Z-0697-2020Class II

Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2)...

Name: Z-0697-2020 Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2)...
Creator: NxStage Medical, Inc.
Published: 2019-08-27
License: https://open.fda.gov/license/

NxStage Medical Inc / initiated 2019-08-27 / Terminated

FDA source

NxStage Medical, Inc. began a recall of 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... on 2019-08-27. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0697-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-27
Posted: 2019-12-18
Terminated: 2021-02-01
Recalling firm: NxStage Medical Inc
Product: 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;
Product code: PEV Dialysis Administration Kit
Reason for recall: 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.
FDA 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 System One S or NxStage VersiHD Cycler, model NX1000-3, NX1000-3A, NX1000-10, NX1000-10A, NX1000-16, or NX1000-16A: - At dialysate flow rates of 3.0 Liters/hour and below, the system may have a fluid removal error defined as the greater of up to 25 ml/hour or 5% of Total Ultrafiltration Volume. The Total Allowable Error is dependent on the error rate and length of treatment and can continue to increase for as long as treatment is being delivered. - At dialysate flow rates of above 3.0 Liters/hour, the system may have a fluid removal error defined as the greater of up to 100 ml/hour or 5% of Total Ultrafiltration Volume. The Total Allowable Error is dependent on the error rate and length of treatment and can continue to increase for as long as treatment is being delivered. NxStage discourages the use of the System for the treatment of low blood volume patients. If the physician considers it appropriate to prescribe home hemodialysis using the NxStage System One for low blood volume patients, the following points should be considered: 1. When performing hemodialysis treatments for low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) patients, NxStage strongly recommends employment of additional monitoring vigilance. Always ensure that cardiac status and fluid status are monitored for low blood volume patients by monitoring bloo
Quantity in commerce: 1803 units
Distribution: AL, AZ, CA, NC & VA
Product codes and lots: Product 1) UDI # - M535NX100010 Product 2) UDI # - M535NX1000160 and M535NX100016A0 Product 3) UDI # - M535NX100030 and M535NX10003A0 Product 4) UDI # - M535NX1000100 and M535NX100010A0 Lot Numbers: 60677021, 60877053, 70477033, 71177020, 80377002, 80477018, 80877011, 81077018, 81177047, 90277048 and 90677002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0697-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0697-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-18

Product code PEV

K050525Class IINxstage System OneNxstage Medical, Inc. / cleared 2005-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)