# FDA recall Z-1301-2020

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2020-01-31.

## Product

Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

## Reason for recall

The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.

## Distribution

US Nationwide. Chile, Israel, UAE.

## Key facts

- **Recall number:** Z-1301-2020
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-31
- **Report date:** 2020-02-26
- **Termination date:** 2023-02-01

- **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-1301-2020

## Citation

> AI Analytics. FDA recall Z-1301-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1301-2020. Source: US FDA. Licensed CC0.

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