# FDA recall Z-2095-2021

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2021-06-09.

## Product

Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product   SKU MH00002N    The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws

## Reason for recall

A caution statement is being added to remind the  user to activate away from face and infant as reports of pack rupture or leaking during activation may  resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.

## Distribution

US Nationwide Distribution to states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA ,ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.

## Key facts

- **Recall number:** Z-2095-2021
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-09
- **Report date:** 2021-07-28
- **Termination date:** 2023-11-01

- **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-2095-2021

## Citation

> AI Analytics. FDA recall Z-2095-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-2095-2021. Source: US FDA. Licensed CC0.

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