FDA Medical Device Recalls (openFDA)
Rockwell Medical, Inc: 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.
- Recall number
- Z-1869-2018
- Recalling firm
- Rockwell Medical, Inc
- 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.
- Status
- Terminated
- Initiated
- 2018-04-07
- Posted
- not on file
- Terminated
- 2018-10-01
- Reason
- A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
- Root cause
- Employee error
- Action
- Removal notification involved one customer and two facilities. The two facilities receiving the DR-145 kit lot were contacted directly via phone, email, and issuance of a RGA to return the product. Stock retrieval was completed by 4/7/17. See attached email and RGA. Communication was already completed and stock was retrieved. Discard and/or return via RGA provided The complaint documented a stock reconciliation in the complaint and all units were accounted for. The two customer facilities involved responded directly Affected kits were reworked to remove and replace the nonconforming dextrose bag. For further questions, please call (864) 849-0530.
- Quantity
- 139
- Distribution
- US Distribution to the state of NY
- Lot, serial or model codes
- Lot 28562-0220171
- 510(k) numbers
- K981003
- PMA numbers
- not on file
- Product code
- KPO
- Firm FEI
- 3001236991
- Firm city
- Wixom
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28