Events

Recall of KWIK-STIK 939P - ACTINOMYCES ODONTOLYTICUS

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

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
    109019
  • Event Risk Class
    III
  • Event Initiated Date
    2017-03-01
  • 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
    The product is being recalled because it is mislabelled. the actual organism contained with the product is eggerthella lenta. it is supposed to contain actinomyces odontolyticus.

Device

KWIK-STIK 939P - ACTINOMYCES ODONTOLYTICUS
  • Model / Serial
    Model Catalog: 0939P (Lot serial: 939-47-2)
  • Product Description
    KWIK-STIK 939P - Actinomyces odontolyticus
  • Manufacturer
    MICROBIOLOGICS INC.

Manufacturer

MICROBIOLOGICS INC.