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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 Applied Medical Australia Pty Ltd
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