# FDA recall Z-1097-2021

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2021-01-07.

## Product

Gown Kendall Blue XXL, SKU CT5102    Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

## Reason for recall

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

## Distribution

Global Distribution:  US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH,  OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.

## Key facts

- **Recall number:** Z-1097-2021
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-01-07
- **Report date:** 2021-02-17

- **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-1097-2021

## Citation

> AI Analytics. FDA recall Z-1097-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1097-2021. Source: US FDA. Licensed CC0.

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