FDA DevicesClass II
Bicarby Dialysate; Model number: RFP-400-G;
Published: June 17, 2026Recall ID: Z-2401-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Bicarby Dialysate; Model number: RFP-400-G;
Additional Source Details
| Field | Value |
|---|---|
| City | Waltham |
| State | MA |
| Event id | 98892 |
| Address 1 | 920 Winter St Bld 920 |
| Address 2 | N/A |
| Code info | Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027; |
| Postal code | 02451-1521 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 4752 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260507 |
| Initial firm notification | Letter |
| Center classification date | 20260611 |
Overview
- Recalling FirmFresenius Medical Care Holdings, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionDomestic: TX.