Dialysate Concentrate for Hemodialysis-Liquid/Powd — Class II medical device recall Z-1859-2021
Terminated recall by Medivators, Inc., reported 2021-06-23, distributed nationwide. The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specifi
| Recall number | Z-1859-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medivators, Inc., Plymouth, MN, United States |
| Recall initiated | 2021-04-20 |
| Classified | 2021-06-15 |
| Reported by FDA | 2021-06-23 |
| Terminated | 2024-07-11 |
| Distributed | Nationwide (US) |
| Quantity | 1,381 cases |
| Reason classes | specification failure |
| Lot numbers | 489224 |
Product
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
Reason for recall
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
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-1859-2021. 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.