Recall Z-3017-2026 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
| Date | Aug 26, 2026 (initiated Jun 30, 2026) |
| Status | Open, Classified |
| Reason | Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T BlueStar Hemodialysis machines. |
| Root cause | Process control |
| Action | Fresenius Medical Care issued an URGENT MEDICAL DEVICDE CORRECTION notice to its consignees on 7/15/2026 via USPS First Class Mail. The notice explained the issue, potential risk and requested the following: "What to do at this time: 1. If your affected 2008T BlueStar machine is in use, and you are not experiencing error messages, you may continue to use it until the parts are replaced. 2. If your affected 2008T BlueStar machine experiences flow-, no water-, or temperature-related alarms, please use a back-up machine until FMCRTG can replace the parts in the affected machine. 3. If yo |
| Quantity | 1140 systems |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128 Fresenius Medical Care Renal Therapies Group, LLC, Jun 13, 2025 |