Events

Rappel de POLYFLUX REVACLEAR

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
    148834
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2016-10-05
  • 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 is issuing a voluntary product recall for one (1) lot of revaclear max dialyzers due to the potential presence of particulate matter within the blood side of the dialyzer. the issue was identified as a result of one customer complaint received for the presence of black fibers and dust within the dialyzer. there is the potential of visually not detecting the presence of foreign material in the blood side of the dialyzer. when the dialyzer is used the particles may become dislodged by flow of the dialysate and may reach the vascular system of the patient which could lead to adverse health consequences. there have been no reports of injuries associated with this issue.

Device

POLYFLUX REVACLEAR

Manufacturer

BAXTER CORPORATION