FDA Device recall Z-0598-2018
3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is…
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is… by 3m Health Care Business, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0598-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-23 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | 3m Health Care Business |
| Distribution | US |
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.
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.
Identifiers
| code_info | Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0598-2018%22
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