Events

Recall of TRACHEOSTOMY TUBES TTS WIRE REINFORCED SILICONE PEDIATRIC/NEONATAL

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
    25569
  • Event Risk Class
    I
  • Event Initiated Date
    2011-11-23
  • 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 a small number of complaints of customers experiencing difficulty disconnecting accessories from the connectors of the affected tubes. in some cases the customer was unable to disconnect the accessory or excessive force lead to decannulation of the tube and an emergency tracheostomy tube change was required. if the accessory is correctly connected to the affected tubes then there will be no issue with disconnection.

Device

TRACHEOSTOMY TUBES TTS WIRE REINFORCED SILICONE PEDIATRIC/NEONATAL
  • Model / Serial
    Model Catalog: 67P040 (Lot serial: 1631477 through 1923406); Model Catalog: 67N030 (Lot serial: 1631477 through 1923406); Model Catalog: 67N035 (Lot serial: 1631477 through 1923406); Model Catalog: 67P055 (Lot serial: 1631477 through 1923406); Model Catalog: 67P050 (Lot serial: 1631477 through 1923406); Model Catalog: 67P045 (Lot serial: 1631477 through 1923406); Model Catalog: 67N025 (Lot serial: 1631477 through 1923406); Model Catalog: 67P035 (Lot serial: 1631477 through 1923406); Model Catalog: 67P030 (Lot serial: 1631477 through 1923406); Model Catalog: 67N040 (Lot serial: 1631477 through 1923406); Model Catalog: 65P055 (Lot serial: 1631477 through 1923406); Model Catalog: 60PFP40 (Lot serial: 1631477 through 1923406); Model Catalog: 65P045 (Lot serial: 1631477 through 1923406); Model Catalog: 65P040 (Lot serial: 1631477 through 1923406); Model Catalog: 65P035 (Lot serial: 1631477 through 1923406); Model Catalog: 65P030 (Lot serial: 1631477 through 1923406); Model Catalog: 65P025 (Lot serial: 1631477 thr
  • Product Description
    Bivona Tracheostomy Tubes TTS - Pediatric/Neonatal
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

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