Events

Rappel de Baxter Healthcare Bladder Irrigation Connector

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 Baxter Healthcare Corporation SA.

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
    16052
  • Date de mise en oeuvre de l'événement
    2014-01-22
  • 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: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Cause
    Manufacturer has been reviewing the stability data generated to support labelling claims on its products and found that the microbial barrier requirements, provided by means of the packaging material to guarantee sterility of the product were not met for the named product code. as a result the manufacturer cannot guarantee sterility of the product over the whole claimed shelf life. the medical risk has been assessed as high and therefore manufacturer has made the decision to recall all batches of this product code.
  • Action
    Product to be returned to supplier

Device

Baxter Healthcare Bladder Irrigation Connector

Manufacturer

Baxter Healthcare Corporation SA