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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00422-1
Product Name/Description	Edwards Lifesciences Fem-Flex II Cannulae Model Numbers: FEMII016A, FEMII018A & FEMII020A All Lot Numbers ARTG Number: 177959
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	9/04/2014
Responsible Entity	Edwards Lifesciences Pty Ltd
Reason/Issue	Edwards Lifesciences has received five complaints globally in the last four months involving the separation of dilator tips on specific models of Fem-Flex II arterial cannula sizes 16, 18 and 20 French. Some of the reported events involved separation of the tip of the dilator and required retrieval through an interventional radiologic procedure.
Recall Action	Recall
Recall Action Instructions	Edwards is requesting hospitals to quarantine and return the affected devices immediately.
Contact Information	1800 222 601 - Edwards Lifesciences Customer Service