Events

Rappel de ASP Sterrad Booster

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Advanced Sterilization Products.

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
    15596
  • Date de mise en oeuvre de l'événement
    2013-11-15
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Cause
    Issue 1: manufacturer has identified that the ifu for the sterrad booster and sterrad adaptor include incorrect instructions and potential consequences are failing to use the device when needed (potentially resulting in a lumen which is not sterile) or using the devices when not needed (potentially resulting in residual hydrogen peroxide left in the lumen), issue 2: the manufacturer has introduced a new verification tool that should be used with sterrad® boosters and sterrad® adaptors. this new tool is a checklist that should be printed and used to provide verification of the proper use of the sterrad® booster/adaptor before and after the sterrad® sterilization cycle.
  • Action
    Instructions for use to be updated

Device

ASP Sterrad Booster

Manufacturer

Advanced Sterilization Products