Recall archive / FDA device enforcement
Bicarby Dialysate; Model number: RFP-400-G; — FDA record Z-2401-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 7, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 4752
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2401-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: TX.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 17, 2026
- Recall initiation date
- May 7, 2026
- Center classification date
- Jun 11, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.