Events

Rappel de STERRAD 100S System Cassettes (To provide the hydrogen peroxide sterilant used in the STERRAD Steriliser)

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-2012-RN-00697-3
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-07-11
  • 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-2012-RN-00697-3
  • 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
    The manufacturer has discovered that printed information on the cassette results in the steriliser being unable to properly read the barcode. during the automated process used to print information on sterrad 100s system cassettes, an additional thirteenth (13th) bar was added to the barcode resulting in an unusable cassette. because the sterrad 100s system is designed to accept only properly coded cassettes, the sterrad 100s will reject all incorrect cassettes and display an error message: “incorrect cassette type”.
  • Action
    Quarantine and return affected product to Johnson & Johnson Medical.

Device

STERRAD 100S System Cassettes (To provide the hydrogen peroxide sterilant used in the STERRAD Ste...
  • Modèle / numéro de série
    STERRAD 100S System Cassettes (To provide the hydrogen peroxide sterilant used in the STERRAD Steriliser)Product Number: 10113Lot Number: 12A070ARTG Number: 123602
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd