| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01053-1 |
| Product Name/Description |
Encore 26 Advantage Kit & Encore 26 Advantage Kit, 5 pack (Used to perform general intravascular procedures)
Encore 26 Advantage Kit
Material Number: H74904527011
Catalogue Number: 04527-01
Encore 26 Advantage Kit (5 pack)
Material Number: H74904527052
Catalogue Number: 04527-05
Multiple Lot Numbers
Expiration dates between 13 August 2014 & 30 September 2014
Manufactured between 3 August 2012 & 18 September 2012
ARTG Number: 159833 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
Users of the Encore 26 Advantage Kits which were manufactured between August 3 2012 and September 18 2012 may experience difficulty in passing guidewires through the insertion tool which is included in the Encore 26 Advantage Kits. The difficulty to pass guidewires, especially J tipped guidewires, through the insertion tool is caused by lack of smoothness within the hub/hypo tube transition in some devices. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is provided work around instructions for users to follow. |
| Contact Information |
02 8063 8340 - Boston Scientific |