NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010 — Class II medical device recall Z-0811-2018
Terminated recall by NxStage Medical, Inc., reported 2018-03-07, distributed nationwide. May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid
| Recall number | Z-0811-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NxStage Medical, Inc., Lawrence, MA, United States |
| Recall initiated | 2018-01-29 |
| Classified | 2018-03-01 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2020-04-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | ES, GB |
| Reason classes | sterility |
| Lot numbers | 70779202, 70779236, 70879045, 70879105, 70879181, 70879187, 70879220, 70879224, 70879233, 70879235, 70879236, 70879245, 70979066, 70979110, 70979253, 71079056, 71079144, SAK-302, SAK-303, SAK-304, SAK-306, SAK-307, SAK-402, SAK-405, SAK-406, SAK-407 |
| Model numbers | AK-301, AK-302, AK-303, AK-304, AK-306, AK-307, AK-402, AK-405, AK-406, AK-407 |
| Expiration dates | 2019-07-08, 2019-07-09, 2019-07-11, 2019-07-24, 2019-07-29, 2019-07-30, 2019-08-27 |
Product
NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070 Hemodialysis systems and accessories
Reason for recall
May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product.
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-0811-2018. 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.