B Braun Medical Inc: B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- B Braun Medical Inc
- Product
- B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
- Reason / 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.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall initiated
- 2026-03-19
- Code info
- Model Number: SL-2000M2095DA; UDI-DI Primary: 04046955776023; UDI-DI Unit: 04046955776016; All lots manufactured since 09JUN2025.
- Product quantity
- 1,174,271 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bethlehem
- State
- PA
- Country
- United States
- Event id
- 98552
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