Recall of INNER CANNULA FOR BLUE LINE TRACHEOSTOMY TUBE

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
    82196
  • Event Risk Class
    II
  • Event Country
  • 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
    Package seals of product may have opened and may compromise sterility.

Device

  • Model / Serial
    Model Catalog: 566090 (Lot serial: DEV LIC # 4330 25532); Model Catalog: 566070 (Lot serial: DEV LIC # 4330 25532); Model Catalog: 566070 (Lot serial: 108760 110736 111579); Model Catalog: 566090 (Lot serial: 108760 110736 111579)
  • Product Description
    INNER CANNULA FOR BLUE LINE TRACH. TUBE
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
  • Source
    HC