Fresenius Bicarby Dialysate recalled for incorrect GTIN labeling risking wrong potassium concentration
Fresenius Bicarby Dialysate recalled for GTIN labeling error
Fresenius Medical Care's Bicarby Dialysate (Model RFP-400-G) has incorrect barcode labeling on some units. While the case label and printed information are correct, scanning the GTIN barcode alone could lead to identification errors. This could result in use of a dialysate with a potassium concentration different from what was prescribed.
- Check the case labeling and printed product information before using, not just the GTIN barcode.
- Contact your dialysis provider or Fresenius if you have questions about your dialysate lot number.
- Do not rely solely on barcode scanning to verify the potassium concentration matches your prescription.
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2401-2026More Fresenius Medical Care Holdings, Inc. recalls
- FDA-Device2026-06-17Fresenius Bicarby Dialysate recalled for luer-lock leak and slip hazard risk
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