# FDA recall Z-2721-2024

> **Fresenius Kabi USA, LLC** · Class I · device recall initiated 2024-08-01.

## Product

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

## Reason for recall

A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).

## Distribution

US Distribution to states of: CO, ID, NJ, UT.

## Key facts

- **Recall number:** Z-2721-2024
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-01
- **Report date:** 2024-09-11

- **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-2721-2024

## Citation

> AI Analytics. FDA recall Z-2721-2024. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-2721-2024. Source: US FDA. Licensed CC0.

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