Events

Rappel de GUIDING CATHETER STRAITGUT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par YOCAN MEDICAL SYSTEMS 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
    51707
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2000-05-18
  • 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
    Premature aging of the raw material and due to a weakness in the polyethylene material the tip of the catheter may break off or the hub may split from the device.

Device

GUIDING CATHETER STRAITGUT
  • Modèle / numéro de série
    Model Catalog: GC 6/95CM (Lot serial: 712173MA 602264MA 702231MA); Model Catalog: GC 5/95CM (Lot serial: 712173MA 602264MA 702231MA); Model Catalog: GCA 9/6 (Lot serial: 803209MA 712021MA.); Model Catalog: GCA 8/5 (Lot serial: 803209MA 712021MA.); Model Catalog: GCA 7/5 (Lot serial: 803209MA 712021MA.); Model Catalog: GCA 9/6 (Lot serial: 609202MA 706172MA 709268MA); Model Catalog: GCA 8/5 (Lot serial: 609202MA 706172MA 709268MA); Model Catalog: GCA 7/5 (Lot serial: 609202MA 706172MA 709268MA); Model Catalog: GCA 9/6 (Lot serial: 10062090A 507502MA 509599MA); Model Catalog: GCA 8/5 (Lot serial: 10062090A 507502MA 509599MA); Model Catalog: GCA 7/5 (Lot serial: 10062090A 507502MA 509599MA); Model Catalog: GCA 9/6 (Lot serial: 10013788A 10044163A); Model Catalog: GCA 8/5 (Lot serial: 10013788A 10044163A); Model Catalog: GCA 7/5 (Lot serial: 10013788A 10044163A); Model Catalog: GCA 9/6 (Lot serial: 505124M 10044161A 810211MA); Model Catalog: GCA 8/5 (Lot serial: 505124M 10044161A 810211MA); Model Catalog: GCA 7/
  • Description du dispositif
    GUIDING CATHETERS
  • Manufacturer
    YOCAN MEDICAL SYSTEMS INC.

Manufacturer

YOCAN MEDICAL SYSTEMS INC.