FDA Early Alert: B. Braun Removes Three Lots of Streamline Bloodline Sets for Dialog+ Over Connector Bonding Failure
The U.S. Food and Drug Administration (FDA) issued an Early Alert on October 27, 2026, saying B. Braun has recommended that certain Streamline Bloodline Sets for Dialog+ be removed from where they are used or sold: model SL-2010M2096, lots A2600099, A2600128 and A2600136. The FDA said a required solvent application step during assembly was not performed, resulting in inadequate bonding of the dialyzer connector, which may detach or leak during priming or dialysis treatment. The agency called it a potentially high-risk device issue; as of October 10, B. Braun had reported no serious injuries or deaths associated with the issue.
The bloodline set is a blood tubing set indicated for hemodialysis with the Dialog+ system. According to the FDA, if the arterial tubing detaches, partially separates or leaks during treatment, blood may be lost from the extracorporeal circuit and treatment may need to be interrupted while the bloodline is replaced; blood loss may also occur due to clotting and occlusion of the bloodline. Hemodialysis patients are medically fragile, and extracorporeal blood loss may require clinical assessment, corrective treatment, professional medical intervention or hospitalization, and in severe cases significant blood loss could be life-threatening. Inadequate bonding may also permit air entry into the blood circuit; the air is expected to be detected by the dialysis machine's air detection system and managed by healthcare personnel, but in extremely rare circumstances air passing the detection system could result in air embolism and death.
On October 20, 2026, B. Braun sent a letter to all affected customers recommending that all users be informed of the recall, that distributors forward the notice to their consignees, and that customers determine their inventory, cease use, quarantine the affected product and return it to the manufacturer. The FDA said it is currently reviewing information about the issue and will update the alert page as significant new information becomes available.
Customers in the United States with adverse reactions, quality problems or questions should contact B. Braun at [email protected] or (610) 849-1197. Health care professionals and consumers may also report problems to MedWatch, the FDA Safety Information and Adverse Event Reporting Program. The affected devices carry UDI-DI numbers 04046964367786 and 04046964367779.
Source: GSM · USA (original Chinese edition)
Photo: 血液透析机（资料图）。Jackhsiao 摄，公共领域，经 Wikimedia Commons。 / A hemodialysis machine (file photo). Photo by Jackhsiao, public domain, via Wikimedia Commons.
