Devices

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

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

One device with a similar name

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

Model / Serial
Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366
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, 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.
Manufacturer
3M Company - Health Care Business

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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