Z-2401-2026Class II

Bicarby Dialysate; Model number: RFP-400-G

Name: Z-2401-2026 Bicarby Dialysate; Model number: RFP-400-G
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2026-05-07
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2026-05-07 / Open, Classified / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Bicarby Dialysate; Model number: RFP-400-G on 2026-05-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2401-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-07
Posted: 2026-06-11
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Bicarby Dialysate; Model number: RFP-400-G;
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 4752
Distribution: Domestic: TX.
Product codes and lots: Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2401-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2401-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-11

Product code KPO

K243786Class IIBicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLC / cleared 2025-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)