Events

Recall of Device Recall Smiths Bivona Adult Trach Tube

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
    36693
  • Event Risk Class
    Class 2
  • Event Number
    Z-0339-2007
  • Event Initiated Date
    2006-08-31
  • Event Date Posted
    2007-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49177
  • 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
    Tracheostomy tube - Product Code JOH
  • Reason
    Mislabeled- the outer diameter (od) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. the od is actually 11.8 mm.
  • Action
    Distributors and hospital consignees were notified via recall letter dated 8/25/06 to return all unused product to the firm. Distributors were asked to notify their customers of the recall.

Device

Device Recall Smiths Bivona Adult Trach Tube
  • Model / Serial
    Lots 1008187, 1023402 and 1012767.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution ---- including USA states of Arkansas, California, Georgia, Illinois, Kansas, Minnesota, Missouri, Ohio, Pennsylvania, Texas and countries of Canada and Netherlands.
  • Product Description
    Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.
  • 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