B. Braun StreamLine bloodlines recalled for potential air bubbles
B. Braun Medical Inc is recalling certain hemodialysis bloodlines (model SL-2000M2095L) because small air bubbles can collect in the arterial line when the tubing is under negative pressure. This happens because blood gases stick to the inside of the tubing. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All B. Braun recalls
What to do
- Stop using affected bloodline units immediately if you have them.
- Contact your hemodialysis center or B. Braun Medical Inc to confirm if your equipment is affected.
- Do not use model SL-2000M2095L manufactured on or after June 29, 2025.
- Return or dispose of recalled units as instructed by your provider or manufacturer.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 6 products — see all of them.
Details
- Units affected
- 328,640 units
- Illnesses reported
- None reported
- Manufactured in
- 824 12th Ave, N/A, Bethlehem, PA, United States
- Classification
- Class I
- Recall number
- Z-1801-2026
In the FDA's words
- Description
- B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. Model Number: SL-2000M2095L; UDI-DI Primary: 04046955348909; UDI-DI Unit: 04046955348893; All lots manufactured since 29JUN2025. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Affected quantity: 328,640 units
- Hazard
- Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
6 products in this recall
B. Braun hemodialysis bloodlines recalled for air bubble risk
B. Braun is recalling six hemodialysis bloodline tubing sets used during kidney dialysis. Air bubbles can build up in the arterial line because blood gases can stick to the tubing under negative pressure. No injuries have been reported, and the products were distributed across the US and Canada.
The agency lists each product separately. Check every one you might have.
- B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.Z-1798-2026 · 3,158,104 units
- B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096Z-1799-2026 · 2,653,711 units
- B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.Z-1800-2026 · 1,174,271 units
- B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L. (this page)Z-1801-2026 · 328,640 units
- B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.Z-1802-2026 · 4,848 units
- B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.Z-1803-2026 · 4,884 units
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