Events

Field Safety Notices about Hemodialysis Conventional Product

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Baxter International, Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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.