Events

Rappel de CORDIS SUPER TORQUE MB MARKER BAND FLUSH CATHETER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    62237
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-11-24
  • 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
    Cordis has issued a field safety notice to provide important information concerning a potential for marker band dislodgement in the super torque mb angiographic catheter during endovascular procedures when the catheter is stretched or elongated and important recommendations for clinical use.

Device

CORDIS SUPER TORQUE MB MARKER BAND FLUSH CATHETER
  • Modèle / numéro de série
    Model Catalog: 532-598D (Lot serial: 13467459); Model Catalog: 532-598C (Lot serial: 13467459); Model Catalog: 532-598B (Lot serial: 13467459); Model Catalog: 532-598A (Lot serial: 13467459); Model Catalog: 532-598D (Lot serial: 13460575); Model Catalog: 532-598C (Lot serial: 13460575); Model Catalog: 532-598B (Lot serial: 13460575); Model Catalog: 532-598A (Lot serial: 13460575); Model Catalog: 532-598D (Lot serial: 15277504); Model Catalog: 532-598C (Lot serial: 15277504); Model Catalog: 532-598B (Lot serial: 15277504); Model Catalog: 532-598A (Lot serial: 15277504); Model Catalog: 532-598D (Lot serial: 13431281); Model Catalog: 532-598C (Lot serial: 13431281); Model Catalog: 532-598B (Lot serial: 13431281); Model Catalog: 532-598A (Lot serial: 13431281); Model Catalog: 532-598D (Lot serial: 15206620); Model Catalog: 532-598C (Lot serial: 15206620); Model Catalog: 532-598B (Lot serial: 15206620); Model Catalog: 532-598A (Lot serial: 15206620); Model Catalog: 532-598D (Lot serial: 15247189); Model Catalog:
  • Description du dispositif
    SUPER TORQUE MB ANGIOGRAPHIC CATHETER
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.