Lawrence, MA, US · 3 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Class II | Gastroenterology, Urology | 2 | 2024-03-14 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | Class II | Gastroenterology, Urology | 1 | 2024-01-18 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-04-28 | Class II | Ongoing | Z-1864-2025 | NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RF… | — | Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when atte… |
| 2024-05-14 | Class II | Ongoing | Z-2160-2024 | NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-… | — | The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamb… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-03-14 | K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | KDI | Class II | Gastroenterology, Urology |
| 2024-01-18 | K233213 | NxStage PureFlow Solution | KPO | Class II | Gastroenterology, Urology |
| 2023-08-11 | K230632 | VersiHD with GuideMe software | KDI | Class II | Gastroenterology, Urology |