The U.S. Food and Drug Administration has issued an urgent notice regarding the updated instructions for the use of the Streamline Bloodline Set for Dialog+ Hemodialysis System manufactured by B Braun Medical Inc. This correction is critical for clinical teams, regulatory professionals, and quality personnel using or overseeing the affected medical devices.
What changed?
The recall, categorized by the FDA as the most serious type, involves revisions to the use instructions for certain blood tubing sets due to a manufacturing issue. While the devices are not being removed from use or sales channels, continued use without adherence to the updated instructions can lead to severe outcomes, including injury or death.
The issue stems from damaged arterial and venous patient connectors in affected product lots. These defects can result in micro-air bubbles, blood or fluid leakage, air embolism risks, and rising infection concerns. Importantly, this alert aims to mitigate these risks through improved procedural adherence rather than product removal.
Who is affected?
The affected Streamline Bloodline Set for the Dialog+ Hemodialysis System includes product model SL-2010M2096. Specific lots impacted are listed in the manufacturer communication. Professionals using or overseeing the impacted sets must adjust their clinical approach to comply with revised instructions and reduce potential harm to patients.
Distributors who have further supplied these sets should immediately notify their consignees and extend the correction notice to all customer levels.
What actions to take?
Follow updated instructions
Users must adhere strictly to the manufacturer’s revised Instructions for Use (IFU) for securing patient connectors. The IFU emphasizes secure luer and locking ring connections to eliminate pathways for air ingress or leakage.
Enhance visual inspections
During dialysis treatment, conduct increased visual inspections of bloodlines to identify air ingress or signs of connector damage. Should issues arise, perform the following:
- If leakage or bubbles are observed, attempt to resecure or tighten connections as per IFU guidelines.
- If problems persist, halt procedures and replace the bloodline at the earliest clinically safe moment.
Mitigate specific risks
To reduce microbubble-related complications, avoid high-flow dialysis if bubbles are present. If alternative dialysis equipment or non-impacted tubing sets are unavailable, additional steps are critical to safeguard patient outcomes and minimize harm.
Manufacturer statement
B Braun Medical Inc. has confirmed that as of September 30, 2025, there have been no reported injuries or fatalities related to this issue. However, any blood loss or exposure to infection renders this correction essential for patient safety, particularly among critically ill individuals.
Conclusion
This alert underscores the importance of adhering to the new use instructions to minimize risks to patient safety when using affected Streamline Bloodline Sets. Clinical teams must remain vigilant, follow procedural steps carefully, and communicate this information throughout their organizations.
Disclaimer
This update is informational and intended for healthcare and regulatory professionals. It does not constitute legal advice or guarantee safety outcomes.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/alert-update-use-instructions-b-braun-hemodialysis-blood-tubing-set