Recall Z-0697-2020 ยท PEV Dialysis Administration Kit
NxStage Medical, Inc.
Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10 and NX1000-10-A;
| Date | Aug 27, 2019 |
| Status | Terminated |
| Reason | There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) when prescribing larger dialysate volumes. |
| Root cause | Under Investigation by firm |
| Action | On August 27, 2019, NxStage issued URGENT MEDICAL DEVICE CORRECTION notices to customers. Actions to be Taken by Customers: For patients using NxStage System One Cycler, model NX1000-1: - At any dialysate flow rate, the system may have a fluid removal error defined as the greater of 3% of Total Dialysate Volume or 300 ml/12hr. The Total Allowable Error is generally dependent on total dialysate volume processed for this System model. For patients using less than 10L of dialysate per treatment, this model has a minimum Total Allowable Error volume of 300 ml. For patients using NxStage Sys |
| Quantity | 1803 units |
| Distribution | AL, AZ, CA, NC & VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050525 | NXSTAGE SYSTEM ONE Nxstage Medical, Inc., Jun 24, 2005 |