Recall Z-1803-2026 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
B Braun Medical Inc
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
| Date | Apr 15, 2026 (initiated Mar 19, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | B. Braun notified consignees on about 03/19/2026 via letter titled URGENT MEDICAL DEVICE CORRECTION. Consignees were instructed to use alternative dialysis equipment and disposables, if possible. If not, BBMI recommends the following actions that can help mitigate potential harm should you need to use sets impacted by this field action on patients: 1. Ensure full adherence to both the bloodline and dialysis machine Instructions for Use (IFU). a. Streamline bloodlines - strict adherence to the priming process as outlined in the IFU, with special emphasis on Step 26. b. B3 bloodlines - strict |
| Quantity | 4,884 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080807 | BLOOD TUBING SETS (STERILE FLUID PATH) Nxstage Medical, Inc., Jul 18, 2008 |