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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00675-1
Product Name/Description	Edwards Lifesciences Suction Wand (Used during cardiac surgery for the suction of excessive fluid from the pericardium) Model code: S099 All lot numbers ARTG number: 154578
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	2/07/2013
Responsible Entity	Edwards Lifesciences Pty Ltd
Reason/Issue	During inspection of some distributed rigid suction wands (model S099), Edwards discovered plastic particulate inside the sterile pouch and within the internal diameter of the rigid suction wands. The particulate ranged from 0.26 to 0.41 (6.6 to 10.4mm) in size. Particulate not detected during the preparation of the device may pose a risk as it may enter into the pericardium and could cause abrasions to the surface of the heart.
Recall Action	Recall
Recall Action Instructions	Customers are asked to quarantine the affected product from inventory and return all affected stock with remaining shelf life to Edwards. Customers are asked to contact Edwards customer service or sales representative about alternative suction wand product's availability.
Contact Information	1800 222 601 - Edwards Customer Service