Recall Z-0035-2024 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
| Date | Oct 6, 2023 (initiated Sep 6, 2023) |
| Status | Open, Classified |
| Reason | Potential PCBA leaching from tubing of hemodialysis machines. |
| Root cause | Device Design |
| Action | Consignees were sent an URGENT MEDICAL DEVICE CORRECTION NOTICE via USPS, dated 09/06/2023. The notice informed consignees that there is a potential for NDL-PCBAs could leach from silicone tubing manufactured with a peroxide-based catalyst. The firm also states that it has been demonstrated that dialysate run through 2008 Series machines used during typical maintenance HD treatments for at least 36 days, cumulatively, showed levels of NDL-PCBAs that were below toxicologically relevant thresholds. Consignees are to contact FMCRTG Technical Service at 1-800-227-2572 to schedule an update to devi |
| Quantity | 733 units |
| Distribution | Domestic: Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC, Dec 10, 2015 |
| K173972 | 2008T BlueStar Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC, May 10, 2018 |
| K222952 | 2008T BlueStar Hemodailysis Machine Fresenius Medical Care Renal Therapies Group, LLC, Oct 27, 2022 |