Health product recall

Arctic Sun 5000e Temperature Management System (2018-06-13)

Starting date:
June 13, 2018
Posting date:
June 22, 2018
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-67096

Affected products

Arctic Sun 5000e Temperature Management System

Reason

To inform customers of a voluntary field correction on all ARCTIC SUN 5000 Temperature Management Systems. An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system. Bard will conduct repairs of this wiring connection either on-site or at an authorized service depot

Affected products

Arctic Sun 5000e 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

UNITED STATES