Events

Rappel de Cook Beacon Tip Angiography Catheters Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, Beacon Tip Catheters, Shuttle Select Slip-Cath, 4 FR Shuttle System Compatible

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-2016-RN-00021-2
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-01-06
  • 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-00021-2
  • 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 is initiating a recall of all lots in distribution following reports of catheter tip splits and/or separation. potential adverse events that may occur as a result of catheter tip splitting and or separation may include the loss of device function, medical intervention to retrieve the separated segment, or complications resulting from the separated tip occluding blood flow to end organs.
  • Action
    Cook Medical is advising users to inspect and quarantine any affected lots for return to Cook Medical.

Device

Cook Beacon Tip Angiography Catheters Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal ...
  • Modèle / numéro de série
    Cook Beacon Tip Angiography CathetersBeacon Tip Torcon NB Advantage CathetersCatalogue Prefix: HNBR4.0, HNBR4.1 and only HNBR5.0 w/RUC SuffixBeacon Tip Royal Flush Plus High-Flow CathetersCatalogue Prefix: HNR4.0Slip-Cath Beacon Tip CathetersCatalogue Prefix: SCBR4.0, SCBR4.1, and only SCBR5.0 w/RUC SuffixShuttle Select Slip-Cath, 4 FR Shuttle System CompatibleCatalogue Prefix: SCBR4.5All Lot Numbers affectedARTG Numbers: 137861, 154909, 154911, 137865
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd