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Early Alert: B. Braun Removes Streamline Bloodline Set for Dialog+
The FDA is aware that B. Braun has issued a letter to affected customers recommending certain Hemodialysis Bloodlines be removed from where they are used or sold. Affected devices:
- Product Description: Streamline Bloodline Set for Dialog+
- UDI-DI: 04046964367786; 04046964367779
- Impacted Lots: A2600099, A2600128, A2600136
B. Braun stated that the required solvent application step during assembly was not performed, resulting in inadequate bonding of the dialyzer connector. As a result, the bloodline connector may detach or leak during priming or dialysis treatment, potentially leading to blood loss, clotting and occlusion of the extracorporeal circuit, and/or air ingress into the blood circuit.
As of October 10, 2026, B. Braun has reported no serious injuries or deaths associated with this issue.
Questions?
Customers in the U.S. with questions about this recall should contact B. Braun at recalls@bbraunusa.com or (610) 849-1197.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
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