Events

Rappel de Baxter MiniCap with Povidone-Iodine Solution

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
    18002
  • Date de mise en oeuvre de l'événement
    2015-02-11
  • 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
    Baxter received complaints indicating that the sponge of the minicap was fully separated from the cap, partially protruding from the cap, or missing. use of minicaps with sponges fully separated or missing from the caps may compromise the ability of the minicap to provide a sterile barrier protection at the end of the transfer when the transfer set is not connected to the patient line of the automated peritoneal dialysis (apd) cassette or continuous ambulatory peritoneal dialysis (capd) twin bag set-ups. this may increase the risk of peritonitis.
  • Action
    Manufacturer to issue advice regarding use

Device

Baxter MiniCap with Povidone-Iodine Solution

Manufacturer

Baxter Healthcare Corporation SA