Events

Rappel de Chorion Villus Biopsy Needle Set

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-2018-RN-00835-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-06-26
  • 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-2018-RN-00835-1
  • 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 identified the diagram on the product label of the chorion villus biopsy needle set (k-cvns-1821-robinson-et) is incorrect. it shows that the 18ga needle has an echotip, and the 21ga needle does not, whereas the product is designed such that the 21ga needle has the echotip and the 18ga needle does not.The tip of the larger gauge guide needle is likely to be visible on the ultrasound regardless of a non-echogenic tip. in the event that the labelling error resulted in a clinician expecting the echogenic tip to be present on the guide needle, instead of the sampling needle, the clinician may not be able to adequately identify the tip of the inserted access needle.To date, there have been no reports of harm relating to this issue.
  • Action
    William A Cook is advising customers to inspect stock and return affected product.

Device

Chorion Villus Biopsy Needle Set
  • Modèle / numéro de série
    Chorion Villus Biopsy Needle SetCatalogue Identifier: K-CVNS-1821-ROBINSON-ETOrder Number: G26661All lots manufactured up to 4 June 2018ARTG Number: 138806(William A Cook Australia Pty Ltd - Chorionic Villi Biopsy Needle Set - Needle, biopsy, single use)
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd