Bicarby Dialysate
Fresenius Medical Care is recalling Bicarby Dialysate due to a GTIN labeling error that may result in the use of an incorrect potassium solution.
Do not rely solely on the GTIN for product identification. Verify the product code and solution concentration using the lot number and printed labeling on the product bag and case before use.
Why it was recalled
Fresenius Medical Care is recalling Bicarby Dialysate due to a labeling error involving the Global Trade Item Number (GTIN). While the case labeling, lot number, and bag labeling correctly identify the product and solution, the incorrect GTIN could lead to the unrecognized use of a potassium solution with a concentration that differs from the patient's prescription.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
RFP-400-G
- Model
- RFP-400-G
Where it was sold
Distributed in Texas.
Official source
Other recent recalls from Fresenius Medical Care Holdings, Inc.
Editorial summary by Recall Canary · last updated 2026-06-12 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification