# FDA recall Z-0342-2025

> **The Metrix Company** · Class II · device recall initiated 2024-10-09.

## Product

Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

## Reason for recall

A limited number of IV bags have been found to leak during filling.

## Distribution

Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.

## Key facts

- **Recall number:** Z-0342-2025
- **Recalling firm:** The Metrix Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-09
- **Report date:** 2024-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dubuque, IA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0342-2025

## Citation

> AI Analytics. FDA recall Z-0342-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0342-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*