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Arctic Sun Temperature Management System
- Starting date:
- October 18, 2016
- Posting date:
- November 15, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61024
Affected Products
Reason
Bard is informing customers of an additional warning added to the Medivance, Inc. Arctic Sun Temperature Management System Operator's manual, that the device is not intended for use in the operating room environment. This is to mitigate the potential for infection caused by nontuberculous mycobacterium (NTM).
Affected products
Arctic Sun Temperature Management System
Lot or serial number
All serial numbers
Model or catalog number
5000-00-00
Companies
- Manufacturer
-
Medivance, Inc.
321 South Taylor avenue, Suite 200
Louisville
80027
Colorado
UNITED STATES