FDA recall Z-0114-2018

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-10-17

Report date

2017-11-29

Termination date

2020-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0114-2018