FDA recall Z-1803-2026

B Braun Medical Inc · Class I · device

Product

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

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2026-03-19
Report date
2026-04-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bethlehem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1803-2026