Recall Z-2702-2026 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 3. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 4. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.
| Date | Jul 8, 2026 (initiated May 11, 2026) |
| Status | Open, Classified |
| Reason | Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. |
| Root cause | Process control |
| Action | Fresenius Medical Care notified consignees on about 05/11/2026 via "IMPORTANT MEDICAL DEVICE INFORMATION" letter. Consignees were informed of the issue of potential Online Port Errors and additional information to support proper connection of the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. When pushing the substitution fluid connector (SafeLineTM) into the substitution fluid port, firmly insert the substitution fluid connector until you feel resistance. Check that there is no visible gap between the ring of the connector and the module. In the case o |
| Quantity | 113,544 units (4,731 cases) |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, PA, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243505 | 5008X Hemodialysis System Fresenius Medical Care Renal Therapies Group, LLC, May 30, 2025 |