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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00376-1
Product Name/Description	Sapheon (Covidien) VenaSeal Closure System Lot Numbers: 37399, Mnf date: 07/08/2014, Exp date: 2016-5 37621, Mnf date: 28/07/2014, Exp date: 2016-3 38407, Mnf date: 16/10/2014, Exp date: 2016-5 37417, Mnf date: 16/10/2014, Exp date: 2016-7 38756, Mnf date: 07/11/2014, Exp date: 2016-7 38863, Mnf date: 20/11/2014, Exp date: 2016-9 ARTG Number: 194201
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	6/05/2015
Responsible Entity	Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue	There is the potential for a sterility breach of the outer packaging (pouch) material. A breach of the outer pouch may compromise the outside surface sterility of the sealed inner tray and does not directly affect the sterility of the device components This potential for a sterile breach in the outer pouch material was discovered during standard internal packaging tests. The breach in the pouch barrier may not be detectable by visual inspection of the product. Medtronic has identified possible causes for the pouch damage and has taken actions to prevent distribution of product that may be affected by this issue.
Recall Action	Recall
Recall Action Instructions	Customers are asked to review their inventory, quarantine product, complete the customer confirmation certificate and return all unused product to Medtronic. This action ha been closed-out on 10/08/2016.
Contact Information	02 9006 1662 - Emergo Australia