Events

Recall of Bivona Tracheostomy Tube Tracheostomy Tubes

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
    80092
  • Event Risk Class
    Class 2
  • Event Number
    Z-2114-2018
  • Event Initiated Date
    2018-04-02
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164546
  • 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
    Carton labeling is printed with "sterile" indicated labeling, however the device is not sold as sterile.
  • Action
    Customers were notified via letter on approximately 04/02/2018. Instructions included to determine if there are any affected Customized Bivona¿ Tracheostomy Tubes in inventory, notify customers if the devices have been further distributed, arrange for the return of affected devices, and complete and return the acknowledgement response form.

Device

Bivona Tracheostomy Tube Tracheostomy Tubes
  • Model / Serial
    Part No. (Lot No.): CMZ3241N (DS009716), ST16EN80NSC194N (DS009794),  SU15AN70NSC153N (DS009577), FT17IN60NGC114N (DS009894), CMZ3331N (DS009761), XU17GS50NSF046N (DS009609), FT17IN60NGC114N (DS009861), AA16ES70NSC110N (DS009586), FT17IN70NSC111N (DS009856), FT16IN60NGC053N (DS009540), FU15AN55NSA076N (DS009464), AT17IS60NGC105N (DS009811)
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.
  • Product Description
    Bivona¿ Tracheostomy Tube Tracheostomy Tubes
  • Manufacturer
    Smiths Medical ASD Inc.

Manufacturer

Smiths Medical ASD Inc.
  • Manufacturer Address
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA