Devices

Device Recall Bivona TTS Cuffed Pediatric Tracheostomy Tube

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 1692762, 1754787, 1793510, 1817480, 1883552, 1679945, 1692763, 1692764, 1796683, 1793511, 1814096, 1835048, 1848177, 1887782, 1887781, 1631521, 1648147, 1655832, 1671969, 1663886, 1737254, 1725345, 1774655, 1787342, 1825908, 1883553, 1914924, 1692765, 1704648, 1713955, 1729057, 1749590, 1754789, 1804373, 1821991, 1851439, 1856221, 1878010, 1896190, 1913143, 1631522, 1648152, 1683683, 1713956, 1729101, 1848175, 1848176, 1868263, 1875208, 1883555, 1908926, 1919157, 1663878, 1671970, 1687752, 1692766, 1696953, 1708840, 1774656, 1787343, 1793512, 1821992, 1875209, 1868264, 1923407, 1666284, 1683684, 1701033, 1713957, 1749591, 1864913, 1856222, 1883554, 1887783, 1896191, and 1900043.  Reorder numbers: 67SP025, 67SP030, 67SP035, 67SP040, 67SP045, 67SP050, and 67SP055.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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
  • 제품 설명
    Bivona TTS Cuffed 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
    Smiths Medical ASD, Inc.
  • 1 Event

제조사

Smiths Medical ASD, Inc.
  • 제조사 주소
    Smiths Medical ASD, Inc., 5700 W 23rd Ave, Gary IN 46406-2617
  • 제조사 모회사 (2017)
    Smiths Group Plc
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall Bivona TTS Cuffed Pediatric Tracheostomy Tube
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 1667791, 1683669, 1761983, 1793504, 1804360, 1814089, 1814088, 1851437, 1883545, 1883544, 1631507, 1644862, 1655828, 1667774, 1675703, 1683717, 1713944, 1729123, 1725331, 1745610, 1774648, 1804361, 1821987, 1825904, 1842438, 1856210, 1875203, 1887780, 1908913, 1914918, 1633455, 1631511, 1633572, 1642719, 1648160, 1658239, 1658724, 1680983, 1683954, 1667775, 1671982, 1675705, 1679966, 1683718, 1683670, 1683671, 1692759, 1704640, 1713945, 1704641, 1713946, 1721314, 1749578, 1741748, 1749579, 1774649, 1782716, 1782859, 1804362, 1814090, 1817476, 1817477, 1829826, 1842440, 1848187, 1856211, 1875204, 1883546, 1900040, 1908915, 1914919, 1631793, 1631512, 1634474, 1640975, 1648153, 1651815, 1652387, 1658994, 1658984, 1667776, 1667778, 1681511, 1680984, 1672791, 1672793, 1671986, 1672792, 1676338, 1679968, 1679967, 1683672, 1683673, 1683719, 1704642, 1713947, 1721315, 1721317, 1721316, 1713948, 1725333, 1733060, 1725334, 1733059, 1737251, 1749580, 1745611, 1745612, 1757824, 1749581, 1778464, 1774650, 1782717, 1778465, 1796679, 1793505, 1804363, 1817478, 1814091, 1814092, 1825905, 1829827, 1829828, 1838656, 1848181, 1835045, 1848180, 1856212, 1860834, 1875205, 1870286, 1878008, 1883547, 1891573, 1891572, 1896187, 1908917, 1908916, 1913139, 1915882, 1914920, 1631516, 1631515, 1644872, 1636041, 1640976, 1655829, 1655830, 1651814, 1648162, 1658985, 1667779, 1658995, 1679969, 1671990, 1683674, 1683720, 1683675, 1683676, 1696949, 1716579, 1692760, 1716578, 1713950, 1713949, 1704643, 1737252, 1741750, 1741749, 1749582, 1745614, 1749583, 1757825, 1774651, 1778406, 1774652, 1778407, 1782834, 1782718, 1782719, 1782835, 1796680, 1809054, 1804364, 1817479, 1814093, 1821988, 1829829, 1825906, 1835046, 1838657, 1848179, 1860835, 1856214, 1856213, 1870289, 1870287, 1868241, 1878009, 1883548, 1896188, 1908921, 1908920, 1908918, 1915883, 1914921, 1633573, 1638658, 1644858, 1648157, 1658990, 1651813, 1667780, 1676339, 1671991, 1675706, 1683677, 1679970, 1683678, 1683679, 1687750, 1704644, 1692761, 1713951, 1704645, 1708838, 1716580, 1713952, 1721319, 1741751, 1737253, 1749584, 1745615, 1749585, 1770354, 1749586, 1757826, 1774653, 1778408, 1782720, 1778409, 1793506, 1804367, 1793507, 1804365, 1796681, 1809055, 1804366, 1825907, 1829830, 1842441, 1856216, 1856215, 1864911, 1875206, 1883549, 1890750, 1891574, 1896189, 1900041, 1908922, 1913140, 1914922, 1633574, 1638659, 1651809, 1639463, 1667781, 1658991, 1644870, 1663889, 1652388, 1671994, 1683681, 1679972, 1679971, 1683682, 1683680, 1687751, 1696950, 1704646, 1704647, 1708839, 1716581, 1713953, 1713954, 1749587, 1741752, 1745616, 1749589, 1745617, 1749588, 1774654, 1778412, 1778411, 1778414, 1778413, 1793508, 1796682, 1804372, 1804371, 1793509, 1814094, 1814095, 1821989, 1829831, 1842442, 1848178, 1821990, 1856217, 1835047, 1856218, 1851438, 1864912, 1860836, 1875207, 1883550, 1883551, 1891576, 1891575, 1897531, 1900042, 1908923, 1908924, and 1913141. Reorder number: 67P025, 67P030, 67P035, 67P040, 67P045, 67P050, and 67P055.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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
  • 제품 설명
    Bivona TTS Cuffed 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
    Smiths Medical ASD, Inc.