Events

Rappel de ADMINISTRATION SETS AND DRUG RESERVOIRS FOR 6060 INFUSION PUMPS

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
    27666
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2004-12-01
  • 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
    Manufacturer has received notifications of free-flow situations and investigation identified a missing platen assembly from a cassette on one set and this wil prevent the pump from occluding the tubing.

Device

ADMINISTRATION SETS AND DRUG RESERVOIRS FOR 6060 INFUSION PUMPS
  • Modèle / numéro de série
    Model Catalog: 560500250 (Lot serial: R03K24278); Model Catalog: 560500100 (Lot serial: R03K24278); Model Catalog: 560112L (Lot serial: R03K24278); Model Catalog: 560112GEL (Lot serial: R03K24278); Model Catalog: 2M9862 (Lot serial: R03K24278); Model Catalog: 2M9861 (Lot serial: R03K24278); Model Catalog: 2M9860 (Lot serial: R03K24278); Model Catalog: 2M9859 (Lot serial: R03K24278); Model Catalog: 2M9858 (Lot serial: R03K24278); Model Catalog: 2M9857 (Lot serial: R03K24278); Model Catalog: 2M9856 (Lot serial: R03K24278); Model Catalog: 2L9003 (Lot serial: R03K24278); Model Catalog: 560500250 (Lot serial: R03K19229); Model Catalog: 560500100 (Lot serial: R03K19229); Model Catalog: 560112L (Lot serial: R03K19229); Model Catalog: 560112GEL (Lot serial: R03K19229); Model Catalog: 2M9862 (Lot serial: R03K19229); Model Catalog: 2M9861 (Lot serial: R03K19229); Model Catalog: 2M9860 (Lot serial: R03K19229); Model Catalog: 2M9859 (Lot serial: R03K19229); Model Catalog: 2M9858 (Lot serial: R03K19229); Model Catalog: 2
  • Description du dispositif
    6060 SOLUTION SETS WITH AUTO CLAMP
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION