Events

Avis De Sécurité sur Hemodialysis Conventional Product

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Baxter International, Inc..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Baxter healthcare corporation issues a voluntary recall of the hemodialysis conventional product line with the above product codes and batch numbers due to customer complaints regarding fracture of the pre-dialysis artery expansion chamber at various stages of treatment. following an investigation, baxter found that there had been a change in the formulation of the material which could have led to increased material fragility and reduced impact resistance.

Device

Hemodialysis Conventional Product
  • Modèle / numéro de série
    114525 BL105 1701 to 1719 between 31.12.2019 and 04/30/2020 114526 BL121P 1701 to 1719 between 31.12.2019 and 04/30/2020 114527 BL130PSN 1701 to 1719 between 31.12.2019 and 04/30/2020 114557 BL208BD 1701 to 1719 between 31.12.2019 and 04/30/2020 114559 BL224BD 1701 to 1719 between 31.12.2019 and 04/30/2020
  • Manufacturer
    Baxter International, Inc.

Manufacturer

Baxter International, Inc.