Events

Rappel de ULTRA 8 INTRA-AORTIC BALLOON - LIGHTWAVE SENSOR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ARROW INTERNATIONAL INC. (SUBSIDIARY OF TELEFLEX INCORPORATED).

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
    40619
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2009-02-10
  • 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
    Blue connector for 40cc iab not properly recognized by iab pump system.Fault in connector of pump tubing assembly may result in volume setting on pump defaulting to 2.5 or 5cc rather than 3040 or 50cc.

Device

ULTRA 8 INTRA-AORTIC BALLOON - LIGHTWAVE SENSOR
  • Modèle / numéro de série
    Model Catalog: IAB-05830-LWS (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-06840-U (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-05830-U (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-05840-U (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-05840-LWS (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-04840-U (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-S730C (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-04830-U (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-R950-U (Lot serial: >10 #scontact manufacturer); Model Catalog: IAK-02691 (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-S840C (Lot serial: >10 #scontact manufacturer); Model Catalog: IAK-02692 (Lot serial: >10 #scontact manufacturer)
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    ULTRA 8 IAB - LIGHTWAVE SENSOR
  • Manufacturer
    ARROW INTERNATIONAL INC. (SUBSIDIARY OF TELEFLEX INCORPORATED)

Manufacturer

ARROW INTERNATIONAL INC. (SUBSIDIARY OF TELEFLEX INCORPORATED)