Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-01079-1 |
Product Name/Description |
Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators
Catalogue number: 1517079
Multiple lot numbers
ARTG number: 146847 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
9/10/2014 |
Responsible Entity |
|
Reason/Issue |
Integra NeuroSciences has identified through an investigation of complaints that some specific lots of SELECTOR® Tubing Kits may potentially leak irrigation fluid during use if not placed on the SELECTOR handpiece in a specific manner. If the lumens of the 2 tubes are not separated before placing them on the handpiece barbs, this could result in an irrigation fluid leak. If the leakage is significant, the handpiece tip could overheat and possibly burn tissue being treated. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Integra is providing additional instructions to prevent the occurrence of leakage. This action has been closed-out on 03/06/2016. |
Contact Information |
1300 550 599 - Integra Customer Service |