Recall
FDAHealthMay 7, 2026

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

⚠️ 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 this relevant to me?

Geography
TX
Source agency
FDA
Category
Health
Published
May 7, 2026

Domestic: TX.

What's affected?

Product
Bicarby Dialysate; Model number: RFP-400-G;
Lot code
25SG06026

Additional details

Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 4752.

View original FDA notice →

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