DriSate¿ Product Code DR-145 The acid concentrate powders and liquids… — Class II medical device recall Z-1869-2018
Terminated recall by Rockwell Medical, Inc, reported 2018-05-23, distributed in NY. A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate
| Recall number | Z-1869-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rockwell Medical, Inc, Wixom, MI, United States |
| Recall initiated | 2018-04-07 |
| Classified | 2018-05-14 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2018-10-01 |
| Distributed | NY |
| Quantity | 139 |
| Lot numbers | 28562-0220171 |
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.
Reason for recall
A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
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-1869-2018. 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.