Events

Rappel de STATLOCK IAB Stabilisation Device (offers needle-free securement for intra-aortic balloon (IAB) catheters)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Maquet 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-00697-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-08
  • 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-00697-1
  • 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 post-quarantine packaging it was identified that the ifu for the statlock sheath stabilisation device for percutaneous sheath introducers was erroneously packaged with the mega and sensation plus iab catheter kits, instead of the ifu for the statlock catheter stabilisation device for iab catheters.
  • Action
    Maquet is advising users to inspect and identify the affected stocks. The IFU from the affected units should be removed and disposed prior to the use of the device. Affected customers can obtain a copy of the correct IFU by visiting the Maquet website at www.Maquet.com/statlockIFU , by scanning the QR code in the customer letter or by contacting the customer's local Maquet representative. This action has been closed-out on 11/05/2017.

Device

STATLOCK IAB Stabilisation Device (offers needle-free securement for intra-aortic balloon (IAB) c...
  • Modèle / numéro de série
    STATLOCK IAB Stabilisation Device (offers needle-free securement for intra-aortic balloon (IAB) catheters)Macquet Part Number: 0065-00-0704Products affectedAll lot numbers from 3000001484 to 3000024495ARTG Number: 139645
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA