# FDA recall Z-1012-2020

> **Cardinal Health** · Class II · device recall initiated 2020-01-11.

## Product

AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC

## Reason for recall

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

## Distribution

Worldwide distribution  US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.

## Key facts

- **Recall number:** Z-1012-2020
- **Recalling firm:** Cardinal Health
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-11
- **Report date:** 2020-02-12
- **Termination date:** 2023-01-19

- **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-1012-2020

## Citation

> AI Analytics. FDA recall Z-1012-2020. Retrieved 2026-05-23 from https://api.ai-analytics.org/recall/Z-1012-2020. Source: US FDA. Licensed CC0.

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