Fresenius Medical Care recalls Bicarby Dialysate model RFP-400-G due to incorrect GTIN labeling that may lead to wrong potassium solution use. Affected units have specific lot codes.
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.
Fresenius Medical Care is recalling Bicarby Dialysate model RFP-400-G because its GTIN labeling error could cause incorrect potassium solution use. This risk affects patients receiving dialysis treatments with the recalled product.
The product's GTIN labeling error means the wrong potassium solution concentration could be used if the incorrect label is scanned. This might lead to improper treatment if the label is misinterpreted as the sole identifier.
Patients using Bicarby Dialysate model RFP-400-G for dialysis treatments are most at risk. Healthcare providers who handle the product may also be affected.
Check for model number RFP-400-G on the product. Affected units have lot codes 25SG06026 or 25SG06027. The product may have UDI-DI code 00840861102839.
Verify the model number and lot codes on the product to confirm if it is affected.
The recall is due to an error in the GTIN labeling that could lead to using the wrong potassium solution concentration if the incorrect label is scanned.
The model number is RFP-400-G.
Lot codes 25SG06026 and 25SG06027 are affected.
We’ve drafted a message you can send Fresenius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-2401-2026 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-2401-2026 from Fresenius Medical Care. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
