Print version of this report
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 St Jude Medical Australia Pty Ltd
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