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 SL-2000M2095L) distributed nationwide in the US and Canada because small air bubbles can accumulate in the arterial line when blood gases stick to the tubing under negative pressure. This is a Class II recall affecting the StreamLine Bloodline Long Version and related B. Braun hemodialysis bloodlines used in kidney dialysis treatment.
- Recalling firm
- B Braun Medical Inc
- Product
- B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
- 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/107bd90c-de94-480c-a0e5-6f6223c3c571