B. Braun Hemodialysis Blood Tubing Set Recall - Air Bubble Risk

Health Canada has issued a Type II medical device recall (Identification No. RA-81821) for B. Braun Hemodialysis Blood Tubing Sets manufactured by B. Braun Medical Inc. The recall addresses the potential for accumulation of small air bubbles in the arterial line due to blood gases adhering to the tubing under negative pressure conditions. Affected products include model numbers B3-4630M4705 and B3-3632M3705 across all lots.

Healthcare providers should immediately identify any B. Braun Hemodialysis Blood Tubing Sets in their inventory matching these model numbers, remove affected products from clinical use, and contact B. Braun Medical Inc. directly for return/replacement procedures. Any adverse events potentially associated with this device issue should be reported to Health Canada. No specific compliance deadline was provided; however, given the Type II classification indicating potential temporary harm, prompt action is warranted.