Type of Product |
Medical Device |
TGA Recall Reference |
RC-2012-RN-00855-3 |
Product Name/Description |
Syntel Vascular Catheters and Syntel Biliary Catheters (embolectomy catheter)
Syntel Vascular Catheters Model Numbers: A4403, A4405 to A4407 (inc), A4F00 to A4F08 (inc.) Lot Numbers: Multiple lots affected ARTG Number: 116754
Syntel Biliary Catheters Model numbers: A4752 Lot numbers: 1165670 ARTG Number: 116815
|
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
28/08/2012 |
Responsible Entity |
|
Reason/Issue |
Potential for packaging particulate matter to reside on the product. |
Recall Action |
Recall |
Recall Action Instructions |
Quarantine and return recalled lots to Applied Medical. |
Contact Information |
07 3853 2100 - Applied Medical Australia, Customer Relations |