Events

Rappel de Figulla Flex II ASD, Figulla Flex II PFO and Occlutech PDA Occluder Cardiac Occluders

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Getz Healthcare 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-00147-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-03
  • 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-00147-1
  • 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
    Occlutech has received a report whereby a customer inadvertently used an expired occlutech flex ii pusher cable and noticed doing so shortly after the implantation procedure. there was no impact on the patient, the procedure or the product performance. occlutech occluders and compatible pusher cables are packaged together into an occlutech product set which also contains the instructions for use and the patient information card. the outer label on the occlutech product set clearly shows the expiration dates of both the occluder and the pusher cable. as these dates can differ from each other, it is important to check both dates to not miss the shortest expiration date.
  • Action
    Occlutech will in future be implementing a revised Occlutech product set label showing only the shortest expiry date. For current inventory, Getz Healthcare is advising customers to immediately check the expiration dates of the Occlutech Occluder and of the pusher cable as printed on the outer box-label of all products in their current inventory. If one of the expiration dates is exceeded, customers are to block and remove the Occlutech Occluder set containing the expired product from their inventory. Getz will replace all expired stock. End-users are also advised to carefully routinely review the Occutech Occluder set labels prior to use, in accordance the Instructions for Use. This action has been closed-out on 01/03/2018.

Device

Figulla Flex II ASD, Figulla Flex II PFO and Occlutech PDA Occluder Cardiac Occluders
  • Modèle / numéro de série
    Figulla Flex II ASD, Figulla Flex II PFO and Occlutech PDA Occluder Cardiac OccludersFigulla Flex II ASDProduct Code: 29ASDxx Figulla Flex II PFOProduct Code: 19PFOxxD Occlutech PDA OccluderProduct Codes: 42PDAxx, 42PDAxxL, 43PDAxxLMultiple Lot NumbersARTG Numbers: 201602, 201603, 219523
  • Manufacturer
    Getz Healthcare Pty Ltd

Manufacturer

Getz Healthcare Pty Ltd