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
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-1859-2014
- 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-306 Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1, Chloride 101, 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.
Questions about this recall
Is NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL recalled?
Yes. NxStage Medical recalled NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL on 14 May 2014. The recall is Class II and its status is Terminated. Recall number Z-1859-2014.
Why was it recalled?
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Which lots are affected?
Lot codes: 31279092 3047917 3047916
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 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.
More recalls from NxStage Medical
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NxStage PureFlow-B Solution recalled by NxStage Medical | NxStage Medical | Packaging Defects | Nationwide |
| Device | CLASS II | NxStage PureFlow-B Solution, Premixed Dialysate recalled | NxStage Medical | Other | Nationwide |
| Device | CLASS II | Low Volume Cartridge IFU recalled by NxStage Medical | NxStage Medical | Other | 5 states |
| Device | CLASS II | NxStage PureFlow B Solution recalled by NxStage Medical | NxStage Medical | Labeling Errors | Nationwide |
| Device | CLASS II | NxStage PureFlow B Solution recalled by NxStage Medical | NxStage Medical | Labeling Errors | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |