Events

Rappel de FEM-FLEX II VENOUS CANNULA

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par EDWARDS LIFESCIENCES (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
    49930
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-03-26
  • 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
    Through post market surveillance edwards lifesciences has identified a potential health risk to patients regarding the use of fem-flex ii femoral arterial cannula sizes 8 10 and 12 french only. edwards has received one customer complaint regarding a released wire located at the tip area of the cannula which was identified prior to use. although the condition does not affect the functionality of the cannula there is potential patient safety risk if a protruding wire is not detected prior to use.

Device

FEM-FLEX II VENOUS CANNULA
  • Modèle / numéro de série
    Model Catalog: FEMII012V (Lot serial: 59873252); Model Catalog: FEMII008A (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FEMII008V (Lot serial: 59873252); Model Catalog: FEMII012V (Lot serial: 59849124); Model Catalog: FEMII010V (Lot serial: 59849124); Model Catalog: FEMII008V (Lot serial: 59849124); Model Catalog: FEMII012V (Lot serial: 59796683); Model Catalog: FEMII010V (Lot serial: 59796683); Model Catalog: FEMII008V (Lot serial: 59796683); Model Catalog: FEMII012V (Lot serial: 59723307); Model Catalog: FEMII010V (Lot serial: 59723307); Model Catalog: FEMII008V (Lot serial: 59723307); Model Catalog: FEMII012V (Lot serial: 59890924); Model Catalog: FEMII010V (Lot serial: 59890924); Model Catalog: FEMII008V (Lot serial: 59890924); Model Catalog: FEMII012V (Lot serial: 59849119); Model Catalog: FEMII010V (Lot serial: 59849119); Model Catalog: FEMII008V (Lot serial: 59849119); Model Catalog: FEMII012V (Lot serial: 59751074); Model Catalog: FEMII010V (Lot serial: 59751074); Model Catalog: FEMII008V (Lo
  • Description du dispositif
    FEM-FLEX II VENOUS CANNULA
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.