Official recall notice

FDA DeviceClass INotable

FDA Recall: B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.

Recall date
2026-04-22
FDA class
Class I

Why it was recalled

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.

Recommended action

What to do

1,174,271 units

Product description

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

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