Bicarby Dialysate — Class II medical device recall Z-2401-2026
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2026-06-17, distributed in TX. There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot nu
| Recall number | Z-2401-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2026-05-07 |
| Classified | 2026-06-11 |
| Reported by FDA | 2026-06-17 |
| Distributed | TX |
| Quantity | 4,752 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00840861102839 |
| Lot numbers | 25SG06026, 25SG06027 |
| Model numbers | RFP-400-G |
Product
Bicarby Dialysate; Model number: RFP-400-G;
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2401-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.