# FDA recall Z-0310-2025

> **Cardinal Health 200, LLC** · Class I · device recall initiated 2024-09-25.

## Product

Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777

## Reason for recall

Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0310-2025
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-25
- **Report date:** 2024-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukegan, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0310-2025

## Citation

> AI Analytics. FDA recall Z-0310-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0310-2025. Source: US FDA. Licensed CC0.

---

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