Events

Recall of Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD, 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
    32917
  • Event Risk Class
    Class 2
  • Event Number
    Z-0302-06
  • Event Initiated Date
    2005-02-17
  • Event Date Posted
    2005-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41075
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tube, Tracheostomy (W/Wo Connector) - Product Code BTO
  • Reason
    The word ped was printed on the neckflange instead of the word neo.
  • Action
    Consignees were notified via 'product advisory letter' dated 2/17/05 and requested to either notify all users or to return the product for replacement.

Device

Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
  • Model / Serial
    Lot 1338010.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Georgia, Illinois, Indiana, Maryland, Tennessee, Texas and Virginia.
  • Product Description
    Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Manufacturer Address
    Smiths Medical ASD, Inc., 5700 W 23rd Ave, Gary IN 46406-2617
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA