Events

Rappel de Transseptal Needle

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-01503-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-12-13
  • 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-01503-1
  • 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
    Cook medical has become aware that certain transseptal needles may be the incorrect length, and is initiating a recall of lot 8181945. potential adverse events may occur by using the nonconforming products, including being unable to perform the transseptal puncture. this could necessitate replacing the device or rescheduling the procedure. in addition, use of the nonconforming products could make the puncture less controlled, which could potentially lead to injury of the heart.
  • Action
    Cook Medical is advising customers to quarantine affected stock from their inventory for return to the sponsor for a product credit as per the instructions given in the customer letter.

Device

Transseptal Needle
  • Modèle / numéro de série
    Transseptal NeedleLot Number: 8181945Reference Part Number: TSNC-18-71.0Global Part Number: G02364ARTG 155227
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd