Events

Recall of CONSEPSIS INDISPENSE SYRINGE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CLINICAL RESEARCH DENTAL SUPPLIES AND SERVICES 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
    20577
  • Event Risk Class
    III
  • Event Initiated Date
    2017-03-20
  • 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
    It was identified that the shelf life of the product is labeled with the incorrect shelf-life of november 2020 rather than the correct shelf-life november 2018. the mislabeling extends the intended shelf-life of the product by two years. this label misidentification was discovered during ultradent's batch record review process. no doctor or patient complaints have been received to date.

Device

CONSEPSIS INDISPENSE SYRINGE

Manufacturer

CLINICAL RESEARCH DENTAL SUPPLIES AND SERVICES INC.