FDA Device recall Z-2321-2026
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 given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2321-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-12 |
| Published | 2026-06-17 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Reason
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
Identifiers
| code_info | Model Number: RFP-400-G; UDI-DI: 00840861102839; 2. Model Number: RFP-401-G; UDI-DI: 00840861102853; 3. Model Number: R…Model Number: RFP-400-G; UDI-DI: 00840861102839; 2. Model Number: RFP-401-G; UDI-DI: 00840861102853; 3. Model Number: RFP-402-G; UDI-DI: 00840861102822; 4. Model Number: RFP-404-G; UDI-DI: 00840861102914; 5. Model Number: RFP-407-G; UDI-DI: 00840861102846: 6. Model Number: RFP-456-G; UDI-DI: 00840861102945; All lots produced from January 13, 2025, through lot 26AG02019 on January 13, 2026 |
|---|
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-2321-2026%22
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