Early Alert: Bloodline Set for Hemodialysis Systems Issue from B. Braun Medical Inc.
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 Medical Inc. has issued an Urgent Medical Device Correction to affected customers recommending certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines only be used if no alternative is available.
Affected devices:
Material | Description | Unique Device Identifier - Primary | Unique Device Identifier - Unit |
|---|---|---|---|
B3-3632M3705 | LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT | 04046955348817 | |
B3-4630M4705 | LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT | 04046955348831 | |
SL-2000M2095DA | STREAMLINE FRESENIUS FOR DAVITA | 04046955776016 | |
SL-2000M2095L | STREAMLINE BLOODLINE LONG VERSION, FMC | 04046955348893 | |
SL-2010M2096 | STREAMLINE BLOODLINE SET FOR DIALOG | 04046964367779 | |
SL-2010M2096A | STREAMLINE BLOODLINE SET FOR DIALOG DR | 04046955735280 |
What to Do
Use alternate dialysis equipment. If you do not have access to alternate equipment and need to administer treatment, follow the instructions below to help mitigate potential harm.
On March 19, B. Braun Medical Inc. sent all affected customers a letter recommending the following actions:
- Ensure full adherence to both the bloodline and dialysis machine Instructions for Use
- Avoid high flow during treatment if small air bubbles are present
- Avoid retrograde rinseback if small air bubbles are present
- Ensure all users and relevant personnel are informed of this correction
- Post the Urgent Medical Device Correction notice where the affected products are stored
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 Medical Inc. has preliminary testing showing that a change to the tubing resin has led to small air bubbles adhering to the inside of the arterial bloodline, in the segment between the patient connector and the blood pump. These bubbles are the result of degassing of blood on the arterial side of the blood pump due to the negative pressure within the tubing and are not being drawn into the bloodline from the external environment. With the previous tubing resin, these bubbles remained in the blood and were compressed or dissolved via the positive pressure applied post blood pump. With the new resin, these small bubbles adhere to the inside of the bloodline and may gather to form larger bubbles. This process of degassing and bubble formation normally begins approximately 60 minutes into dialysis treatment.
Air bubbles detected in the line during use may lead to a delay in treatment to replace the set and resume therapy. If the operator does not replace the set, it may result in less efficient treatment. If the safety air detector in the dialysis machine detects the bubbles, the machine will alarm and automatically stop treatment. The operator must respond to the alarm to continue treatment, which may include replacing the set and/or monitoring treatment.
Patients may experience moderate blood loss if it is not clinically feasible to return the blood in the extracorporeal circuit to the patient. In some patients, blood loss may lead to life-threatening adverse events, including death.
As March 20, 2026, B. Braun Medical Inc. has not reported any serious injuries or deaths associated with this issue.
Device Use
Bloodline tubing sets are a collection of tubing segments and associated devices like connectors and clamps that are intended to transfer blood between a patient’s vascular access device and a hemodialyzer during hemodialysis.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact B. Braun Medical Inc. at Recalls@bbraunusa.com or 1-833-425-1464.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
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.