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Medium risk Drugs & MedicationsClass II

Fresenius Medical Care Holdings, Inc. Recall

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

Updated May 7, 2026

Fresenius Medical Care Holdings, Inc. is recalling Bicarby Dialysate; Model number: RFP-400-G;. 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.

Is the Fresenius Medical Care Holdings, Inc. recalled? Yes. This product was recalled by FDA on May 7, 2026. Details below.

What is recalled

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

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

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.

Brands affected

Fresenius Medical Care Holdings, Inc.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-2401-2026
Classification
Class II
Recalled
May 7, 2026
Read the official notice

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