Bicarby Dialysate recall (Fresenius Medical Care Holdings, Inc.)
Medical deviceClass IIOngoing
Summary: Fresenius Medical Care Holdings, Inc. is recalling 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.
What is being recalled
Bicarby Dialysate; Model number: RFP-400-G;
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Domestic: TX. (states named: Texas)
How to tell if yours is affected
Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2401-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 7, 2026 |
| Reported | June 17, 2026 |
| Company | Fresenius Medical Care Holdings, Inc. |
| Company location | Waltham, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 4752 |
More recalls from Fresenius Medical Care Holdings, Inc. · all medical device recalls · recalls from May 2026