# FDA recall Z-1129-2025

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

## Product

Cardinal Health Presource Kits:  1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B;  2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D  3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103  4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T  5) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10U  6) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10X  7) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10Y  8) SLH AAA PACK, Catalog Number:SCV13AASLA  9) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAF10  10) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH4  11) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH5  12) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH6  13) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH7  14) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH8  15) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH9  16) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHP  17) MICROVASCULAR FREE 

## Reason for recall

Potential for 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-1129-2025
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-08
- **Report date:** 2025-02-19

- **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-1129-2025

## Citation

> AI Analytics. FDA recall Z-1129-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1129-2025. Source: US FDA. Licensed CC0.

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