FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: Bicarby Dialysate; Model number: RFP-400-G;
- Recall number
- Z-2401-2026
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- Bicarby Dialysate; Model number: RFP-400-G;
- Status
- Open, Classified
- Initiated
- 2026-05-07
- Posted
- 2026-06-11
- Terminated
- not on file
- Reason
- There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
- Root cause
- Process control
- Action
- On 5/7/2026 an URGENT MEDICAL DEVICE RECALL letters were sent to customers. At this time, FMCRTG is providing this recall notice to alert you of the potential risks associated with the labeling error, and to ask that you identify, segregate, and discontinue use of affected lots, 25SG06026 and 25SG06027, of RFP-400-G Bicarby Dialysate. FMCRTG is requiring the return of the affected Bicarby Dialysate lots. FMCRTG will replace all remaining stock of affected product lots. For product technical questions or concerns, please contact Technical Support at 1-800-323-2732 or Customer Support at 1-800-323-5188 between 8:30AM 4:30PM Eastern Daylight Time. For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.
- Quantity
- 4752
- Distribution
- Domestic: TX.
- Lot, serial or model codes
- Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
- 510(k) numbers
- ["K243786"]
- PMA numbers
- not on file
- Product code
- KPO
- Firm FEI
- 3001451489
- Firm city
- Waltham
- Firm state
- MA
- 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