FDA Device recall Z-2401-2026
Bicarby Dialysate
- FDA Device
- Class II
- ongoing
- Published 2026-06-17
On 2026-06-17 the FDA classified a Class II recall of Bicarby Dialysate by Fresenius Medical Care Holdings, citing 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 pr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2401-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-07 |
| Published | 2026-06-17 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | TX |
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.
Identifiers
| code_info | Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2401-2026%22
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