FDA DeviceClass INotable

FDA Recall: B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.

Name: FDA Recall: B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
Brand: B Braun Medical Inc

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

4,884 units

View original recall →

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