Class II — Rockwell Medical, Inc
| Recalling firm | Rockwell Medical |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch. |
| Product | DriSate® Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate. |
| Quantity | 139 |
| Distribution | US Distribution to the state of NY |
| Initiated | 2018-04-07 |
| Classified | 2018-05-14 |
| Terminated | 2018-10-01 |
| Recall number | Z-1869-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Rockwell Medical, Inc (Z-1869-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79878/
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