Events

Recall of EXACTAMED ORAL DISPENSER 5ML

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

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
    30778
  • Event Risk Class
    II
  • Event Initiated Date
    2018-02-09
  • 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
    Baxter corporation is issuing a product recall for one lot of exactamed oral dispenser 5ml. the affected lot was packaged in individual pouches that are mislabeled with the incorrect product code (h93876101) and volume (1ml). the barrels are correctly marked with 5ml gradations and the outer carton in which the 5ml oral dispensers are packaged is correctly labeled.

Device

EXACTAMED ORAL DISPENSER 5ML
  • Model / Serial
    Model Catalog: H93876105 (Lot serial: 1203395)
  • Product Description
    EXACTAMED ORAL DISPENSER 5ML
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION