Events

Recall of GLUMA DESENSITIZER POWERGEL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by FIRST SERVICE DENTAL SUPPLY CORP..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    105924
  • Event Risk Class
    II
  • Event Initiated Date
    2016-09-08
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    As the result of a complaint to heraeus kulzer's technical service department we discovered that gluma desensitizer powergel has an issue with inadvertent expulsion of the gel.

Device

GLUMA DESENSITIZER POWERGEL
  • Model / Serial
    Model Catalog: 66043451 (Lot serial: n/a); Model Catalog: 66043451 (Lot serial: 48)
  • Product Description
    Gluma Desensitizer powergel
  • Manufacturer
    FIRST SERVICE DENTAL SUPPLY CORP.

Manufacturer

FIRST SERVICE DENTAL SUPPLY CORP.