Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0114-2018 — 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)

U.S. FDA — Device Enforcement · United States · 2017-10-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0114-2018
Date of alert
2017-10-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
3M Company - Health Care Business
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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