Events

Rappel de Arrow Berman Angiographic Balloon Catheters

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 Arrow International Inc.

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
    14113
  • Date de mise en oeuvre de l'événement
    2013-01-22
  • 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Cause
    The manufacturer advises that the labelling for the product numbers listed above formerly referenced renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. arrow is in the process of updating the labelling and instructions for use for these products. in the meantime, when choosing an alternative contrast medium, health care providers are instructed to select a contrast medium with a viscosity of 8.4 centipoise or lower for use with the pressure and flow settings specified in the current ifu.
  • Action
    Manufacturer to issue advice regarding use

Device

Arrow Berman Angiographic Balloon Catheters
  • Modèle / numéro de série
    Model: Part numbers: AI-07130, AI-07130J, AI-07131, AI-07132, AI-07133, AI-07134, AI-07135, AI-07136, AI-07137, AI-07138, Affected: All lots
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc