The FDA is warning facilities to remove three lots of B. Braun's Streamline Bloodline Set for Dialog+ after an assembly problem could allow a connector to detach or leak during dialysis. The agency listed the early alert in its October 27 updates.

Match the model and lot

  • Model: SL-2010M2096.
  • Lots: A2600099, A2600128 and A2600136.
  • UDI-DI identifiers: 04046964367786 and 04046964367779.

B. Braun's October 20 customer letter, as summarized by the FDA, tells facilities to stop using affected stock, quarantine it and return it to the manufacturer. Distributors should forward the notice to their customers.

The FDA says a required solvent step was missed during assembly, leaving the dialyzer connector inadequately bonded. Detachment or leakage can cause blood loss, clotting or air entering the blood circuit. Severe blood loss can be life-threatening.

B. Braun reported no serious injuries or deaths as of October 10, 2026, according to the alert.

US customers can contact B. Braun at [email protected] or 610-849-1197.

A separate notice has different instructions

The FDA also has a separate instruction-correction notice for the same model, with a different list of lots beginning A25. That notice describes damaged patient connectors and additional precautions when alternative equipment is unavailable.

It says the correction does not involve removing those listed products from use or sale. The new three-lot alert directs removal. Facilities should match the lot to the relevant notice before applying its instructions.

The separate correction is identified by the FDA as its most serious recall type. That classification should not be transferred to the new early alert.

The FDA's early-alert policy explains that these communications can precede a determination that a company's action meets the regulatory definition of a recall. They communicate potentially high-risk removals or corrections while the agency reviews the information.

Patients with questions about the supplies used in their treatment can ask their dialysis team to check the model and lot.