FDA DeviceClass INotable

FDA Recall: B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095

Date: 2026-04-22

Brand: B Braun Medical Inc

Category: Medical Device

FDA Class: Class I

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.

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.

Remedy

328,640 units

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