Events

Recall of Device Recall Bivona TTS Cuffed Neonatal Tracheostomy 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
    60449
  • Event Risk Class
    Class 1
  • Event Number
    Z-0657-2012
  • Event Initiated Date
    2011-11-28
  • Event Date Posted
    2012-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105982
  • 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
    Difficulty disconnecting accessories from the bivona uncuffed neonatal, pediatric and flextend tracheostomy tubes tr3 connector, which may result in a delay in initiating therapy or patient discomfort. if excessive force is used to detach the accessory, this may result in decannulation of the tube which could result in serious injury or death; especially if no replacement tracheostomy tube is imm.
  • Action
    Smith Medical sent an Urgent Field Safety Notice dated November 28, 2011, via U.S. Mail to all affected consignees. The notice identified the product, description of problem, and actions to be taken. This notice included a Customer Information Bulletin and Urgent Field Safety Notice Confirmation Form. Customers were instructed to 1) identify all affected unused product in inventory and segregate it to a quarantine location; 2) complete and return the attached Confirmation Form by fax to 219-989-7259 or email to bivona.tr3@smiths-medical.com; and 3) distributors were instructed to stop distributing and provide Smith Medical with a list of their customers, including contact details, so that Smith Medical can notify the customers of this notice. For questions contact Smiths Medical Customer Service at 800-258-5361, Option 1.

Device

Device Recall Bivona TTS Cuffed Neonatal Tracheostomy Tube
  • Model / Serial
    Lot numbers: 1644864, 1671968, 1713941, 1754786, 1835043, 1856208, 1875201, 1890748, 1913138, 1636740, 1655827, 1658988, 1667772, 1675682, 1687749, 1701032, 1704636, 1729117, 1745607, 1778507, 1809051, 1809052, 1821983, 1848186, 1851435, 1875202, 1896186, 1900039, 1914915, 1631504, 1633571, 1648150, 1651810, 1663885, 1680985, 1667773, 1679964, 1683713, 1683714, 1704637, 1713942, 1704638, 1749575, 1749576, 1778395, 1778396, 1782715, 1793502, 1804358, 1809053, 1821984, 1835044, 1856209, 1864910, 1883542, 1883543, 1887779, 1908912, 1914916, 1631505, 1631506, 1636040, 1644869, 1658989, 1680981, 1671972, 1679965, 1683715, 1692758, 1713943, 1704639, 1721313, 1725330, 1725329, 1745609, 1793503, 1804359, 1814087, 1821985, 1825903, 1821986, 1838655, 1851436, 1878007, 1891571, 1890749, 1904090, 1914917, and 1919156. Reorder numbers: 67N025, 67N030, 67N035, and 67N040.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide: AZ, CA, CO, CT,DE, FL, GA, HI, IL, IN, KS, KY, LA, SC, TX, OR, NJ, MO, UT, MI, NY, NM, MA, MN, MS, NC, ND, NE, NH, NV, OH, OK, OR, RI, SD, TN, VA, VT, WA, WI, WV including Washinton DC, Australia, Austria, Barbados, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gibraltar, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, New Zeland, Norway, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United States, Vatican City State
  • Product Description
    Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange).
  • 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