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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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