Class 1 Device Recall Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube

• Date Initiated by Firm: November 28, 2011
• Date Posted: January 19, 2012
• Recall Status: Terminated on October 17, 2014
• Recall Number: Z-0660-2012
• Recall Event ID: 60449
• 510(K)Number: K912469
• Product Classification: Tube, tracheostomy (w/wo connector) - Product Code BTO
• Product: Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped 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: 1634475, 1646154, 1651839, 1672040, 1721272, 1729094, 1729106, 1749508, 1754749, 1770330, 1774597, 1778478, 1782866, 1782689, 1802344, 1809020, 1821941, 1825874, 1864872, 1875170, 1908871, 1914882, 1651837, 1667873, 1672039, 1675683, 1692771, 1679975, 1704685, 1708810, 1725218, 1729095, 1721273, 1737206, 1754750, 1774599, 1774598, 1802345, 1821942, 1829782, 1842384, 1856119, 1875171, 1887733, 1896161, 1904054, 1908872, 1646159, 1646155, 1672041, 1663914, 1667870, 1672036, 1679976, 1687696, 1692772, 1704687, 1704686, 1697000, 1721274, 1716554, 1729096, 1725219, 1725220, 1729107, 1741715, 1761966, 1749509, 1749510, 1757794, 1774600, 1770332, 1774601, 1774602, 1787319, 1802346, 1809021, 1821943, 1814053, 1829783, 1838634, 1851362, 1856120, 1870277, 1860806, 1883505, 1887734, 1887735, 1896162, 1914883, 1908873, 1651836, 1663919, 1667869, 1672038, 1679978, 1683722, 1704688, 1708811, 1725228, 1721275, 1733046, 1749511, 1757795, 1745563, 1757796, 1770333, 1774603, 1782869, 1782690, 1804334, 1809022, 1817444, 1825875, 1835015, 1842386, 1856121, 1860807, 1891548, 1908874, 1915870, and 1914884. With reorder numbers: 60NFP25, 60NFP30, 60NFP35, and 60NFP40.
• Recalling Firm/ Manufacturer: 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: 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