Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01088-1
Product Name/Description	OPTEASE Retrievable Vena Cava Filter Product Code: 466F210A & 466F210B All lots below lot number 15960131 ARTG Number: 165592, 186230
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	22/10/2013
Responsible Entity	Johnson & Johnson Medical Pty Ltd
Reason/Issue	A printing error has been identified on one unit of OPTEASE Retrievable Vena Cava Filter. The orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in the filter being implanted upside down, requiring an additional percutaneous procedure to retrieve the filter. All lots of the Cordis OPTEASE Retrievable Vena Cava Filter are being removed, since it cannot be absolutely determined that no other similar printing errors occurred.
Recall Action	Recall
Recall Action Instructions	Customers are requested to quarantine the affected product prior to returning to JJM.
Contact Information	1800 252 194 - Johnson & Johnson Medical Customer Service