| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01169-1 |
| Product Name/Description |
MEDRAD Avanta Hand Controller Sheath (multi-phase contrast medium injection system)
Expiration dates prior to April 2017
ARTG Number: 156857 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
The TYVEK to plastic seal may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this product accessory. |
| Recall Action |
Recall |
| Recall Action Instructions |
Imaxeon is asking customers to inspect the stock following instructions provided as part of the customer letter or return all potentially affected stock and receive a credit note. |
| Contact Information |
02 8845 4999 - Customer Support Team |