Cl II 3M Bair Hugger(TM) Normothermia System

Company:3M Company – Health Care Business
Date of Enforcement Report 11/29/2017
Class lI:

PRODUCT

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

REASON
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.

RECALLING FIRM/MANUFACTURER
3M Company – Health Care Business, Saint Paul, MN on 10/17/2017. Voluntary firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
153 cases (3825 sensors)

DISTRIBUTION
CA, MI, IL, MO, MN, GA, and Canada, Switzerland

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