Medical Device Recall: Bicarby Dialysate; Model number: RFP-400-G;
Fresenius Medical Care Holdings, Inc. · May 7, 2026
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.
Distribution
Domestic: TX.
States Affected
TX
Quantity Affected
4752
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2401-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.