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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01139-1
Product Name/Description	Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage) Catalogue Number: 951303 Lot Number: 0195786 ARTG Number: 172182
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	29/08/2016
Responsible Entity	Integra Neurosciences Pty Ltd
Reason/Issue	The manufacturer has identified that there is a possibility of an incomplete seal of the product packaging in one specific lot of the Ventricular Catheter Accessory Kit. The packaging defect can impact both the inner and outer seals of the product resulting in the possibility that the sterility assurance may be compromised. To date, there have been no complaints submitted and no adverse events reported due to a compromised seal.
Recall Action	Recall
Recall Action Instructions	Integra is advising users to inspect inventory and quarantine any remaining units of the affected stock. Affected product will be replaced with unaffected stock. This action has been closed-out on 16/02/2017.
Contact Information	1300 550 599 - Integra Customer Service