This recall involves updating instructions for using certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.

Affected Product

Device Description: Streamline Bloodline Set for Dialog+ 

  • Model: SL-2010M2096
  • UDI-DI: 04046964367786; 04046964367779
  • Impacted Lots: A2500119, A2500121, A2500128, A2500129, A2500130, A2500132, A2500133, A2500134, A2500149, A2500150, A2500151, A2500180, A2500181,  A2500182, A2500185, A2500198, A2500199, A2500200, A2500203, A2500204,  A2500205, A2500206, A2500207, A2500208, A2500209, A2500210, A2500211, A2500212, A2500213, A2500214, A2500215, A2500216, A2500217, A2500218, A2500219, A2500220, A2500246, A2500247, A2500248, A2500249, A2500250, A2500251, A2500257, A2500258, A2500259, A2500260, A2500261, A2500262, A2500267, A2500268, A2500269, A2500273, A2500274, A2500275, A2500276, A2500277, A2500278, A2500295, A2500298, A2500299, A2500300

What to Do

Use non-impacted SL-2010M2096 sets or alternate dialysis equipment and disposables if possible. If alternative equipment is not available and affected product must be used to treat patients, users should take additional actions to mitigate patient harm such as air embolism.

On September 30, B Braun Medical Inc. sent all affected customers a letter recommending the following actions:

  • If alternate equipment is not available, customers should: 
    • Ensure full adherence to the product Instructions for Use (IFU). In particular, the instructions for secure connection of patient connectors should be followed to reduce the probability of air ingress or leakage. See excerpt below.
    • Increase visual inspection of the bloodlines during treatment. If air ingress or leakage is observed, re-secure or tighten connection using the product IFU. See excerpt below.
    • If re-securement or tightening connections does not resolve the concern, stop the procedure, clamp lines, and reposition the patient, and replace bloodline at earliest clinically feasible time.
    • If possible, avoid high flow during treatment if microbubbles are present
  • Ensure all users in your organization of this product and other concerned personnel are informed of this voluntary correction.
  • If you are a distributor and have further distributed the product, please forward the notice to your consignees. The correction is to be extended to the customer level. 
  • EXCERPT FROM INSTRUCTIONS FOR USE (IFU) of Streamline Bloodline Set for Dialog+:
    • When recirculation is complete and patient’s vascular access devices are prepared, attach arterial patient connector to arterial access device as follows:
    • Establish luer connection first before engaging the male locking ring. Holding only the clear back end of the patient connector, firmly push the male luer cone into the female luer socket with no more than a quarter (1/4) turn. This connection must be secure before engaging the locking ring (see below FIRST photo). 
    • Twist on the threaded locking ring of the patient connector until it is finger-tight and secure with the access device’s female port (see below SECOND photo).

Reason for Alert

BBMI has identified a manufacturing issue where the arterial and venous patient connectors of certain lots of Streamline Bloodline Set for Dialog+ were damaged which may result in micro-air bubbles in the line and trigger air-in-line alarms. This damage creates a pathway for air to enter the extracorporeal circuit and the potential for blood/fluid leakage.

The detection of micro-air bubbles in the line during patient use may require set replacement, resulting in treatment delays. If the operator is unable to change the bloodlines and determines that continued treatment is appropriate, it may result in inadequate or inefficient treatment. 

In cases where air is pulled into the line, blood in the extracorporeal circuit cannot be returned to the patient and must be discarded, leading to moderate patient blood loss. In some instances, this blood loss may cause a significant change in patient condition requiring immediate treatment. An opening in the bloodline results in a loss of sterility, potentially leading to bloodstream infections that require medical intervention. In some patients, including critically ill patients, blood loss or potential infection may lead to life-threatening adverse events, including death. Additional risks include air entering the patient circulation which may lead to air embolism.

As of September 30, 2025, BBMI has received no reports of 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 use with a medically prescribed hemodialyzer.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact BBMI’s Postmarket Surveillance Department at 1-833-425-1464.

Additional FDA Resources

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 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.