# FDA recall Z-0599-2018

> **3M Company - Health Care Business** · Class II · device recall initiated 2018-01-23.

## Product

3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700     The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.

## Reason for recall

Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use.

## Distribution

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Chile, Costa Rica, Deutschland GMBH, Dominican,  Ecuador, Hong Kong, Indonesia, Japan, Korea, Paraguay, Philippines, New Zealand, Shanghai, Thailand,  and Uruguay.

## Key facts

- **Recall number:** Z-0599-2018
- **Recalling firm:** 3M Company - Health Care Business
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-23
- **Report date:** 2018-02-21
- **Termination date:** 2020-08-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0599-2018

## Citation

> AI Analytics. FDA recall Z-0599-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0599-2018. Source: US FDA. Licensed CC0.

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