# FDA recall Z-0914-2025

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2024-11-08.

## Product

Cardinal Health Presource Kits:  1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10  2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5  3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6  4 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH7  5 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH8  6 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH9  7 ) KIT, FETAL SURGERY , Catalog Number PB11FSCHR

## Reason for recall

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

## Key facts

- **Recall number:** Z-0914-2025
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-08
- **Report date:** 2025-01-22

- **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-0914-2025

## Citation

> AI Analytics. FDA recall Z-0914-2025. Retrieved 2026-09-12 from https://api.ai-analytics.org/recall/Z-0914-2025. Source: US FDA. Licensed CC0.

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