Events

Retiro De Equipo (Recall) de STERRAD 100NX Cassette (Used to provide hydrogen peroxide sterilant used in the STERRAD NX Steriliser)

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-00811-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-02
  • 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-00811-1
  • 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
    Sterrad 100nx system cassettes are designed with a leak indicator on the outer package to provide a visual colour indication in the event hydrogen peroxide has leaked from the cassettes. the manufacturer has determined it does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the sterrad 100nx system cassette's 15 month shelf life.
  • Acción
    Johnson & Johnson Medical (JJM) is requesting end users to wear additional safety equipment (protective gloves and eye wear) in the event of handling product with an expired leak indicator as a precautionary measure for devices with an expiration date prior to 1 November 2014. End users are also requested to check for signs of indicator colour change or liquid leakage prior to opening the package. If the white indicator has turned red or a liquid leak is observed, customers are asked to dispose of the cassette immediately. Any indication of leakage should also be notified to JJM.

Device

STERRAD 100NX Cassette (Used to provide hydrogen peroxide sterilant used in the STERRAD NX Steril...
  • Modelo / Serial
    STERRAD 100NX Cassette (Used to provide hydrogen peroxide sterilant used in the STERRAD NX Steriliser)Part Number: 10144Expiration dates before November 1, 2014
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd