| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00113-1 |
| Product Name/Description |
Super Arrow-Flex Percutaneous Sheath Introducer Set
SAP/Catalogue Numbers: CL-07635, CL-07735 and CL-07835
Multiple batch numbers affected
ARTG Number: 135922 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
The reason for this action is due to potential packaging damage where the outer packaging may exhibit scratches or pin holes. Therefore, the sterility of the product cannot be guaranteed. If a non-sterile product is used, there is potential for infection to occur.
No patient injuries have been reported related to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Teleflex is advising users to quarantine any affected stock for return to Teleflex. A credit note will be issued for stock returned. This action has been closed-out on 25/01/2017. |
| Contact Information |
1300 360 226 - Teleflex Medical Australia Customer Service |