Events

Recall of BUILD IT FR MINI MIX - AUTO MIX SYRINGE REFILLS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PENTRON CLINICAL TECHNOLOGIES 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
    76150
  • Event Risk Class
    III
  • Event Initiated Date
    2010-11-02
  • 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
    Mini mix kits were inadvertently labeled with the term "assorted kit" rather than the correct shade designation a2. however although the sytringes themselves are missing the a2 shade designation the outer package for the kits correctly indicates the correct shade of the product inside.

Device

BUILD IT FR MINI MIX - AUTO MIX SYRINGE REFILLS
  • Model / Serial
    Model Catalog: N32FA (Lot serial: 3519993); Model Catalog: N32FA (Lot serial: 3536336)
  • Product Description
    Build-It FR Mini Mix
  • Manufacturer
    PENTRON CLINICAL TECHNOLOGIES LLC

Manufacturer

PENTRON CLINICAL TECHNOLOGIES LLC