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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00473-1
Product Name/Description	Percutaneous Sheath Introducer Kits Batch numbers AK09903A - 23F13G0162 SI09903E – RF3064915, RF3064710 ARTG Number: 135922
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	28/04/2014
Responsible Entity	Mayo Healthcare Pty Ltd
Reason/Issue	The manufacturer has initiated this recall due to tip damage noticed during internal inspection of the dilator tip of the Percutaneous Sheath Introducer found in the above referenced kits. Tip damage has the potential to result in vessel damage.
Recall Action	Recall
Recall Action Instructions	Mayo Healthcare is requesting end users to inspect their stock and quarantine any units from the affected batches. Mayo Healthcare will contact customers to arrange for the recovery of affected devices.
Contact Information	1300 360 226 - Mayo Healthcare National Customer Service