| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00358-1 |
| Product Name/Description |
The ARROWg+ard Blue PLUS antimicrobial catheter
Multiple Lot Numbers
ARTG Numbers: 138302, 136923, 278735, 278926 and 279697 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that certain product may have packaging that is not sealed.
In the event the packaging is compromised in this manner, sterility of the product cannot be guaranteed. If a non-sterile product is used, there is potential for an infection to occur.
To date, Teleflex Medical has not received reports of this issue in Australia. |
| Recall Action |
Recall |
| Recall Action Instructions |
Teleflex is advising customers to inspect inventory for impacted lots and identify any units that appear to be affected. These units should then be discarded and Teleflex will provide a suitable credit following receipt of the acknowledgement form suppled with the customer letter.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1300 360 226 - Teleflex Medical Customer Service |