FDA Device recall Z-1869-2018
DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be use…
- FDA Device
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be use… by Rockwell Medical, citing A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1869-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-07 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Rockwell Medical |
| Distribution | NY |
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
A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
Identifiers
| code_info | Lot 28562-0220171 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1869-2018%22
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