Fresenius Medical Care Holdings, Inc. — 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.
Is this relevant to me?
- Geography
- TX
- Source agency
- FDA
- Category
- Health
- Published
- May 7, 2026
Domestic: TX.
What's affected?
- Product
- Bicarby Dialysate; Model number: RFP-400-G;
- Lot code
- 25SG06026
Additional details
Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4752.
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