Fresenius Bicarby Dialysate recalled for incorrect GTIN labeling risking wrong potassium concentration
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.
From the FDA notice · Read the official notice ↗ · All Fresenius Medical Care recalls
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Bicarby Dialysate; Model number: RFP-400-G;
- Sold in
- Domestic: TX.
- Made for
- Adults (0 months and older)
Details
- Units affected
- 4752
- Illnesses reported
- None reported
- Manufactured in
- 920 Winter St Bld 920, N/A, Waltham, MA, United States
- Classification
- Class II
- Recall number
- Z-2401-2026
In the FDA's words
- Description
- Bicarby Dialysate; Model number: RFP-400-G; 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. Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027; Distribution: Domestic: TX. Affected quantity: 4752
- 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.