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Recall Observatory FDA recall evidence

Device 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.

Z-0598-2018

January 23, 2018

Class II

Product summary

Firm
3M Company - Health Care Business
Event
Event 79002
Status
Terminated
Classification
Class II
Quantity
33108 cases of 5 units
Official record key
device-enforcement:Z-0598-2018

Official wording

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.

Code information: Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.