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3M Company - Health Care Business recalls 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
Recalled November 29, 2017 · FDA recall Z-0114-2018 · 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. · FDA Class II
Units
153 cases (3825 sensors)
Sold at
CA, MI, IL, MO, MN, GA, and Canada, Switzerland
Description
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.
Product
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
Manufacturer(s)
3M Company - Health Care Business
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →