FDAFDA · Food and drugs·Recall number Z-2401-2026
Bicarby Dialysate; Model number: RFP-400-G;
Published June 17, 2026 · Recall initiated: May 7, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Domestic: TX.
- Lot
- Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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