B. Braun Hemodialysis Blood Tubing Set Recall - Air Bubble Risk
Summary
Health Canada issued a Type II recall for B. Braun Hemodialysis Blood Tubing Sets (models B3-4630M4705 and B3-3632M3705) due to potential accumulation of small air bubbles in the arterial line caused by adherence of blood gases to tubing under negative pressure. All lots are affected. Healthcare providers should immediately identify and remove affected products from use and contact the manufacturer for return or replacement instructions.
What changed
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.
What to do next
- Identify all B. Braun Hemodialysis Blood Tubing Sets (model numbers B3-4630M4705 and B3-3632M3705) in inventory
- Remove affected products from clinical use immediately
- Contact B. Braun Medical Inc. to arrange for return or replacement of affected devices
Source document (simplified)
Health product recall
B. Braun Hemodialysis Blood Tubing Set
Brand(s)
Last updated
2026-04-01
Summary
Product B. Braun Hemodialysis Blood Tubing Set Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.
Audience Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| Hemodialysis Blood Tubing Set | All lots. | B3-4630M4705 |
| Hemodialysis Blood Tubing Set | All lots. | B3-3632M3705 |
Issue
The potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Additional information
Details
Original published date:
2026-04-01
Alert / recall type Health product recall Category Health products - Medical devices - Cardiovascular Companies B. Braun Medical Inc.
824 12th Avenue, Bethlehem, Pennsylvania, United States, 18018
Published by Health Canada Audience Healthcare Recall class Type II Recall date
2026-03-20
Identification number RA-81821
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