Events

Rappel de FRENCH COLLEAGUE 3 CXE VOLUMETRIC PUMP

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BAXTER CORPORATION.

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
    19685
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-03-16
  • 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
    During an expanded review of records (see also recall number 53158) for the service activities performed by baxter corporation's local technical service centre it was found that required functional tests were potentially not performed on an additional number of colleague single channel and colleague triple channel volumetric infusion pumps.

Device

FRENCH COLLEAGUE 3 CXE VOLUMETRIC PUMP
  • Modèle / numéro de série
    Model Catalog: DNM9163L (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: DNM9163 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2M9163 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2M9163L (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2M9163LU (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2M8153 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8163 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8163LU (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM8153 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM8153L (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8151KL (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8151 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM9161L (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: DNM9161 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: DNM8151L (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8161L (Lot serial: >1000 NUMBERS CONTACT MFR); Mod
  • Description du dispositif
    FRENCH COLLEAGUE 3 CXE VOLUMETRIC PUMP
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION