# FDA recall Z-2321-2026

> **Fresenius Medical Care Holdings, Inc.** · Class II · device recall initiated 2026-05-12.

## 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 for recall

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.

## Distribution

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

## Key facts

- **Recall number:** Z-2321-2026
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-12
- **Report date:** 2026-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2321-2026

## Citation

> MORVS. FDA recall Z-2321-2026. Retrieved 2026-10-24 from https://api.morvs.ai/recall/Z-2321-2026. Source: US FDA. Licensed CC0.

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