Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00365-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00365-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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...
  • Model / Serial
    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