Events

Rappel de HEMODIALYSIS SYSTEM SERIES 1550 W/DOUBLE PUMP SINGLE NEEDLE

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
    72943
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2005-01-31
  • 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 reports of air bubbles in the tubing sets past the air detectorwithout an alarm alerting the operator of potential air in the tubing. potentially could cause air embolisms.

Device

HEMODIALYSIS SYSTEM SERIES 1550 W/DOUBLE PUMP SINGLE NEEDLE
  • Modèle / numéro de série
    Model Catalog: 5M5551 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 5M5538 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPP-D (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENA SPP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPP-DH (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPP-H (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3P (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3DPHA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000GIA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PHDP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PHA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PDP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PH (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3DPA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPX-O (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENA SPX (Lot serial: ALL SERIAL
  • Description du dispositif
    HEMODIALYSIS SYSTEM SERIES 1550
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION