# FDA recall Z-0917-2025

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

## Product

Cardinal Health Presource Kits:  1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ;  2) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH1;  3) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH2;  4) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH3;  5) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMH4;  6) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH5;  7) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH6;  8) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHA;  9) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHB;  10) KIT,H N FREE FLAP  , Catalog Number: PWHFHNAMHC;  11) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHD;  12) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHE;  13) ENT PACK     , Catalog Number: SEN55ENSH2;  14) ENT PACK     , Catalog Number: SEN55ENSHA;  15) ENT PACK     , Catalog Number: SEN55ENSHB;  16) EYE PACK     , Catalog Number: SEY51EYKIK;  17) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHH1;  18) PLASTIC EYE PACK   , Catalog Number: SEYOCPEHH2;  19) PLASTIC EYE PACK   , Cata

## 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-0917-2025
- **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-0917-2025

## Citation

> AI Analytics. FDA recall Z-0917-2025. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-0917-2025. Source: US FDA. Licensed CC0.

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