Z-0598-2018 Class II Terminated
FDA device recall Z-0598-2018 was initiated by 3M Company - Health Care Business on Jan 23, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Aug 21, 2020). Affected quantity: 33108 cases of 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 21, 2018
- Initiation Date
- Jan 23, 2018
- Termination Date
- Aug 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33108 cases of 5 units
Product Description
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 for Recall
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.
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.
Code Information
Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0598-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026