Devices

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

  • Model / Serial
    Lot numbers: 1729045, 1692778, 1729046, 1692781, 1737214, 1657962, 1704702, 1737215, and 1683723. Reorder number: 60PFPS40, 60PFPS45, 60PFPS50, 60PFPS55, and 60PFPS60
  • Product Classification
    Anesthesiology Devices
  • 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 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.
  • 1 Event

Manufacturer

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

One device with a similar name

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Device Recall Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube
  • Model / Serial
    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.
  • Product Classification
    Anesthesiology Devices
  • 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 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.