Events

Rappel de 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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par William A Cook Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-01453-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-11-29
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01453-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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...
  • Modèle / numéro de série
    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
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd