Events

Rappel de INFUSOR LOW VOLUME

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
    95491
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-09-09
  • 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
    Baxter corporation initiated important safety information regarding the infusor and intermate portable elastomeric infusion systems. contact manufacturer for a listing of all product codes affected. baxter has received complaints for infusion flow rates greater than intended for the referenced portable elastomeric infusion systems. in many cases the complaint details an overinfusion of medication that is the result of uses inconsistent with the instructions for use.

Device

INFUSOR LOW VOLUME
  • Modèle / numéro de série
    Model Catalog: 2C1009KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1156KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1008KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1730K (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1734K (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1154KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1955KJP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1704P (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1702KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1701KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1087KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1063KP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1082KJP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1080KJP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1075KJP (Lot serial: > 10 contact manufacturer); Model Catalog: 2C1073KJP (Lot serial: > 10 cont
  • Description du dispositif
    INFUSOR LV - Portable Elastomeric Infusion System
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION