CLASS II Device recall · Reported 25 Dec 2019 · FDA Enforcement Report

Low Volume Cartridge IFU recalled by NxStage Medical

NxStage Medical is recalling Low Volume Cartridge IFU (, distributed in Alabama, Arizona, California, North Carolina, Virginia. The recall was initiated on 27 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct 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

Quantity recalled1803 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0697-2020
FDA event ID: 83706
Recalling firm: NxStage Medical, Lawrence, MA
Classification: Class II
Status: Terminated
Recall initiated: 27 Aug 2019
FDA classified: 18 Dec 2019
Reported: 25 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Aug 2019	Recall initiated by company
18 Dec 2019	Classified by FDA	+113 days
25 Dec 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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;

Where it was distributed

AL, AZ, CA, NC & VA

Alabama Arizona California North Carolina Virginia

Questions about this recall

Is Low Volume Cartridge IFU ( recalled?

Yes. NxStage Medical recalled Low Volume Cartridge IFU ( on 27 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-0697-2020.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

AL, AZ, CA, NC & VA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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