Fresenius Medical Care Holdings, Inc. recalls Bicarby Dialysate

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.

Bicarby Dialysate; Model number: RFP-400-G;

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.

• FDA enforcement recordOfficial FDA database entry for Z-2401-2026
• FDA 510(k) clearance · K243786The device's official FDA premarket clearance record
• FDA device classification · KPOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5820The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Fresenius Medical Care Holdings, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.