—#219065

Product

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

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 Number SL-2010M2096A; UDI-DI Primary: 04046955674992; UDI-DI Unit: 04046955735280; All lots manufactured since 09JUN2025

Why it was recalled

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Root cause (FDA determination)

Device Design

Action the firm took

B. Braun notified consignees on about 03/19/2026 via letter titled URGENT MEDICAL DEVICE CORRECTION. Consignees were instructed to use alternative dialysis equipment and disposables, if possible. If not, BBMI recommends the following actions that can help mitigate potential harm should you need to use sets impacted by this field action on patients: 1. Ensure full adherence to both the bloodline and dialysis machine Instructions for Use (IFU). a. Streamline bloodlines - strict adherence to the priming process as outlined in the IFU, with special emphasis on Step 26. b. B3 bloodlines - strict adherence to the priming process as outlined in the IFU, with special emphasis on Step 12. 2. If possible, avoid high flow during treatment if small air bubbles are present. 3. Avoid retrograde rinseback if small air bubbles are present. 4. Be alert for a follow-up communication indicating the issue is resolved. Consignees were also instructed to review the customer notification its entirety, ensure all affected personnel are notified and aware of the issue, post the notification where the affected products are stored, and complete and return the response form. For distributors, they were instructed to forward the notification to all consignees as this recall extends to the consumer level. B. Braun will provide a follow up communication to users when lots with corrective actions are available, and users may resume high flow treatment and use of retrograde rinseback where indicated.

Recalling firm

Firm: B Braun Medical Inc
Address: 824 12th Ave, Bethlehem, Pennsylvania 18018-3524

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Timeline

Recall initiated: 2026-03-19
Posted by FDA: 2026-04-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #219065. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.