# FDA recall Z-0915-2025

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

## Product

Cardinal Health Presource Kits: 1)  CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2)  CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC45; 6)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC46; 7)  CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC4D; 8)  KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJU2; 9)  KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJUE; 10)  KIT, CRANIOTOMY PMH  , Catalog Number: PN08CPPCA; 11)  KIT, NEURO  , Catalog Number: PN11NEXX1; 12)  KIT, NEURO  , Catalog Number: PN11NEXXA; 13)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBW2; 14)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBW3; 15)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBWG; 16)  KIT, NEUROSURGERY SKULL BASE   , Catalog Number: PN13CRBWH; 17)  KIT, MAJOR NEURO    

## 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-0915-2025
- **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-0915-2025

## Citation

> AI Analytics. FDA recall Z-0915-2025. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-0915-2025. Source: US FDA. Licensed CC0.

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