FDA Device recall Z-1855-2014
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magne…
- 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-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magne… 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-1855-2014 |
| 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-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100, Batch Size (liters): 60 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: 40179127 40179107 40179109 40179105 40179093 40179034 31279120 31279118 3057921 3057920…Lot codes: 40179127 40179107 40179109 40179105 40179093 40179034 31279120 31279118 3057921 3057920 3057915 3057914 3057906 3057905 3047924 3047923 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1855-2014%22
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