Events

Rappel de ARROW PICC Kits with Peel-Away Sheath Component

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-2017-RN-00408-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-04-05
  • 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-00408-1
  • 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
    Arrow international has received complaints related to peel away sheath flare for the arrow picc kits. the instructions for use included with the kits do not inform the user that a skin nick or alternate enlargement method may be required for difficult insertions. the use of a skin nick reduces the possibility of sheath flare and subsequent complications. there is a remote possibility the device may cause a delay in treatment or minor damage to the vessel wall or subcutaneous tissue.
  • Action
    Teleflex is advising users that they may be required to use an alternate enlargement method or perform a skin nick for difficult insertions. Customers are also requested to include the supplementary card (Product Notice) with their affected stock.

Device

ARROW PICC Kits with Peel-Away Sheath Component
  • Modèle / numéro de série
    ARROW PICC Kits with Peel-Away Sheath ComponentCatalogue Numbers: PI-01351-LS, PI-01351-SS, PI-01451-LS, PI-01451-SS, PI-01552-LS, PI-01552-SS, PR-05041, PR-05041-T, PR-05042, PR-05052, PR-05052-MWMultiple Lot NumbersARTG Numbers: 148783 and 148784
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd