# FDA recall Z-0913-2025

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

## Product

Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL     , Catalog Number: PE23NSMEA; 2 ) KIT, NASAL     , Catalog Number: PE23NSMEC; 3 ) KIT,SEPTOPLASTY NEW HAN    , Catalog Number: PE23SENLA; 4 ) KIT,SEPTOPLASTY NEW HAN    , Catalog Number: PE23SENLC; 5 ) KIT, EAR       , Catalog Number: PE30EAGT6; 6 ) KIT, EAR       , Catalog Number: PE30EAGT7; 7 ) KIT, EAR       , Catalog Number: PE30EAGT8; 8 ) KIT, EAR       , Catalog Number: PE30EAGT9; 9 ) KIT, EAR       , Catalog Number: PE30EAGTB; 10 ) KIT, EAR       , Catalog Number: PE30EAGTC; 11 ) KIT, EAR       , Catalog Number: PE30EAGTD; 12 ) KIT, NASAL     , Catalog Number: PE35NSB10; 13 ) KIT, NASAL     , Catalog Number: PE35NSB11; 14 ) KIT, NASAL     , Catalog Number: PE35NSB12; 15 ) KIT, NASAL     , Catalog Number: PE35NSB13; 16 ) KIT, NASAL     , Catalog Number: PE35NSB14; 17 ) KIT, NASAL     , Catalog Number: PE35NSB15; 18 ) KIT, NASAL     , Catalog Number: PE35NSB16; 19 ) KIT, NASAL     , Catalo

## 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-0913-2025
- **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-0913-2025

## Citation

> AI Analytics. FDA recall Z-0913-2025. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-0913-2025. Source: US FDA. Licensed CC0.

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