3M Company - Health Care Business: 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.

Agency Publication Date: February 12, 2018

Affected Products

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.

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

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Product: 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.

Lot Numbers: FR10361

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79002

Status: Resolved

Manufacturer: 3M Company - Health Care Business

Manufactured In: United States

Units Affected: 2 products (33108 cases of 5 units; 36 cases of 5 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

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

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Lot Numbers: FR10361

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