# FDA recall Z-2038-2019

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2019-04-30.

## Product

Monoject Standard Hypodermic Needle, 16 G x 1-1/2"  Item code: 8881200037

## Reason for recall

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

## Distribution

Nationwide  Foreign: AU, BE, CA, DK, FI, GB, IE, NL

## Key facts

- **Recall number:** Z-2038-2019
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2019-04-30
- **Report date:** 2019-07-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2038-2019

## Citation

> AI Analytics. FDA recall Z-2038-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2038-2019. Source: US FDA. Licensed CC0.

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