3M Bair Hugger Warming Blanket Recall for Airflow Occlusion Risk
3M is recalling Bair Hugger warming blankets because a design change may cause airflow blockage, leading to limited inflation during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device where a functional defect (airflow occlusion) poses a risk of harm to patients by failing to prevent or treat hypothermia, but no injuries or illnesses have been reported in the source text.
Plain-English summary
3M Company - Health Care Business is recalling the 3M Bair Hugger Normothermia System, Full Access Underbody Warming Blanket, Models 63500 and 63700. The recall involves 33,108 cases of 5 units each, distributed worldwide including the United States and various international locations.
The recall is due to a design change that can make the blankets more susceptible to unintended occlusion of airflow. This issue may result in limited or partial inflation of the blankets during use, potentially affecting their ability to provide intended thermal management for patients.
The affected lot numbers are R10359, R10360, R10361, R10362, R10363, R10364, R10365, and R10366. Healthcare facilities and users should stop using these specific units and contact 3M for further instructions on replacement or repair.
The recalled product
- 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…
- Manufacturer
- 3M Company - Health Care Business
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 (8)
- Lot Numbers: R10359
- R10360
- R10361
- R10362
- R10363
- R10364
- R10365
- R10366
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.
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