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Altrus Thermal Tissue Fusion System - Handpiece (2014-02-28)
- Starting date:
- February 28, 2014
- Posting date:
- March 25, 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-38595
Recalled Products
Altrus Thermal Tissue Fusion System - Handpiece
Reason
Conmed Canada is sending this reminder to provide important information concerning the proper use of Altrus thermal tissue fusion handpiece. The reason for this notification is to reinforce best practices when using energy devices.
Energy based vessel sealing devices are vital in the continued improvement in surgical approaches. As with all energy based technologies, there are risks. It is important to follow the defined instructions for use when handling these devices after they are activated. Use caution and best practices as these devices generate heat. Ensure the jaws of your energy based vessel sealing devices are not in contact with unintended tissue, surfaces, or objects until the jaws have cooled sufficiently. If the jaws are still hot, there is a risk that a patient could be unintentionally burned if they have not cooled sufficiently. Always refer to a device's operator's manual and instructions for use for proper use and warnings.
Affected products
Altrus Thermal Tissue Fusion System - Handpiece
Lot or serial number
60-9510-001
60-9511-001
60-9512-001
60-9520-001
60-9521-001
60-9522-001
Model or catalog number
All lots
Companies
- Manufacturer
-
Conmed Corporation
525 French Road
Utica
13502
New York
UNITED STATES