Clinical trialsOfficial

BfArM publishes urgent field safety notice for BD Connecta infusion connector

🇩🇪 BfArM field safety notices · Wed 11 Nov 2026

German regulator lists a notice from BD Switzerland Sarl on BD Connecta, but defect, affected lots and required actions appear only in the manufacturer's attached advisory.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 11 November 2026 relating to BD Connecta, a device made by BD Switzerland Sarl. The entry is filed under reference 52353/26.

BfArM classifies the product in its group for injections, infusions, transfusions and dialysis, specifically infusion kits. The register entry does not describe the nature of the problem, the lots or serial numbers concerned, or the measures users are expected to take.

The regulator instead refers readers to the manufacturer's Advisory Notice, which is attached to the entry as a 551KB PDF. BfArM notes that the file does not meet accessibility standards.

Field safety notices are the means by which manufacturers inform users of a corrective action concerning a marketed medical device. National authorities such as BfArM make them publicly available. Because the BfArM listing contains no technical detail, the PDF is the only place where the scope and instructions can be confirmed.

What it means for your team

  • Hospital pharmacies, procurement and device-safety officers should obtain the full Advisory Notice and check whether any BD Connecta stock they hold is within its scope.
  • Quality and vigilance teams should record the notice under reference 52353/26 and follow the manufacturer's instructions, including any required acknowledgement or response.
  • Do not infer the defect, risk level or corrective action from the BfArM listing, which provides none of these details.

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.

More Clinical trials All →