Events

Rappel 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

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-00673-3
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-07-05
  • 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-00673-3
  • 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, 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.
  • Action
    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...
  • Modèle / numéro de série
    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