Events

Rappel de Disposable Reuter Tip-Deflecting Wire Guide

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-01390-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-08
  • 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-2017-RN-01390-1
  • 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 that the labels of specific lots of disposable reuter tip-deflecting wire guides do not explicitly state that they are heparin coated. the products are labelled with the correct catalogue identifier, which includes the suffix “bh” that indicates the product is heparin coated. however, users who are not familiar with the “bh” nomenclature may not be aware that the product contains heparin.To date, no adverse events have been reported due to this issue. under rare circumstances, these products could unknowingly be used in a patient with a heparin allergy or a patient with a history of heparin induced thrombocytopenia (hit). either of these situations could potentially result in serious injury or death.
  • Action
    Cook Medical is advising users to inspect stock and quarantine remaining units for replacement with unaffected stock.

Device

Disposable Reuter Tip-Deflecting Wire Guide
  • Modèle / numéro de série
    Disposable Reuter Tip-Deflecting Wire GuideCatalogue Identifier (Prefix/Suffix): DTDW-/-BHLot Numbers: F4791428, F4791430, NS5562947 and F4791427Supplied under Special Access Scheme (SAS)
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd