FDA Device recall Z-1859-2021
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney…
- FDA Device
- Class II
- terminated
- Published 2021-06-23
On 2021-06-23 the FDA classified a Class II recall of Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney… by Medivators, citing the lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1859-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-20 |
| Published | 2021-06-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medivators |
| Distribution | US |
Product
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
Reason
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Identifiers
| code_info | Lot 489224 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1859-2021%22
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