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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