Device Recall Bivona Uncuffed Pediatric Tracheostomy Tube

  • Model / Serial
    Lot numbers: 1636037, 1644866, 1663883, 1679951, 1692748, 1687733, 1704585, 1721276, 1729090, 1749525, 1782855, 1782691, 1774633, 1796667, 1821965, 1848203, 1864900, 1904079, 1919154, 1631500, 1633564, 1644868, 1651808, 1663893, 1642705, 1679952, 1671993, 1683695, 1687734, 1687735, 1721277, 1713919, 1704627, 1725230, 1725229, 1749526, 1745586, 1754752, 1749527, 1774634, 1778472, 1787320, 1793490, 1804335, 1821966, 1829813, 1825890, 1835036, 1848194, 1856122, 1864901, 1883534, 1890739, 1900032, 1908905, 1915878, 1631498, 1639397, 1639396, 1644865, 1644860, 1662327, 1680980, 1651812, 1655834, 1667789, 1671992, 1679954, 1679953, 1701533, 1683697, 1683698, 1687738, 1687739, 1687737, 1692746, 1701028, 1704589, 1704590, 1721278, 1713923, 1721280, 1713920, 1713921, 1704628, 1741730, 1749528, 1745587, 1741732, 1749532, 1749534, 1782848, 1782692, 1793491, 1796668, 1804336, 1821967, 1814077, 1809043, 1817468, 1821968, 1825891, 1829815, 1829814, 1835037, 1838649, 1842426, 1848195, 1851433, 1851427, 1856123, 1860827, 1875189, 1864902, 1875190, 1878002, 1883535, 1887767, 1887765, 1891560, 1896182, 1900033, 1904081, 1904080, 1908906, 1913119, 1914906, 1639399, 1645947, 1639398, 1639403, 1639400, 1639401, 1651807, 1658992, 1663894, 1663887, 1671987, 1672795, 1675700, 1672796, 1671988, 1672797, 1675701, 1671989, 1679955, 1679956, 1683702, 1687740, 1696909, 1704630, 1701029, 1704601, 1713924, 1716557, 1716558, 1704599, 1721282, 1716556, 1713926, 1725236, 1721281, 1749535, 1749536, 1741734, 1745590, 1749538, 1745596, 1749542, 1774636, 1778401, 1774635, 1778402, 1778403, 1770346, 1774637, 1774638, 1778405, 1778404, 1782693, 1782831, 1782695, 1782694, 1782832, 1796671, 1804338, 1814080, 1814078, 1814079, 1817469, 1817470, 1821969, 1796669, 1825893, 1796670, 1829816, 1825892, 1829817, 1838651, 1835038, 1842428, 1842427, 1838650, 1848197, 1848196, 1851431, 1851432, 1856132, 1864905, 1864904, 1856133, 1864903, 1870283, 1860828, 1875191, 1878003, 1878004, 1887768, 1887770, 1887769, 1887771, 1900034, 1891562, 1891561, 1900035, 1904082, 1908907, 1908908, 1913124, 1914908, 1914907, 1913123, 1634471, 1644856, 1644863, 1648165, 1658987, 1655836, 1663891, 1671985, 1679957, 1671984, 1679958, 1683703, 1687741, 1683667, 1687742, 1692743, 1692744, 1701030, 1704609, 1713928, 1713930, 1721286, 1716559, 1713929, 1704610, 1721284, 1749547, 1745594, 1745595, 1749546, 1749549, 1778392, 1741735, 1778391, 1770347, 1778393, 1774639, 1778394, 1782697, 1782820, 1793492, 1796672, 1814081, 1814082, 1809046, 1809045, 1821970, 1817471, 1825894, 1821971, 1829818, 1829819, 1825895, 1835039, 1842429, 1842430, 1848198, 1848188, 1848199, 1851430, 1856134, 1860829, 1860831, 1860830, 1864906, 1875192, 1878005, 1883536, 1883537, 1890745, 1891564, 1891563, 1896183, 1900036, 1904083, 1908909, 1913126, 1913125, 1914911, 1914910, 1631499, 1633566, 1642707, 1642709, 1648158, 1651819, 1655837, 1658982, 1658727, 1680979, 1667788, 1671983, 1679959, 1683706, 1679960, 1683705, 1687744, 1704612, 1704613, 1713931, 1725243, 1716562, 1713932, 1749555, 1749551, 1745592, 1741737, 1749553, 1770348, 1761978, 1749557, 1778421, 1757815, 1782839, 1782698, 1774640, 1778422, 1809047, 1821973, 1825896, 1804339, 1821972, 1796673, 1829820, 1825897, 1821974, 1835040, 1838652, 1842431, 1848189, 1851429, 1860832, 1860833, 1864907, 1870284, 1870285, 1875193, 1878006, 1890746, 1891565, 1891567, 1896184, 1904084, 1908910, 1913127, 1636038, 1642714, 1648154, 1658981, 1663888, 1663895, 1671980, 1679961, 1687745, 1683708, 1704616, 1721288, 1713933, 1704617, 1716563, 1725248, 1761596, 1741739, 1749559, 1749561, 1757818, 1774643, 1782846, 1778426, 1793493, 1796674, 1804340, 1814083, 1829821, 1821976, 1829822, 1821975, 1842432, 1848190, 1856135, 1848191, 1848192, 1856136, 1868252, 1875195, 1875194, 1883538, 1883539, 1891568, 1891569, 1900037, 1904086, 1904085, and 1913128. Reorder numbers: 60P025, 60P030, 60P035, 60P040, 60P045, 60P050, and 60P055.
  • Product Classification
  • 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 Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Smiths Medical ASD, Inc., 5700 W 23rd Ave, Gary IN 46406-2617
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot numbers: 1692735, 1729051, 1754765, 1770349, 1774642, 1793494, 1848193, 1692736, 1711384, 1729052, 1733036, 1754766, 1766332, 1774644, 1793495, 1835041, 1875197, 1875196, 1890747, 1914913, 1692737, 1721293, 1716571, 1729064, 1737247, 1741741, 1754768, 1759339, 1770350, 1778508, 1825899, 1835042, 1900038, 1638846, 1680978, 1696906, 1721292, 1713934, 1729086, 1757820, 1757821, 1782709, 1782849, 1848183, 1848182, 1913131, 1692739, 1701031, 1708814, 1716572, 1704618, 1713935, 1729065, 1754769, 1745599, 1782710, 1825900, 1851428, 1887772, 1904087, 1692740, 1704619, 1708815, 1729068, 1733034, 1754770, 1766334, 1770351, 1887773, 1692755, 1704620, 1729072, 1754771, 1754772, 1770352, and 1787327. Reorder numbers: 60SP025, 60SP030, 60SP035, 60SP040, 60SP045, 60SP050, and 60SP055.
  • Product Classification
  • 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 Uncuffed 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.
  • Manufacturer