Events

Safety Alert for StoneBreaker Pneumatic Lithotripter and associated accessories

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
    2018-03-15
  • Event Date Posted
    2018-03-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180315.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 stonebreaker pneumatic lithotripter and associated accessories medical device manufacturer, cook medical, has issued a medical device safety alert concerning its stonebreaker pneumatic lithotripter and associated accessories. the products are listed below: product brand name: a) stonebreaker pneumatic lithotripter: b) stonebreaker exhaust cap; c) stonebreaker exhaust line; d) stonebreaker probe cap; e) stonebreaker sterilization cap; f) stonebreaker co2 cartridge; g) stonebreaker single use probe. catalog identifier: a) sbl-kit1; b) sba-ec; c) sba-el; d) sba-pc; e) sba-sc; f) sba-10; g) sbp-010500, sbp-010605, sbp-016500, sbp-016605, sbp-020425. lot number: all the manufacturer is initiating a voluntary recall of the affected products, which are intended for reprocessing at the user’s facility. the manufacturer has identified that the interior of the products may not be sterilized to the appropriate sterility assurance level when following the reprocessing instructions provided in the instruction for use (ifu). according to the manufacturer, the potentially adverse events may occur include urinary tract infection, pyelonephritis, and urosepsis. the users are advised to examine inventory immediately to determine if they have affected products and quarantine affected products. products recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of any affected units, please contact your supplier for necessary actions. posted on 15 march 2018.

Device

StoneBreaker Pneumatic Lithotripter and associated accessories
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cook Medical StoneBreaker Pneumatic Lithotripter and associated accessories
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical