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Arctic Sun Temp Management System, 2000 and 5000 (2014-08-28)

Starting date:
August 28, 2014
Posting date:
September 9, 2014
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-41293

Recalled Products   

A) Arctic Sun Temp Management System, 2000
B) Arctic Sun Temp Management System, 5000

Reason

This recall is being initiated by Bard Canada in order to inform users of a safety concern while using temperature simulator keys with the Arctic Sun Temp Management System. Two adverse events have been reported to Bard Medical Division. In each instance, a temperature simulator key (Product code 748-00 and as part of service kit 771-00) was connected to the patient cable instead of the patient temperature probe. Due to the false patient temperature reading from the temperature simulator key, improper targeted temperature therapy was delivered to the patients.

Affected products

A) Arctic Sun Temp Management System, 2000
 

Lot or serial number

All serial numbers.      

Model or catalog number

2000-02

Companies
Manufacturer
Medivance, Inc.
321 South Taylor avenue, Suite 200
Louisville
80027
Colorado
UNITED STATES

B) Arctic Sun Temp Management System, 5000

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