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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00484-1
Product Name/Description	Disposable StrykeFlow Tip (electrosurgical suction tip) Item Number: 250-070-505 Affected Lots: 14021FG2, 13337FG2, 13343FG2, 13347FG2, 14007FG2, 14016FG2 ARTG Number: 142786
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/06/2015
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	An internal review concluded that 6 lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch, which could potentially impact the sterility of the product. Although to date there have been no reported events of infection to Stryker as a result of using potentially affected product, there is a remote possibility for infection due to usage of a non-sterile product.
Recall Action	Recall
Recall Action Instructions	Customers are asked to check any affected items in their possession and quarantine any affected units immediately. A Stryker Representative will coordinate an inspection of the affected items in quarantine. Any affected items will be removed by the Stryker Representative. This action has been closed-out on 2/06/2016.
Contact Information	1800 803 601 RAQA Co-ordinator