Events

Safety Alert for Cook Bush SL Ureteral Illuminating Catheter Set and Cook Bush DL Ureteral Illuminating Catheter Set

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Cook Medical.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-03-08
  • Event Date Posted
    2017-03-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170308.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: cook medical cook bush sl ureteral illuminating catheter set and cook bush dl ureteral illuminating catheter set medical device manufacturer, cook medical, has issued a medical device safety alert concerning its cook bush sl ureteral illuminating catheter set and cook bush dl ureteral illuminating catheter set as below: cook bush sl ureteral illuminating catheter set catalog identifier (part number): 084100 (g16745), 084120 (g16746) and j-bics-058020 (g16737) cook bush dl ureteral illuminating catheter set catalog identifier (part number): 084520 (g16747), 084510 (g16143) and j-bics-078000 (g16262) the manufacturer is initiating a voluntary recall of all lot numbers of the affected products. they have received an increased number of reports where 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. according to the manufacturer, potential adverse events that may occur if these devices overheat and come into direct contact with skin include burns to the skin. the manufacturer advises users to examine inventory immediately to determine if they have the affected products. the affected products should be quarantined and returned to the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 8 march 2017.

Device

Cook Bush SL Ureteral Illuminating Catheter Set and Cook Bush DL Ureteral Illuminating Catheter Set
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cook Medical Cook Bush SL Ureteral Illuminating Catheter Set and Cook Bush DL Ureteral Illuminating Catheter Set
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical