Quality & complianceOfficial

BfArM publishes MEDTRON urgent field safety notice for Syriflow MR infusion device

🇩🇪 BfArM field safety notices · Mon 26 Oct 2026

Germany's federal medicines and devices authority has posted a manufacturer advisory on Syriflow MR, but the public listing does not describe the problem or the corrective actions.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice from MEDTRON AG for its Syriflow MR device on 26 October 2026. The entry is filed under reference 46116/26.

BfArM places the product in the group "Injections / Infusions / Transfusions / Dialysis - infusion technology". Beyond that classification, the listing says only that further information and device details are in the manufacturer's enclosed Advisory Notice.

The web entry does not state the nature of the issue, which lots or serial numbers are affected, or what users are being asked to do. The Advisory Notice is available as a 310 KB PDF download, which BfArM notes does not meet accessibility standards.

As general context, a field safety notice is the manufacturer's communication to users about a safety-related action on a medical device already on the market. The authority lists these notices, but the content and required actions come from the manufacturer.

What it means for your team

  • Download and read the full MEDTRON Advisory Notice, as the BfArM listing gives no detail on the problem or required actions.
  • Check whether Syriflow MR devices are in use or stock at your sites, and identify affected units once the notice specifies them.
  • Quality and vigilance teams should log the notice under reference 46116/26 and follow their internal field safety corrective action procedures.
  • Do not infer severity or scope from the listing alone, since none is stated.

Official source: BfArM field safety notices ↗

Article written by VigiEye from the official source (BfArM field safety notices). AI-assisted; check the source before acting.

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