Events

Recall of TRACHEOSTOMY TUBES TIGHT TO SHAFT (TTS) AIRE-CUF SILICONE ADULT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITHS MEDICAL CANADA LTD. (SIMS).

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
    27193
  • Event Risk Class
    III
  • Event Initiated Date
    2006-08-31
  • 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 outer diameter (od) documented on the tray inner and outer box labels did not match the od printed on the tube flange. the od stated on the labelling is 11.0mm and the od of the tube is actually 11.8mm.

Device

TRACHEOSTOMY TUBES TIGHT TO SHAFT (TTS) AIRE-CUF SILICONE ADULT
  • Model / Serial
    Model Catalog: 670185 (Lot serial: 1008187)
  • Product Description
    8.5mm BIVONA ADULT TTS TRACHESTOMY TUBE
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    HC