| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00609-1 |
| Product Name/Description |
AGA Medical Amplatzer Septal Occluder
Amplatzer Septal Occluder, 28mm
Catalogue Number: 9-ASD-028
Batch Number: 4433612
ARTG Number: 134067 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
The product and product label on the inner pouch do not match the outer product label. The product listed on the inner pouch is correct. Use of the affected unit may result in a procedural delay while another occluder of the desired size is obtained. |
| Recall Action |
Recall |
| Recall Action Instructions |
St. Jude Medical sales representative will contact customers to facilitate removal of the affected product and for providing replacement or issuance of full credit for the removed product. |
| Contact Information |
02 9936 1200 - St Jude Medical Australia |