Events

Rappel de ZILVER BILIARY STENT SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par COOK (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
    29760
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2003-08-25
  • 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
    The potential detachment within the introducer system's inner catheter could result in an inability to deploy the stent or could result in the potential for a segment to remain in the patient or endoscope.

Device

ZILVER BILIARY STENT SYSTEM
  • Modèle / numéro de série
    Model Catalog: ZILBS-10-6 (Lot serial: NUMEROUS LOTS); Model Catalog: ZILBS-10-4 (Lot serial: NUMEROUS LOTS); Model Catalog: ZILBS-8-8 (Lot serial: NUMEROUS LOTS); Model Catalog: ZILBS-8-6 (Lot serial: NUMEROUS LOTS); Model Catalog: ZILBS-8-4 (Lot serial: NUMEROUS LOTS); Model Catalog: ZILBS-6-8 (Lot serial: NUMEROUS LOTS); Model Catalog: ZILBS-6-6 (Lot serial: NUMEROUS LOTS); Model Catalog: ZILBS-6-4 (Lot serial: NUMEROUS LOTS); Model Catalog: SZBS-10-5.7 (Lot serial: NUMEROUS LOTS); Model Catalog: ZABS-10-6 (Lot serial: NUMEROUS LOTS); Model Catalog: ZABS-10-6-C (Lot serial: NUMEROUS LOTS); Model Catalog: ZABS-10-8 (Lot serial: NUMEROUS LOTS); Model Catalog: ZABS-10-8-C (Lot serial: NUMEROUS LOTS); Model Catalog: ZABS-10-4 (Lot serial: NUMEROUS LOTS); Model Catalog: ZABS-10-4-C (Lot serial: NUMEROUS LOTS); Model Catalog: ZILBS-10-8 (Lot serial: NUMEROUS LOTS); Model Catalog: SZBS-10-5.7-C (Lot serial: NUMEROUS LOTS); Model Catalog: SZBS-10-7.5-C (Lot serial: NUMEROUS LOTS); Model Catalog: SZBS-10-7.5 (Lot
  • Description du dispositif
    ZILVER EXPANDABLE METAL BILIARY STENT
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.