Events

Recall of TRACHEOSTOMY TUBE HOLDER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DALE MEDICAL PRODUCTS 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
    54264
  • Event Risk Class
    II
  • Event Initiated Date
    2007-10-19
  • 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
    Dale models 240 & 242 blue tracheostomy tube holders are breaking as a result of customers altering the product by trimming the tab near the securing sitch and weakening product integrity.

Device

TRACHEOSTOMY TUBE HOLDER
  • Model / Serial
    Model Catalog: (Lot serial: Model 240 Blue & 242 Blue)
  • Product Description
    Dale Tracheostomy Tube Holder
  • Manufacturer
    DALE MEDICAL PRODUCTS INC.

Manufacturer

DALE MEDICAL PRODUCTS INC.