Recall Z-0114-2018— 3M Company - Health Care Business

Name: FDA recall Z-0114-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-17

Class II · Terminated

Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2017-10-17, terminated 2020-11-03. It names one FDA 510(k) clearance: K120412. Product: 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000). 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: 3M Company - Health Care Business
Classification: Class II
Status: Terminated
Initiated: 2017-10-17
Terminated: 2020-11-03
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K120412 — 3M SPOTON TEMPERATURE MONITORING SYSTEMArizant Healthcare, Inc.·cleared 2012-05-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.