Field Safety Notices about Minicap

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.

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
  • Event Source
  • 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 is adding contraindication statements to address iodine allergy for baxter’s peritoneal dialysis products which contain iodine (i.E., povidone-iodine) or for which iodine use is recommended. the ifu will include instructions for users to not use the product if there is a known history of allergic reaction to iodine. the changes in the contraindication statements are not a result of a change in any of the products, but are a further enhancement of existing baxter labeling. see above for a list of product codes and descriptions. .


  • Model / Serial
  • Manufacturer