The Recall Desk
HighFDA (Devices)·Z-0599-2018·Announced 2018-02-21

3M Bair Hugger Underbody Blanket Recall for Airflow Occlusion Risk

3M is recalling Bair Hugger Normothermia System blankets due to a design change that may cause unintended airflow occlusion and limited inflation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

3M Company - Health Care Business is recalling the 3M Bair Hugger Normothermia System, Sterile Full Access Underbody, Model 63700. The recall involves 36 cases of 5 units, specifically Lot Number FR10361. The product is intended to prevent and treat hypothermia and provide thermal comfort for adult and pediatric patients.

The recall is being issued because a design change to the 3M Bair Hugger Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow. This defect may result in limited or partial inflation of the blanket during use.

The affected units were distributed worldwide, including nationwide in the US and in Australia, Canada, Chile, Costa Rica, Germany, Dominican Republic, Ecuador, Hong Kong, Indonesia, Japan, Korea, Paraguay, Philippines, New Zealand, Shanghai, Thailand, and Uruguay. Users should stop using the affected blankets and contact 3M for instructions on replacement or return.

The recalled product

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
Manufacturer
3M Company - Health Care Business
Category
Medical Device — Patient Warming System
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: FR10361

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by 3M Company - Health Care Business under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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