# FDA recall Z-2235-2025

> **Fresenius Kabi USA, LLC** · Class II · device recall initiated 2025-06-24.

## Product

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.

## Reason for recall

Potential for external cassette leaks

## Distribution

US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.

## Key facts

- **Recall number:** Z-2235-2025
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-24
- **Report date:** 2025-08-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2235-2025

## Citation

> AI Analytics. FDA recall Z-2235-2025. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-2235-2025. Source: US FDA. Licensed CC0.

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