3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
Reported: November 29, 2017 Initiated: October 17, 2017 #Z-0114-2018
Product Description
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.
Details
- Recalling Firm
- 3M Company - Health Care Business
- Units Affected
- 153 cases (3825 sensors)
- Distribution
- CA, MI, IL, MO, MN, GA, and Canada, Switzerland
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000). Recalled by 3M Company - Health Care Business. Units affected: 153 cases (3825 sensors).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2017. Severity: Moderate. Recall number: Z-0114-2018.
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