Events

Retiro De Equipo (Recall) de STERRAD Boosters and Adaptors (used in STERRAD NX steriliser and contains hydrogen peroxide sterilant)

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-01217-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-11-15
  • 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-01217-1
  • 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
    It has been determined that the instructions for use (ifu) for the sterrad booster and sterrad adaptor include incorrect directions for when a sterrad booster and adapter i, ii and iii is required to be used. it has also been determined that the current procedures for fitting a sterrad booster do not adequately mitigate the risk of improper seal between the scope and the booster or inadequate cleaning of the adaptor/scope interface.
  • Acción
    J&J; Medical is advising customers of the correct procedure to follow and providing the updated instructions for use (IFU) to ensure the devices are properly sterilised. A new checklist has also been developed to provide additional verification of the proper use of the STERRAD booster/adapter before and after the STERRAD cycle. This action has been closed-out on 10/02/2016.

Device

STERRAD Boosters and Adaptors (used in STERRAD NX steriliser and contains hydrogen peroxide steri...
  • Modelo / Serial
    STERRAD Boosters and Adaptors (used in STERRAD NX steriliser and contains hydrogen peroxide sterilant)ARTG Number: 123602
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd