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U.S. Department of Health and Human Services

Class 1 Device Recall Bivona TTS Cuffed Pediatric Tracheostomy Tube

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  Class 1 Device Recall Bivona TTS Cuffed Pediatric Tracheostomy Tube see related information
Date Initiated by Firm November 28, 2011
Date Posted January 19, 2012
Recall Status1 Terminated 3 on October 17, 2014
Recall Number Z-0667-2012
Recall Event ID 60449
510(K)Number K912469  
Product Classification Tube, tracheostomy (w/wo connector) - Product Code BTO
Product Bivona TTS Cuffed Pediatric Tracheostomy Tube
Sizes 2.5 - 5.5 (With a Straight Neck Flange)

Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse.

Code Information Lot numbers: 1692762, 1754787, 1793510, 1817480, 1883552, 1679945, 1692763, 1692764, 1796683, 1793511, 1814096, 1835048, 1848177, 1887782, 1887781, 1631521, 1648147, 1655832, 1671969, 1663886, 1737254, 1725345, 1774655, 1787342, 1825908, 1883553, 1914924, 1692765, 1704648, 1713955, 1729057, 1749590, 1754789, 1804373, 1821991, 1851439, 1856221, 1878010, 1896190, 1913143, 1631522, 1648152, 1683683, 1713956, 1729101, 1848175, 1848176, 1868263, 1875208, 1883555, 1908926, 1919157, 1663878, 1671970, 1687752, 1692766, 1696953, 1708840, 1774656, 1787343, 1793512, 1821992, 1875209, 1868264, 1923407, 1666284, 1683684, 1701033, 1713957, 1749591, 1864913, 1856222, 1883554, 1887783, 1896191, and 1900043.  Reorder numbers: 67SP025, 67SP030, 67SP035, 67SP040, 67SP045, 67SP050, and 67SP055.   
Recalling Firm/
Smiths Medical ASD, Inc.
5700 W 23rd Ave
Gary IN 46406-2617
For Additional Information Contact Cindy Engelhardt, B.S. Ind. Chem., RAC
603-352-3812 Ext. 2923
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
Device Design
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.
Quantity in Commerce US distribution 153,033 devices ; Foreign 21,490 devices
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BTO and Original Applicant = BIVONA MEDICAL TECHNOLOGIES