FDA recall, , Moderate risk
Fresenius Medical Care Holdings Bicarby Dialysate
Bicarby Dialysate has an error in the labeling of the GTIN, which may lead to unrecognized use of a potassium solution with a differing concentration.
Summary by Recall Canary from the FDA notice
What happened
Fresenius Medical Care Holdings, Inc., of Waltham, Massachusetts, began a recall of Bicarby Dialysate, model number RFP-400-G, on May 7, 2026. The FDA added the recall to its Enforcement Report on June 11, 2026. The reason is an error in the labeling of the GTIN on the product; when scanned, the case labeling, lot number, and printed labeling correctly identify 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. The product was distributed domestically in Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI, lot code and model code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Bicarby Dialysate
- UDI-DI
- 00840861102839
- Model code
- RFP-400-G
- Lot code
- 25SG06026
- 25SG06027
RFP-400-g
Recall details
- Company began the recall
- Sold in
Domestic: Texas.
- Company
- Fresenius Medical Care Holdings, Inc.Waltham, Massachusetts
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98892
- Recall number
- Z-2401-2026
All recalls from Fresenius Medical Care Holdings, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
