Safety Alert for Custom Dialysis Trays/Kits

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

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
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Fda class i recall: lee medical international inc., custom dialysis trays/kits u.S. food and drug administration (fda) has issued a class i recall concerning custom dialysis trays/kits manufactured by lee medical international inc. the custom dialysis kits are designed to include all the components (gloves, bandages, fistula needles, antibacterial pads [povidone iodine (pvp) prep pads], and specific bloodlines) used in preparing hemodialysis vascular access sites for patients undergoing dialysis procedures. the pvp prep pads were recalled by h & p industries because the pads may not be sterile. patients receiving hemodialysis who use the pads may be at potential risk for serious or life threatening infection. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/ucm272167.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.