PharmacovigilanceOfficial

FDA early alert: B. Braun recalls Streamline Bloodline Sets for Dialog+ over faulty connector bonding

🇺🇸 FDA MedWatch · Mon 02 Nov 2026

B. Braun says a missed solvent step during assembly left the dialyzer connector inadequately bonded on three lots, risking leaks, blood loss and air entry during haemodialysis.

The US Food and Drug Administration's device centre (CDRH) has published an early alert on a potentially high-risk issue with B. Braun Medical Inc.'s Streamline Bloodline Set for the Dialog+ haemodialysis system. The company has asked customers to remove certain bloodlines from use or sale.

The affected product is model SL-2010M2096, with UDI-DIs 04046964367786 and 04046964367779. Three lots are covered: A2600099, A2600128 and A2600136. According to B. Braun, a required solvent application step was not carried out during assembly, so the dialyzer connector is not adequately bonded.

As a result, the connector may detach or leak during priming or treatment. The source lists possible consequences including blood loss, clotting and occlusion of the extracorporeal circuit, and air entering the blood circuit. Treatment may have to be interrupted while the bloodline or circuit is replaced, and some patients may need clinical assessment, medical intervention or hospitalisation. In severe cases, significant blood loss could be life-threatening.

The alert says the dialysis machine's air detection system is expected to pick up air entry, which healthcare staff would then manage. In extremely rare circumstances, however, air that passes the detector could lead to air embolism and death. As of 10 October 2026, B. Braun had reported no serious injuries or deaths linked to the problem.

B. Braun sent a letter to affected customers on 20 October 2026. It asks them to inform all users and other concerned persons, and distributors to forward the notice to their consignees. Customers should also determine their inventory, stop using and quarantine the recalled product, and return it to the manufacturer. US customers can contact B. Braun at recalls@bbraunusa.com or (610) 849-1197. The FDA says it is still reviewing the information and will update its web page as significant new details emerge.

What it means for your team

  • Dialysis providers and distributors should check stock against model SL-2010M2096 and lots A2600099, A2600128 and A2600136, then quarantine and return any matches.
  • Quality teams should confirm that the recall notice has reached all users and, for distributors, all consignees, and keep records of the actions taken.
  • Pharmacovigilance and device-vigilance staff should capture any leaks, detachments, clotting or air-entry events involving these lots and report them to B. Braun and to FDA MedWatch.
  • The alert is an early notification and the FDA's review is continuing, so teams should monitor the FDA page for updates.

Official source: FDA MedWatch ↗

Article written by VigiEye from the official source (FDA MedWatch). AI-assisted; check the source before acting.

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