• 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(M) Normothermia System, Full Access Underbody Warming Blanket

  • 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(M) Normothermia System, Full Access Underbody Warming Blanket see related information
Date Initiated by Firm January 23, 2018
Create Date February 12, 2018
Recall Status1 Open3, Classified
Recall Number Z-0598-2018
Recall Event ID 79002
510(K)Number K060865  
Product Classification System, thermal regulating - Product Code DWJ
Product 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500

The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.
Code Information Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366
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
Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use.
FDA Determined
Cause 2
Finished device change control
Action The firm, 3M, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 1/19/2018 to its customers on 01/23/2018. The end user letter requested the following: "Actions Required: 1) Please immediately identify the affected product listed above, remove from your inventory and DO NOT USE. 2) Follow the instructions on the attached Customer Product Recall Acknowledgement Form, complete the form and return it to 3M via email at 3Mhealthcare@montage72.com. 3) Please dispose of all affected product per your institutional protocol and document disposal in the recall acknowledgment form." The distributor letter requested the following: "Actions Required: 1. Immediately discontinue distribution of the 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, with the referenced lot numbers above. 2. Determine if any stock of the 3M" Bair Hugger" Full Access Underbody Warming Blanket, Models 63500 and 63700, with the referenced lot numbers above remains in your inventory. 3. Complete the attached Distributor Product Recall Acknowledgement Form and return to 3M via email at 3Mhealthcare@montage72.com. It is important to notify 3M whether or not your facility has any inventory of this product. 4. Notify any of your customers who may have received the lots. Please use the attached customer notice and form provided in your communications to the customer. Customers should complete and return the enclosed form to 3M per the instructions on the form. Customers should not use the affected product and dispose per institutional protocol. 5. Dispose of any affected product in your inventory and document disposal in the recall acknowledgment form." If you have questions regarding this matter, please contact the 3M Health Care Customer Helpline at 1-800-228-3957, option #6, Monday through Friday, 7:30 a.m.  6:00 p.m. Central Daylight Time.
Quantity in Commerce 33108 cases of 5 units
Distribution Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Chile, Costa Rica, Deutschland GMBH, Dominican, Ecuador, Hong Kong, Indonesia, Japan, Korea, Paraguay, Philippines, New Zealand, Shanghai, Thailand, and Uruguay.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DWJ and Original Applicant = ARIZANT HEALTHCARE INC.
-
-