Events

Rappel de PRELUDE SHORT SHEATH INTRODUCER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par INTER V MEDICAL 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
    118752
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2009-04-30
  • 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 sidearm tubing may detach from the sheath during use. if this failure occures it may result in excessive patient blood loss and/or risk of blood-borne pathogen exposure to those in the surrounding area.

Device

PRELUDE SHORT SHEATH INTRODUCER
  • Modèle / numéro de série
    Model Catalog: PSS-7F-4MT (Lot serial: PSS-6F-4-018MTF661571); Model Catalog: PSS-6F-4MT (Lot serial: PSS-6F-4-018MTF661571); Model Catalog: PSS-5F-4MT (Lot serial: PSS-6F-4-018MTF661571); Model Catalog: PSS-5F-4-038MT (Lot serial: PSS-6F-4-018MTF635079); Model Catalog: PSS-6F-4-018MT (Lot serial: PSS-6F-4-018MTF635079); Model Catalog: PSS-5F-4-018MT (Lot serial: PSS-6F-4-018MTF635079); Model Catalog: PSS-8F-4MT (Lot serial: PSS-6F-4-018MTF635079); Model Catalog: PSS-7F-4MT (Lot serial: PSS-6F-4-018MTF635079); Model Catalog: PSS-6F-4MT (Lot serial: PSS-6F-4-018MTF635079); Model Catalog: PSS-5F-4MT (Lot serial: PSS-6F-4-018MTF635079); Model Catalog: PSS-5F-4-038MT (Lot serial: PSS-5F-4MTF686781); Model Catalog: PSS-6F-4-018MT (Lot serial: PSS-5F-4MTF686781); Model Catalog: PSS-5F-4-018MT (Lot serial: PSS-5F-4MTF686781); Model Catalog: PSS-8F-4MT (Lot serial: PSS-5F-4MTF686781); Model Catalog: PSS-7F-4MT (Lot serial: PSS-5F-4MTF686781); Model Catalog: PSS-6F-4MT (Lot serial: PSS-5F-4MTF686781); Model Catalog:
  • Description du dispositif
    PRELUDE SHORT SHEATH INTRODUCER
  • Manufacturer
    INTER V MEDICAL INC.

Manufacturer

INTER V MEDICAL INC.
  • Adresse du fabricant
    MONTREAL
  • Source
    HC