CLASS II Device recall · Reported 2 Jul 2014 · FDA Enforcement Report

NxStage Dialysate Sack (SAK) with Concentrate for Use recalled

NxStage Medical is recalling NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL, distributed nationwide in the US. The recall was initiated on 14 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot code: 40179126 40179125 40179108 40179036 40179035 31279119 3057923 3057907 3047927

Quantity recalled8683 cases

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-1860-2014
FDA event ID: 68354
Recalling firm: NxStage Medical, Lawrence, MA
Classification: Class II
Status: Terminated
Recall initiated: 14 May 2014
FDA classified: 24 Jun 2014
Reported: 2 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Insulin Pumps & Glucose Monitors

Timeline

14 May 2014	Recall initiated by company
24 Jun 2014	Classified by FDA	+41 days
2 Jul 2014	Published in enforcement report	+8 days

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

Reason for recall

SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.

Nationwide

Questions about this recall

Why was it recalled?

SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Which lots are affected?

Lot code: 40179126 40179125 40179108 40179036 40179035 31279119 3057923 3057907 3047927

Where was it sold?

Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.

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

Other products in this recall event

7 other products · FDA event 68354

This product is part of a recall event; the main page for the event is NxStage Dialysate Sack (SAK) with Concentrate for Use recalled.

Reported	Class	Recall	Company	Reason	Where
2 Jul 2014	CLASS II	NxStage Dialysate Sack (SAK) with Concentrate for Use recalled	NxStage Medical	Packaging Defects	Nationwide
2 Jul 2014	CLASS II	NxStage Dialysate Sack (SAK) with Concentrate for Use recalled	NxStage Medical	Other	Nationwide
2 Jul 2014	CLASS II	NxStage Dialysate Sack (SAK) with Concentrate for Use recalled	NxStage Medical	Packaging Defects	Nationwide
2 Jul 2014	CLASS II	NxStage Dialysate Sack (SAK) with Concentrate for Use recalled	NxStage Medical	Packaging Defects	Nationwide
2 Jul 2014	CLASS II	NxStage Dialysate Sack (SAK) with Concentrate for Use recalled	NxStage Medical	Packaging Defects	Nationwide
2 Jul 2014	CLASS II	NxStage Dialysate Sack (SAK) with Concentrate for Use recalled	NxStage Medical	Other	Nationwide
2 Jul 2014	CLASS II	NxStage Dialysate Sack (SAK) with Concentrate for Use recalled	NxStage Medical	Packaging Defects	Nationwide

More recalls from NxStage Medical

All 31

Reported	Class	Recall	Company	Reason	Where
4 Jun 2025Device	CLASS II	NxStage PureFlow-B Solution recalled by NxStage Medical	NxStage Medical	Packaging Defects	Nationwide
26 Jun 2024Device	CLASS II	NxStage PureFlow-B Solution, Premixed Dialysate recalled	NxStage Medical	Other	Nationwide
25 Dec 2019Device	CLASS II	Low Volume Cartridge IFU recalled by NxStage Medical	NxStage Medical	Other	5 states
12 Jun 2019Device	CLASS II	NxStage PureFlow B Solution recalled by NxStage Medical	NxStage Medical	Labeling Errors	Nationwide
12 Jun 2019Device	CLASS II	NxStage PureFlow B Solution recalled by NxStage Medical	NxStage Medical	Labeling Errors	Nationwide

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26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
15 Jul 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Device Malfunction	CA
8 Jul 2026Device	CLASS I	Omnipod (Eros) Pod recalled by Insulet	Insulet	Packaging Defects	Nationwide