FDA Device recall Z-1856-2014
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesi…
- FDA Device
- Class II
- terminated
- Published 2014-07-02
On 2014-07-02 the FDA classified a Class II recall of NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesi… by Nxstage Medical, citing SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1856-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-14 |
| Published | 2014-07-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nxstage Medical |
| Distribution | US |
Product
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m Chloride 100m, 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.
Reason
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Identifiers
| code_info | Lot codes: 40179030 3067904 3067902 3057925 3057924 3047934 3047929 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2025-06-04 · Nxstage Medical - NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-4…
FDA Device · Class II · 2024-06-26 · Nxstage Medical - Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1
FDA Device · Class II · 2019-12-25 · Nxstage Medical - NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement thera…
FDA Device · Class II · 2019-06-12 · Nxstage Medical - NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy syste…
FDA Device · Class II · 2019-06-12 · Nxstage Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1856-2014%22
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