Events

Recall of Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.

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
    31856
  • Event Risk Class
    Class 2
  • Event Number
    Z-0930-05
  • Event Initiated Date
    2005-04-26
  • Event Date Posted
    2005-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38630
  • 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 And Tube Cuff - Product Code JOH
  • Reason
    The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.
  • Action
    Consignees were notified via letter dated 4/26/05.

Device

Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; ...
  • Model / Serial
    Lot G651610.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Connecticut, Georgia, Illinois, Indiana, Minnesota, Missouri, New Mexico, and North Carolina.
  • Product Description
    Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
  • 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