Events

Rappel de STERRAD 100S, STERRAD 50 and STERRAD NX Sterilisation Systems

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-01355-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-23
  • 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-01355-1
  • 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
    Asp has received customer complaints by healthcare workers reporting odours/smells potentially emanating from the sterrad systems. odours/smells may also be related to normal breakdown of the oil used in the steriliser vacuum pump on the sterrad 100s ,sterrad 50 and/or sterrad nx . the reported odours/smells do not impact sterility of the devices processed within the sterrad systems. asp is investigating this issue to determine the source of the odour/smell and will continue to perform planned maintenance in accordance with each system’s schedule.
  • Action
    If users observe any odours/smells, Johnson and Johnson Medical is requesting them to leave the room as a precaution and discontinue the use of STERRAD Systems until they are serviced.

Device

STERRAD 100S, STERRAD 50 and STERRAD NX Sterilisation Systems

Manufacturer

Johnson & Johnson Medical Pty Ltd