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High risk Medical DevicesClass II

Fresenius Bicarby Dialysate RFP-400-G Recall

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

Updated May 7, 2026

Fresenius Bicarby Dialysate (Model RFP-400-G) has an incorrect barcode label that could lead to the wrong potassium concentration being used during dialysis. The correct product information is still on the case and lot labels, but if the barcode is scanned alone, it may identify the wrong solution.

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, made by Fresenius Medical Care Holdings, Inc. The issue is in the barcode (GTIN) labeling on the product packaging.

Am I affected

You are affected if you use Bicarby Dialysate Model RFP-400-G. Check your dialysate bags for the model number on the packaging. If you scan the barcode as the only check for product identity, there is a risk of using the wrong potassium concentration.

What to do right now

Do not rely solely on the barcode to identify this product. Always verify the product code and potassium concentration using the case label and lot number printed on the bag itself. If you have already opened and used a bag, confirm with your dialysis provider that you received the correct solution for your prescription.

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
Medical Devices
Recall ID
fda-Z-2401-2026
Classification
Class II
Recalled
May 7, 2026
Read the official notice

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