B Braun Medical Inc: Set, Tubing, Blood, With And Without Anti-regurgitation Valve
Recall Summary B. Braun Medical Inc is recalling certain hemodialysis bloodline sets (model B3-3632M3705) distributed nationwide in the US and Canada because small air bubbles can accumulate in the arterial line when negative pressure causes blood gases to stick to the tubing. This is a Class II recall, meaning the product could cause serious health problems but is unlikely to cause death.
- Recalling firm
- B Braun Medical Inc
- Product
- B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
- Reason
- Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-19
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/547ae521-6701-4d76-9666-047eabb7dad1