Events

Rappel de STERRAD 100S Cassettes

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-2014-RN-00281-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-03-04
  • 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-2014-RN-00281-1
  • 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
    The manufacturer, asp has identified that the misaligned barcodes may cause the cassette to be slightly out of position. the barcode on the sterrad 100s cassette is used to register the position of the cassette in the sterilizer. an out of position cassette may cause the first cycle on that cassette to cancel, or in extreme cases may cause the injection needles used to remove hydrogen peroxide from the sterrad 100s cassette to be damaged. the position of the barcode on the affected lots is variable and the probability of resulting damage to the injection needles is low.
  • Action
    Johnson & Johnson Medical is advising users to continue to use current stock until a replacement product has been provided. Affected stock can be returned to Johnson & Johnson Medical once unaffected stock has been received. This action has been closed-out on 12/02/2016.

Device

STERRAD 100S Cassettes
  • Modèle / numéro de série
    STERRAD 100S CassettesProduct Code: 10113Lot Numbers; 13I038, 13I046, 13I071, 13I072, 13I077, 13I078, 13I083, 13I084, 13I090, 13I121, 13K003, 13K074, 13K105, 13L021, 14A030 & 14A031ARTG Number: 123602
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd