# FDA recall Z-1381-2024

> **Medivance Inc.** · Class II · device recall initiated 2024-02-16.

## Product

Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

## Reason for recall

Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling  performance of the pads that are part of a temperature management system.

## Distribution

Worldwide - US Nationwide distribution including in the states of IL, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Australia, Singapore, South Korea, Taiwan, Japan, China, Thailand.

## Key facts

- **Recall number:** Z-1381-2024
- **Recalling firm:** Medivance Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-16
- **Report date:** 2024-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1381-2024

## Citation

> AI Analytics. FDA recall Z-1381-2024. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-1381-2024. Source: US FDA. Licensed CC0.

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