Medical device manufacturer, Applied Medical, has issued a medical device safety alert concerning Inzii 12/15mm retrieval system. The affected model number is CD004 with multiple lot numbers affected.
The manufacturer is conducting a voluntary recall of the Inzii 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier.
The manufacturer is advising users to return affected stock for replacement with unaffected stock.
According to the local supplier, the affected products were NOT distributed in Hong Kong.
For more details, please refer to Therapeutic Goods Administration website
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01090-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 October 2013