FDA-Device2017-11-29Class II
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
3M Company - Health Care Business
Hazard
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.
Sold states
CA, MI, IL, MO, MN, GA, and Canada, Switzerland
Affected count
153 cases (3825 sensors)
Manufactured in
3m Center 2510 Conway Ave , B# 275-5-W-6, N/A, Saint Paul, MN, United States
Products
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0114-2018Don't want to check this manually?
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