# FDA recall Z-0114-2018

> **3M Company - Health Care Business** · Class II · device recall initiated 2017-10-17.

## Product

3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)

## Reason for recall

During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature readout that is lower than the patients actual temperature.

## Distribution

CA, MI, IL, MO, MN, GA, and Canada, Switzerland

## Key facts

- **Recall number:** Z-0114-2018
- **Recalling firm:** 3M Company - Health Care Business
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-17
- **Report date:** 2017-11-29
- **Termination date:** 2020-11-03

- **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-0114-2018

## Citation

> AI Analytics. FDA recall Z-0114-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0114-2018. Source: US FDA. Licensed CC0.

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