# FDA recall Z-3016-2020

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2020-07-30.

## Product

KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.

## Reason for recall

Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.

## Distribution

US Nationwide distribution including the state of North Carolina.

## Key facts

- **Recall number:** Z-3016-2020
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-30
- **Report date:** 2020-10-07
- **Termination date:** 2021-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fort Mill, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3016-2020

## Citation

> AI Analytics. FDA recall Z-3016-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-3016-2020. Source: US FDA. Licensed CC0.

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