PharmacovigilanceOfficial

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

🇺🇸 FDA MedWatch · Tue 27 Oct 2026

FDA's device centre has flagged a potentially high-risk issue after B. Braun found a missing solvent step left some dialyzer connectors inadequately bonded in three lots.

The US Food and Drug Administration has issued an Early Alert, through its MedWatch programme, on B. Braun's Streamline Bloodline Set for Dialog+. The company has told customers to remove certain hemodialysis bloodlines from use or sale. The agency classes the matter as a potentially high-risk device issue and says it is still reviewing the information.

The affected product is model SL-2010M2096, with UDI-DI numbers 04046964367786 and 04046964367779. Three lots are involved: A2600099, A2600128 and A2600136. The set is a blood tubing set indicated for hemodialysis with the Dialog+ system.

B. Braun said a required solvent application step was not carried out during assembly, leaving the dialyzer connector inadequately bonded. The connector could detach or leak during priming or treatment. Possible consequences include blood loss, clotting and occlusion of the extracorporeal circuit, and air entering the blood circuit. The FDA notes that the dialysis machine's air detection system is expected to catch air ingress, but that in extremely rare cases air passing undetected could cause air embolism and death.

As of 10 October 2026, B. Braun had reported no serious injuries or deaths linked to the problem. On 20 October 2026 the company wrote to affected customers asking them to inform all users, determine their inventory, stop using and quarantine the product, and return it to the manufacturer. Distributors should pass the notice to their consignees. US customers can contact B. Braun at recalls@bbraunusa.com or (610) 849-1197, and adverse events or quality problems can be reported to MedWatch.

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 note the root cause: an omitted solvent application step in assembly, which is a process-control failure at the manufacturer.
  • Vigilance and device-safety staff should route any related leaks, detachments or air-in-line events to B. Braun and MedWatch, using the UDI-DI for traceability.
  • The FDA says it will update its web page as significant new information emerges, so teams should monitor it for changes in scope or classification.

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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