Fresenius Medical Care Holdings, Inc. recalls Bicarby" Dialysate

Recalling company

Fresenius Medical Care Holdings, Inc.

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

May 12, 2026

Reported

Jun 17, 2026

Distribution

US Nationwide distribution in the states of NY, TN and TX.

Status

Ongoing

Quantity

1,756,108 units

Lot / codes

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

Company location

Waltham, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-2321-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2321-2026 in the FDA Enforcement Report. Also see FDA recall press releases.