Devices

Device Recall Bivona TTS Cuffed Neonatal Tracheostomy Tube

  • Modèle / numéro de série
    Lot numbers: 1644864, 1671968, 1713941, 1754786, 1835043, 1856208, 1875201, 1890748, 1913138, 1636740, 1655827, 1658988, 1667772, 1675682, 1687749, 1701032, 1704636, 1729117, 1745607, 1778507, 1809051, 1809052, 1821983, 1848186, 1851435, 1875202, 1896186, 1900039, 1914915, 1631504, 1633571, 1648150, 1651810, 1663885, 1680985, 1667773, 1679964, 1683713, 1683714, 1704637, 1713942, 1704638, 1749575, 1749576, 1778395, 1778396, 1782715, 1793502, 1804358, 1809053, 1821984, 1835044, 1856209, 1864910, 1883542, 1883543, 1887779, 1908912, 1914916, 1631505, 1631506, 1636040, 1644869, 1658989, 1680981, 1671972, 1679965, 1683715, 1692758, 1713943, 1704639, 1721313, 1725330, 1725329, 1745609, 1793503, 1804359, 1814087, 1821985, 1825903, 1821986, 1838655, 1851436, 1878007, 1891571, 1890749, 1904090, 1914917, and 1919156. Reorder numbers: 67N025, 67N030, 67N035, and 67N040.
  • 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 TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange).
  • 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 TTS Cuffed Neonatal Tracheostomy Tube
  • Modèle / numéro de série
    Lot numbers: 1648148, 1667782, 1675707, 1704654, 1721321, 1778519, 1796686, 1793516, 1774661, 1856219, 1868238, 1919159, 1644857, 1648155, 1655835, 1663879, 1679974, 1701034, 1696951, 1793517, 1796687, 1875211, 1919161, 1663892, 1671978, 1683687, 1793519, 1778473, 1809056, 1887784, 1896193, 1633576, 1642708, 1667809, 1651822, 1655831, 1663880, 1821993, and 1856220. Reorder number: 67SN025, 67SN030, 67SN035, and 67SN040.
  • 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 TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (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.