Rappel de COLLEAGUE GUARDIAN ENHANCED CXE COLOR 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
    23457
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-02-13
  • Pays de l'événement
  • 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 a review of records for the service activities performed by baxter corporation's local test service it was identified that required functional tests were potentially not performed on the identified colleague volumetric infusion pumps.

Device

  • Modèle / numéro de série
    Model Catalog: 2M9161 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 2M9161L (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 2M8153 (Lot serial: 11100952CT); Model Catalog: 2M8161 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: DMN 8151 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 2M8161LU (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: DNM9161 (Lot serial: 18010089JF); Model Catalog: DNM9161L (Lot serial: 18010089JF); Model Catalog: DNM9161 (Lot serial: 18020088JF); Model Catalog: DNM9161L (Lot serial: 18020088JF); Model Catalog: DNM9161 (Lot serial: 17060477JF); Model Catalog: DNM9161L (Lot serial: 17060477JF); Model Catalog: DNM9161 (Lot serial: 17080209JF); Model Catalog: 2M8163LU (Lot serial: 15010161TC); Model Catalog: DNM 8153 (Lot serial: 15010161TC); Model Catalog: 2M8163 (Lot serial: 15010161TC); Model Catalog: 2M8153 (Lot serial: 15010161TC); Model Catalog: 2M8163LU (Lot serial: 15010004TC); Model Catalog: DNM 8153 (Lot serial: 15010004TC); Model Catalog: 2M8163 (
  • Description du dispositif
    COLLEAGUE GUARDIAN CXE COLOR PUMP
  • Manufacturer

Manufacturer