Events

Rappel de STERRAD Boosters and Adaptors (used in STERRAD NX steriliser and contains hydrogen peroxide sterilant)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-01217-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-15
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01217-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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