NxStage Dialysate Sack — Class II medical device recall Z-1858-2014
Terminated recall by NxStage Medical, Inc., reported 2014-07-02, distributed nationwide. SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
| Recall number | Z-1858-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NxStage Medical, Inc., Lawrence, MA, United States |
| Recall initiated | 2014-05-14 |
| Classified | 2014-06-24 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2017-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | ES, FR, GB, NL, SE |
| Quantity | 2,839 cases |
| Lot numbers | 3047930, 3057901, 40179026 |
| Model numbers | SAK-305 |
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 for recall
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1858-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.