Fresenius Medical Care Holdings, Inc. recalls Bicarby Dialysate
- Recalling company
- Fresenius Medical Care Holdings, Inc.
- Product
- Bicarby Dialysate; Model number: RFP-400-G;
- Reason
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- May 7, 2026
- Reported
- Jun 17, 2026
- Distribution
- Domestic: TX.
- Status
- Ongoing
- Quantity
- 4752
- Lot / codes
- Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
- Company location
- Waltham, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2401-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2401-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.