Fresenius recalls Bicarby Dialysate over wrong barcode number on label
The barcode number (GTIN) on the product is labeled wrong, so if it is the only thing used to identify the product, a patient could get a potassium level different from what was prescribed.
What to do
Do not rely on the barcode number alone to identify the product. Check the case label, lot number and printed label on the bag, which correctly show the product code and solution.
Recall details
- Product
- 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.
- Units
- 4752
- Where sold
- Domestic: TX.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- June 11, 2026
- Recall started
- May 7, 2026
- FDA enforcement report
- June 17, 2026
- Identifiers
- Codes: Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
- FDA recall number: Z-2401-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- Bicarby Dialysate; Model number: RFP-400-G;
- Reason for recall
- 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.
- Classification
- Class II (Ongoing)
- Distribution
- Domestic: TX.
- Quantity
- 4752
Related recalls
Fresenius recalls Bicarby dialysate over leaks that can cause slip and fall hazard
The luer-lock connector on Bicarby dialysate can leak when users handle the frangible and tubing to prepare it for treatment, and fluid on the floor could cause someone to slip and fall.
Fresenius Medical Care Holdings, Inc. · 1,756,108 units