—#216104

Product

Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A

FDA product code: FJK — Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K080807
Affected lot / code info: Model No. SL-2010M2096; UDI-DI 04046964367786; Lot Numbers: 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; ***Addded 3/24/2026***Additional Lots Identified A2500318, A2500319, A2500320, A2500321, A2500322, A2500323, A2500324, A2500325, A2500326, A2500327, A2500328, A2500329, A2500330, A2500356, A2500357;

Why it was recalled

The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.

Root cause (FDA determination)

Process control

Action the firm took

On September 29, 2025, "URGENT MEDICAL DEVICE CORRECTION" letters dated September 24, 2025, were sent to customers. Actions to be taken: 1. 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. 2. Increase visual inspection of the bloodlines during treatment. If air ingress or leakage is observed, re-secure or tighten connection using the product IFU. In some instances, the dialysis treatment should be stopped. 3. If re-securement or tightening connections does not resolve the concern, replace bloodline at earliest clinically feasible time. 4. If possible, avoid high flow during treatment if microbubbles are present. B. Braun Medical Inc. (BBMI) Customer/User: 1. Review this notice in its entirety. Ensure that all users in your organization of the above-mentioned products, and other concerned personnel are informed about this voluntary correction. Post this notification where the affected products are stored. Note: Product is not being returned as part of this correction notification. a. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The correction is to be extended to the consumer level. 2. Return the completed Urgent Medical Device Correction Acknowledgement Form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to recalls@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). If you have any questions, contact Director, Corporate Communications at 484-240-8373. ****Update 03/24/2026****On March 5, 2026, URGENT MEDICAL DEVICE CORRECTION letters were sent update letters out to notify of additional 15 lots impacted by the recall.

Recalling firm

Firm: B BRAUN MEDICAL INC
Address: 861 Marcon Blvd, Allentown, Pennsylvania 18109-9577

Distribution

Distribution pattern: Domestic: US Nationwide Distribution.

Timeline

Recall initiated: 2025-09-30
Posted by FDA: 2025-10-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216104. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.