Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall 3M Bair Hugger(TM) Normothermia System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall 3M Bair Hugger(TM) Normothermia Systemsee related information
Date Initiated by FirmOctober 17, 2017
Create DateNovember 18, 2017
Recall Status1 Terminated 3 on November 03, 2020
Recall NumberZ-0114-2018
Recall Event ID 78327
510(K)NumberK120412 
Product Classification Thermometer, electronic, clinical - Product Code FLL
Product3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
Code Information Lot Numbers: 17230, Exp. 2020 Aug 18; 17233, Exp. 2020 Aug 21; 17234, Exp. 2020 Aug 22; 17241, Exp. 2020 Aug 29
Recalling Firm/
Manufacturer		 3M Company - Health Care Business
3m Center 2510 Conway Ave , B# 275-5-W-6
Saint Paul MN 55144-0001
For Additional Information Contact
651-733-1110
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionThe firm initiated their recall on 10/17/2017 via mail. International subsidiaries were notified via email, also on October 17, 2017.Distributors were asked to notify their customers and all direct consignees were directed to dispose of the product on site.
Quantity in Commerce153 cases (3825 sensors)
DistributionCA, MI, IL, MO, MN, GA, and Canada, Switzerland
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FLL
-
-