Events

Safety Alert for Roadrunner Uniglide Hydrophilic Wire Guide

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
    2016-07-07
  • Event Date Posted
    2016-07-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160707b.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 roadrunner uniglide hydrophilic wire guide health canada has posted a medical device safety alert concerning roadrunner uniglide hydrophilic wire guide [model number: hpw-35-150, hpwa-35-180, hpwas-35-180], manufactured by cook medical. the manufacturer is initiating a voluntary recall because of a potential coating contamination. the supplier of the coating, dsm biomedical b.V., has recalled some of its coating material because of concerns about potential component contamination with glass particles. the reported glass particle size ranged from approximately 4 to 280 micrometre. for details, please refer to the health canada website: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2016/59208r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 july 2016.

Device

Roadrunner Uniglide Hydrophilic Wire Guide
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Medical Device Safety Alert: Cook Medical Roadrunner Uniglide Hydrophilic Wire Guide
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical