Medical device recalls Moderate risk

3M Company - Health Care Business recalls 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)

Recall date
October 17, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0114-2018
FDA classification
Class II
Brand / firm
3M Company - Health Care Business
Sold / distributed
CA, MI, IL, MO, MN, GA, and Canada, Switzerland

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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