the product label.
  • Acción
    J&J; is asking customers to quarantine the affected lots that exceed the newly determined expiration date and return it to J&J.; Until the replacement stock is available, customers may continue to use the current inventory if it still has more than 9 month’s shelf life remaining. Product with labelled expiry date of May 2013 or later can be used.

Device

STERRAD CYCLESURE 24 Biological Indicators within Validation Kits - (sterilisation process indica...
  • Modelo / Serial
    STERRAD CYCLESURE 24 Biological Indicators within Validation Kits - Product codes: 14324, 20253, 20228, 20232 (sterilisation process indicator)Biological Indicators within Validation Kits:STERRAD NX Validation Kit – Product code 20253STERRAD 100NX Validation Kit – Product code 20228STERRAD 100S/50 Validation Kit – Product code 20232Multiple lot numbersARTG number: 134121
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd