Events

Safety Alert for SURE-T, SURE-T Paradigm, contact detach, contact, Sub Q, neria, neria detach, neria multi, thalaset

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

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
    2015-05-28
  • Event Date Posted
    2015-05-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150528.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: unomedical sure-t, sure-t paradigm, contact detach, contact, sub q, neria, neria detach, neria multi, thalaset medicines and healthcare products regulatory agency (mhra), united kingdom, has posted a medical device safety alert concerning sure-t, sure-t paradigm, contact detach, contact, sub q, neria, neria detach, neria multi, thalaset, manufactured by unomedical. the manufacturer has found that in rare cases the steel needle can break during use. this can lead to leakage of medication, and the needle may require surgical removal. for details, please refer to the following mhra website:https://mhra.Filecamp.Com/public/files/28sw-b47gpk8c#/public/file/28tm-u2s8e8p1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 may 2015.

Device

SURE-T, SURE-T Paradigm, contact detach, contact, Sub Q, neria, neria detach, neria multi, thalaset
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Unomedical SURE-T, SURE-T Paradigm, contact detach, contact, Sub Q, neria, neria detach, neria multi, thalaset
  • Manufacturer
    Unomedical

Manufacturer

Unomedical