Events

Recall of BIVONA INNER CANNULA FOR BIVONA ADULT 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
    96756
  • Event Risk Class
    II
  • Event Initiated Date
    2015-04-17
  • 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
    Smiths medical has become aware of the potential for compression of the inner cannula as a result of handling or certain cleaning methods used outside of the methods described in the ifu. compression can result in a shorter overall length and may lead to a build-up of secretions within the end of the tracheostomy tube with risk of infection or occlusion. smiths medical is therefore advising customers of additional information for safe and effective use of bivona inner cannula.

Device

BIVONA INNER CANNULA FOR BIVONA ADULT TRACHEOSTOMY TUBE
  • Model / Serial
    Model Catalog: BRCA85 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BRC275 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BRC270 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BRC280 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BRC285 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BRC290 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BRCA90 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BRCA80 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BRCA75 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BRCA70 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    BIVONA INNER CANNULA
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

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