Recall Z-0829-2018 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Renal Therapies Group, LLC
2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
| Date | Feb 20, 2018 (initiated Oct 5, 2017) |
| Status | Terminated |
| Reason | While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly. |
| Root cause | Software Design Change |
| Action | Fresenius Medical Care sent an Urgent Medical Device Correction letter dated April 24, 2017 to affected customers. the letter identified the affected product, problem and actions to be taken. For questions contact Technical Services at 1-800-227-2572. |
| Quantity | 15 machines |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080964 | FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America, Jan 14, 2009 |
| K113427 | FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America, Dec 21, 2011 |
| K120017 | FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM Fresenius Medical Care North America, Feb 2, 2012 |
| K120505 | FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America, Design Cente, Mar 6, 2012 |
| K121341 | FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM Fresenius Medical Care North America, Dec 6, 2012 |