Events

Rappel de Cook Bush SL and Bush DL Ureteral Illuminating Catheters(used for trans-illumination of the ureters during laparoscopic or open surgical procedures)

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-00365-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-10
  • 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-00365-1
  • 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
    There has been an increase in reports that the proximal black component that connects to the distal transparent component of the catheter may overheat and melt. there have been no reports of overheating along the transparent component of the catheter, which is the part of the device that comes into contact with the patient’s urethra, bladder and ureter. potential adverse events that may occur if these devices overheat and come into direct contact with skin include burns to the skin.
  • Action
    Customers are advised to quarantine and immediately return any affected product that remains unused to Cook Medical.

Device

Cook Bush SL and Bush DL Ureteral Illuminating Catheters(used for trans-illumination of the urete...
  • Modèle / numéro de série
    Cook Bush SL and Bush DL Ureteral Illuminating Catheters(used for trans-illumination of the ureters during laparoscopic or open surgical procedures)Cook Bush SL Ureteral Illuminating Catheter Set Catalogue Numbers: 084100, 084120 , J-BICS-058020Part Numbers: G16745, G16746, G16737All LotsCook Bush DL Ureteral Illuminating Catheter Set Catalogue Numbers: 084520, 084510, J-BICS-078000Part Numbers: G16747, G16143, G16262All LotsARTG Number: 215910
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd