Devices

Device Recall Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube

  • Modèle / numéro de série
    Lot numbers: 1663911, 1667871, 1679947, 1679979, 1697001, 1716564, 1704689, 1725249, 1737207, 1745565, 1770334, 1774604, 1782699, 1787321, 1835016, 1838635, 1842387, 1856139, 1868258, 1864873, 1870278, 1891549, 1890724, 1896163, 1904055, 1908875, 1646527, 1646160, 1667872, 1672034, 1679980, 1704690, 1708812, 1725250, 1745566, 1729108, 1754755, 1774605, 1782700, 1774606, 1814054, 1817445, 1802347, 1825876, 1825876, 1829784, 1838636, 1851363, 1860808, 1864874, 1870279, 1877990, 1890725, 1890726, 1900016, 1904057, 1914885, 1646156, 1667865, 1659131, 1675684, 1679981, 1692773, 1687695, 1704691, 1721290, 1721289, 1741716, 1761972, 1774607, 1774608, 1778416, 1782826, 1796659, 1787322, 1817446, 1814055, 1821944, 1825877, 1835017, 1838637, 1851364, 1864875, 1877991, 1887736, 1868248, 1904058, 1913101, 1636068, 1675685, 1729056, 1737208, 1745567, 1766329, 1754756, 1770335, 1774609, 1787323, 1774610, 1821945, 1825878, 1851365, 1875172, 1887737, 1896164, 1900017, 1915871, 1913102, 1919142, and 1666270. Reorder number: 60PFP40, 60PFP45, 60PFP50, 60PFP55, and 60PFP60.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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
  • Description du dispositif
    Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0 (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
    Smiths Medical ASD, Inc.
  • 1 Event

Fabricant

Smiths Medical ASD, Inc.
  • Adresse du fabricant
    Smiths Medical ASD, Inc., 5700 W 23rd Ave, Gary IN 46406-2617
  • Société-mère du fabricant (2017)
    Smiths Group Plc
  • Source
    USFDA

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Device Recall Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube
  • Modèle / numéro de série
    Lot numbers: 1729045, 1692778, 1729046, 1692781, 1737214, 1657962, 1704702, 1737215, and 1683723. Reorder number: 60PFPS40, 60PFPS45, 60PFPS50, 60PFPS55, and 60PFPS60
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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
  • Description du dispositif
    Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0 (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
    Smiths Medical ASD, Inc.