Events

Safety Alert for Ultraxx Nephrostomy Balloon Set and Ascend AQ Ureteral Dilation Balloon 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
    2016-02-03
  • Event Date Posted
    2016-02-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160203.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 ultraxx nephrostomy balloon set and ascend aq ureteral dilation balloon catheter set medical device manufacturer, cook medical, has issued a medical device safety alert concerning its ultraxx nephrostomy balloon set and the ascend aq ureteral dilation balloon catheter set [catalogue number: unbs-10-15-cs (lot number: 5082013) and aubs-6-4 (lot number: 5083854)]. the affected products were distributed between 22 july 2014 and 6 august 2014. the manufacturer has received reports of packages labeled as ultraxx nephrostomy balloon set actually containing the ascend aq ureteral dilation balloon catheter set and vice versa. according to the manufacturer, this event is not likely to lead to an adverse patient/user outcome and is obvious to the user. this nonconformity is detectable, making it less likely that an incorrect device would be used or misused during a procedure. product recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 february 2016.

Device

Ultraxx Nephrostomy Balloon Set and Ascend AQ Ureteral Dilation Balloon Catheter Set
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cook Medical Ultraxx Nephrostomy Balloon Set and Ascend AQ Ureteral Dilation Balloon Catheter Set
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical