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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall 3M Bair Hugger(TM) Normothermia System see related information
Date Initiated by Firm October 17, 2017
Create Date November 18, 2017
Recall Status1 Terminated 3 on November 03, 2020
Recall Number Z-0114-2018
Recall Event ID 78327
510(K)Number K120412  
Product Classification Thermometer, electronic, clinical - Product Code FLL
Product 3M 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
Action The 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 Commerce 153 cases (3825 sensors)
Distribution CA, MI, IL, MO, MN, GA, and Canada, Switzerland
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FLL and Original Applicant = ARIZANT HEALTHCARE INC.
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