# FDA recall Z-2364-2019

> **CooperSurgical, Inc.** · Class II · device recall initiated 2019-07-08.

## Product

TransWarmer Warming Infant Transport Mattress, Model no. 20421    Product  Usage:  The TransWarmer¿ Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two hours when cold stress is a concern. The patented WarmGel heats up to 104 (when starting from 75 ) in 60 seconds or less. The product is sold in boxes of 6 Infant Transport Mattresses per box. The intended use of the product is to provide warmth during infant transport within the hospital or between hospitals.

## Reason for recall

The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequences, such as skin burns. some products do not contain the updated IFU.

## Distribution

Worldwide Distribution - US Nationwide in all 50 states. International distribution to Australia, Brazil, Canada, Ecuador, Germany, Gibraltar, India, Ireland, Kuwait, Macedonia, New Zealand, Oman, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, South Korea, Switzerland, United Arab Emirates, & United Kingdom.

## Key facts

- **Recall number:** Z-2364-2019
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-08
- **Report date:** 2019-09-04
- **Termination date:** 2020-05-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Trumbull, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2364-2019

## Citation

> AI Analytics. FDA recall Z-2364-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2364-2019. Source: US FDA. Licensed CC0.

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