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.
Affected Product
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+
- Model: SL-2010M2096
- UDI-DI: 04046964367786; 04046964367779
- Impacted Lots: A2600099, A2600128, A2600136
What to Do
Ensure all users are informed of the recall. Identify and quarantine all affected devices.
On October 20, 2026, B. Braun sent all affected customers a letter recommending the following actions:
- Ensure all users in your organization and other concerned persons are informed about this recall.
- If you are a distributor, please forward this notice to your consignees.
- Determine inventory of the affected items, cease use and quarantine product subject to recall. Return affected product to the manufacturer.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
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.
If the arterial tubing detaches, partially separates, or leaks during dialysis treatment, blood may be lost from the extracorporeal circuit, and the treatment may need to be interrupted while the bloodline is replaced. In some cases, blood loss may also occur due to clotting and occlusion of the bloodline, requiring replacement of the extracorporeal circuit. Hemodialysis patients are medically fragile, and extracorporeal blood loss may require clinical assessment, corrective treatment, professional medical intervention, or hospitalization. In severe cases, significant blood loss could be life-threatening.
Inadequate bonding may also result in leakage or partial separation of the arterial tubing connection, permitting air entry into the blood circuit. Air entering the blood circuit is expected to be detected by the dialysis machine’s air detection system and managed by healthcare personnel; however, treatment interruption, bloodline replacement, additional patient assessment and monitoring, and medical intervention may be required. In extremely rare circumstances, air that passes the dialysis machine air detection system could result in air embolism and death.
As of October 10, 2026, B. Braun has reported no serious injuries or deaths associated with this issue.
Device Use
The Streamline Bloodline Set for Dialog+ Hemodialysis System is a blood tubing set indicated for hemodialysis.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact B. Braun at [email protected] or (610) 849-1197.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Article source: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-b-braun-removes-streamline-bloodline-set-dialog