Events

Recall of Various Vital-Port Vascular Access SystemsVital-Port Vascular Access Systems, Titanium Power Injectable, Single-Chamber SystemsVital-Port Vascular Access System, Standard, Petite and Mini, Titanium and MRI, Single-Chamber SystemsVital-Port Vascular Access System, Standard and Petite Titanium, Dual-Chamber Systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01453-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-11-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01453-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    Cook Medical is advising users to inspect stock and quarantine any remaining units of the affected products for return.

Device

Various Vital-Port Vascular Access SystemsVital-Port Vascular Access Systems, Titanium Power Inje...
  • Model / Serial
    Various Vital-Port Vascular Access SystemsVital-Port Vascular Access Systems, Titanium Power Injectable, Single-Chamber SystemsVital-Port Vascular Access System, Standard, Petite and Mini, Titanium and MRI, Single-Chamber SystemsVital-Port Vascular Access System, Standard and Petite Titanium, Dual-Chamber SystemsMultiple catalogue numbers affectedAll lots are affectedARTG Numbers: 142612, 161948, 145710, 142851
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd