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.
Other recalls by Fresenius Medical Care Holdings
- 5008X Blood Tubing Set, 24 units per case
FDA Device · Class II · 2026-07-15 · Fresenius Medical Care Holdings - Bicarby Dialysate
FDA Device · Class II · 2026-06-17 · Fresenius Medical Care Holdings - DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L…
FDA Drug · Class II · 2026-05-13 · Fresenius Medical Care Holdings - DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L…
FDA Drug · Class II · 2026-05-13 · Fresenius Medical Care Holdings - 5008X CAREsystem +CLiC +CDX
FDA Device · Class II · 2025-12-24 · Fresenius Medical Care Holdings
All Fresenius Medical Care Holdings recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2321-2026%22
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