# FDA recall Z-1158-2023

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2022-11-18.

## Product

Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device  CATALOG #: 01-5799A

## Reason for recall

Presource Kits contains the ICU MicroClave Clear  Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which  may lead to fluid leaks and loss of fluid path integrity

## Distribution

US Nationwide distribution in the states of GA, PA.

## Key facts

- **Recall number:** Z-1158-2023
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-18
- **Report date:** 2023-03-01

- **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-1158-2023

## Citation

> AI Analytics. FDA recall Z-1158-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1158-2023. Source: US FDA. Licensed CC0.

---

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