Events

Recall of Device Recall 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 3M Company - Health Care Business.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79002
  • Event Risk Class
    Class 2
  • Event Number
    Z-0599-2018
  • Event Initiated Date
    2018-01-23
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161065
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, thermal regulating - Product Code DWJ
  • Reason
    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.
  • 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.

Device

Device Recall 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket
  • Model / Serial
    Lot Numbers: FR10361
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 || 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.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • Manufacturer Address
    3M Company - Health Care Business, 3m Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144-0001
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    USFDA