FDA Device recall Z-1803-2026
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705
- FDA Device
- Class I
- ongoing
- Published 2026-04-22
On 2026-04-22 the FDA classified a Class I recall of B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705 by B Braun Medical, citing potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1803-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-03-19 |
| Published | 2026-04-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
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.
Identifiers
| code_info | Model Number: B3-4630M4705; UDI-DI Primary: 04046955348848; UDI-DI Unit: 04046955348831; All lots manufactured since 05AUG2025. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1803-2026%22
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