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Health product recall

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