Events

Recall of GLUMA COMFORT BOND + DESENSITIZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by KULZER LLC.

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
    30650
  • Event Risk Class
    III
  • Event Initiated Date
    2007-08-16
  • 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
    Material in bottle may solidify and cannot be dispensed. there are no health risks with using the product because once solidified it will not dispense. in its liquid state product is safe and effective.

Device

GLUMA COMFORT BOND + DESENSITIZER
  • Model / Serial
    Model Catalog: 66001710 (Lot serial: 010065); Model Catalog: 66018222 (Lot serial: 010065)
  • Product Description
    Gluma Comfort Bond and Desensitizer
  • Manufacturer
    KULZER LLC

Manufacturer

KULZER LLC
  • Manufacturer Address
    SOUTH BEND
  • Source
    HC