# FDA recall Z-0859-2024

> **Cardinal Health 200, LLC** · Class I · device recall initiated 2023-12-28.

## Product

Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE

## Reason for recall

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

## Distribution

Distribution US nationwide and Canada.  Foreign distribution updated 9/6/2024 to only include Canada.

## Key facts

- **Recall number:** Z-0859-2024
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-28
- **Report date:** 2024-02-14

- **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-0859-2024

## Citation

> AI Analytics. FDA recall Z-0859-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0859-2024. Source: US FDA. Licensed CC0.

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