FDAMay 7, 2026device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

fresenius medical carefreseniusfresenius medical

UPCs

00840861102839

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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