Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00619-1
Product Name/Description	Medrad Hand Controller Sheaths (used with Avanta Pedestal Mount Injection System and Avanta Table Mount Injection System) Catalogue Number: AVA500 HCS All lots with expiry dates prior to March 2018 Batches not affected: D130021, D130221, D130351, D130361, D130491, D130531, D130561, D130571 ARTG Number: 156857
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/07/2013
Responsible Entity	Imaxeon Pty Ltd
Reason/Issue	The manufacturer has become aware of instances where the seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of sterility.
Recall Action	Recall
Recall Action Instructions	Imaxeon isasking users to review inventory and quarantine any affected batches, Affected units are to be returned for a credit.
Contact Information	02 8845 4999 - Imaxeon