This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Arctic Sun 5000 Temperature Management System
- Starting date:
- August 25, 2017
- Posting date:
- September 11, 2017
- 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-64502
Reason
Bard is informing customers that use of the Arctic Sun Temperature Management System in excess of 2,000 system hours, without conducting preventative maintenance, may result in failure of certain components of the system, particularly in relation to the mixing pump, which runs continuously during operation. Failure of the mixing pump may cause the device to cease to function as intended, resulting in no availability of cooling or rewarming therapy for the patient.
Affected products
Arctic Sun 5000 Temperature Management System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
5000-00-00
Companies
- Manufacturer
-
Medivance, Inc.
321 South Taylor avenue, Suite 200
Louisville
80027
Colorado
UNITED STATES