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FDA-Device2026-04-22Class IPROCESSING DEFECT

B Braun hemodialysis bloodlines recalled for potential air bubble accumulation in arterial line

B. Braun
OTHERNationwide distribution

Stop using B Braun hemodialysis bloodlines Model B3-4630M4705

B Braun Medical Inc is recalling specific hemodialysis bloodline tubing (Model B3-4630M4705) because small air bubbles can accumulate in the arterial line when blood gases stick to the tubing under negative pressure. This could affect dialysis treatment safety. The recall affects units manufactured since August 5, 2025.

  • Stop using hemodialysis bloodlines Model B3-4630M4705 immediately
  • Check your dialysis supplies for the recalled model number on the packaging
  • Contact your dialysis center or B Braun Medical Inc if you have this product
  • Do not use recalled bloodlines for any dialysis treatment
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.

Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
4,884 units
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Products
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.

Official notice

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

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