—#105985

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.

FDA product code: BTO — Tube, Tracheostomy (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K912469
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 5700 W 23rd Ave, Gary, Indiana 46406-2617

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2011-11-28
Posted by FDA: 2012-01-19
Terminated: 2014-10-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105985. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.