Events

Rappel de Baxter CoSeal Surgical Hemostatic Sealant, 2ml and 4ml

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
    17037
  • Date de mise en oeuvre de l'événement
    2014-07-25
  • 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
    The recall is being conducted as a precautionary measure due to out of specification results observed at the 18-month time point (out of 18-month licensed shelf life to expiration) during a coseal stability study. the parameter that is out of specification is an indicator of possible failure for the product to gel appropriately. coseal's failure to gel does not represent risk for the patient's life. all other stability requirements were met.
  • Action
    Product to be returned to supplier

Device

Baxter CoSeal Surgical Hemostatic Sealant, 2ml and 4ml

Manufacturer

Baxter Healthcare Corporation SA