FDA Device recall Z-1858-2014
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 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-305 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-1858-2014 |
| 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-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40
Reason
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Identifiers
| code_info | Lot codes: 40179026 3057901 3047930 |
|---|
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-1858-2014%22
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