Events

Rappel de REVERSE BERMAN ANGIOGRAPHIC BALLOON CATHETER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par TELEFLEX MEDICAL CANADA 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
    121376
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-03-07
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Arrow international has issued this voluntary field corrective action because the labeling for the products 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 labeling for these products. in the meantime when choosing 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 setting specified in the current ifu.

Device

REVERSE BERMAN ANGIOGRAPHIC BALLOON CATHETER
  • Modèle / numéro de série
    Model Catalog: AI-07035 (Lot serial: ALL); Model Catalog: AI-07138 (Lot serial: ALL); Model Catalog: AI-07037 (Lot serial: ALL); Model Catalog: AI-07130 (Lot serial: ALL); Model Catalog: AI-07130-J (Lot serial: ALL); Model Catalog: AI-07131 (Lot serial: ALL); Model Catalog: AI-07137 (Lot serial: ALL); Model Catalog: AI-07136 (Lot serial: ALL); Model Catalog: AI-07135 (Lot serial: ALL); Model Catalog: AI-07134 (Lot serial: ALL); Model Catalog: AI-07133 (Lot serial: ALL); Model Catalog: AI-07132 (Lot serial: ALL)
  • Description du dispositif
    REVERSE BERMAN ANGIOGRAPHIC BALLOON CATHETER
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.