Events

Rappel de ARROW OnControl System Trays ARROW OnControl Bone Lesion Biopsy System Tray ARROW OnControl Bone Marrow Biopsy System Tray ARROW OnControl System Sterile Procedure Tray

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Teleflex Medical 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-2016-RN-01494-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-14
  • 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-2016-RN-01494-1
  • 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
    Teleflex has identified an issue where there is the potential for an incomplete seal on the outer sterile package. because of the compromised packaging, the sterility of the inside drape, which is used in preparation for bone marrow aspiration with the oncontrol system, cannot be guaranteed. if sterility of the drape is compromised, there is the potential for infection to occur.
  • Action
    Customers are advised not to use or further distribute any affected stock. Teleflex Medical will arrange collection of the stock under quarantine and a credit to be applied to the customer's account.

Device

ARROW OnControl System Trays ARROW OnControl Bone Lesion Biopsy System Tray ARROW OnControl Bone ...
  • Modèle / numéro de série
    ARROW OnControl System TraysARROW OnControl Bone Lesion Biopsy System TrayARROW OnControl Bone Marrow Biopsy System TrayARROW OnControl System Sterile Procedure TrayCatalogue Numbers: 9403-EU-006, 9408-EU-006, 9411-EU-006, 9462-EU-001, 9463-EU-001, 9464-EU-001, 9466-EU-001Multiple Batch NumbersARTG Number: 264374
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd