Type of Product |
Medical Device |
TGA Recall Reference |
RC-2013-RN-01090-1 |
Product Name/Description |
Inzii 12/15mm Retrieval System (used as a receptacle for the collection and extraction of tissues, organs and calculi during laparoscopic procedures)
Model Number: CD004
Multiple lot numbers affected Manufactured from 20 January 2012 to 21 August 2013 ARTG Number: 139393 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
24/10/2013 |
Responsible Entity |
|
Reason/Issue |
During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Applied Medical is advising users to return affected stock for replacement with unaffected stock. |
Contact Information |
07 3853 2100 - Customer Relations |