Recall Z-0070-2026 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
B BRAUN MEDICAL INC
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A
| Date | Oct 22, 2025 (initiated Sep 30, 2025) |
| Status | Open, Classified |
| Reason | The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors. |
| Root cause | Process control |
| Action | On September 29, 2025, "URGENT MEDICAL DEVICE CORRECTION" letters dated September 24, 2025, were sent to customers. Actions to be taken: 1. Ensure full adherence to the product Instructions for Use (IFU). In particular, the instructions for secure connection of patient connectors should be followed to reduce the probability of air ingress or leakage. 2. Increase visual inspection of the bloodlines during treatment. If air ingress or leakage is observed, re-secure or tighten connection using the product IFU. In some instances, the dialysis treatment should be stopped. 3. If re-securement or t |
| Quantity | 1298454 units (1589674 - 3/5/26 Expansion) |
| Distribution | Domestic: US Nationwide Distribution. |
| 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 |