Device Recall Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube

  • Modelo / Serial
    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.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    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.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Smiths Medical ASD, Inc., 5700 W 23rd Ave, Gary IN 46406-2617
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA