# FDA recall Z-0848-2024

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

## Product

Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit  Connection System, REF 412SE

## Reason for recall

The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps.  As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

## Distribution

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

## Key facts

- **Recall number:** Z-0848-2024
- **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-0848-2024

## Citation

> AI Analytics. FDA recall Z-0848-2024. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-0848-2024. Source: US FDA. Licensed CC0.

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