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Fresenius Medical Care Holdings, Inc. recalls Bicarby Dialysate; Model number: RFP-400-G;
Recalled June 17, 2026 · FDA recall Z-2401-2026 · Fresenius Medical Care Holdings
Hazard
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. · FDA Class II
Units
4752
Sold at
Domestic: TX.
Description
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.
Product
Bicarby Dialysate; Model number: RFP-400-G;
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →