Bicarby Dialysate recall: Labeling Error
Bicarby Dialysate; Model number: RFP-400-G;
Why was Bicarby Dialysate recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
- Product
- Bicarby Dialysate; Model number: RFP-400-G;
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 4752
- Distribution
- Domestic: TX.
- Recall date
- June 17, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)