Events

Safety Alert for Premise Universal Restorative Body Syringe and Unidose, Shade A2

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

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
    2014-09-12
  • Event Date Posted
    2014-09-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140912.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: kerr premise universal restorative body syringe and unidose, shade a2 medical device manufacturer, kerr corporation, has issued a medical device safety alert concerning its premise universal restorative body syringe and unidose, shade a2, with the following details: product descriptions: a) refill - syringe premise a2; and b) refill - unidose premise a2 part no.: a)32618; b) 32651 serial no.: a) 4941320; 4946443; 4906963; b) 4908202; 4890805; 4890804; 4890806; 4946447 shipped between june 2013 to november 2013 the manufacturer received some complaints that certain units within certain lots of premise a2 composite may be sticky and/or difficult to use. there is no safety issue associated with using the product. affected users should review to determine if they have any of the affected products in their inventory, and users can choose to return the affected product for replacement if not satisfied. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 sep 2014.

Device

Premise Universal Restorative Body Syringe and Unidose, Shade A2
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Kerr Premise Universal Restorative Body Syringe and Unidose, Shade A2
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation