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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