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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01453-1
Product Name/Description	Various Vital-Port Vascular Access Systems Vital-Port Vascular Access Systems, Titanium Power Injectable, Single-Chamber Systems Vital-Port Vascular Access System, Standard, Petite and Mini, Titanium and MRI, Single-Chamber Systems Vital-Port Vascular Access System, Standard and Petite Titanium, Dual-Chamber Systems Multiple catalogue numbers affected All lots are affected ARTG Numbers: 142612, 161948, 145710, 142851
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	29/11/2017
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	During testing of the non-coring needle, Cook Medical have identified that the non-coring needle provided with the Cook Vital-Port Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring needle is inserted into the Vital-Port. This needle is used on the initial implant of the Vital-Port. Vital-Port products that have been successfully placed in patients are not impacted by this recall. There have been no adverse event reports from septum leakage or a silicone sliver pushed into the patient associated with these products to date.
Recall Action	Recall
Recall Action Instructions	Cook Medical is advising users to inspect stock and quarantine any remaining units of the affected products for return. This action has been closed out on 12/02/2019
Contact Information	1800 777 222 - Cook Medical Customer Relations