Devices

Device Recall Bivona AireCuf Pediatric Tracheostomy Tube

  • Modèle / numéro de série
    Lot numbers: 1692751, 1787332, 1663890, 1887777, 1896185, 1919155, 1704633, 1749574, 1741746, 1793499, 1817475, 1821981, 1856173, 1883541, 1638919, 1704634, 1713940, 1729116, 1770353, 1787333, 1829825, 1864909, 1875200, 1639462, 1671975, 1793500, 1754775, 1787334, 1809050, 1814085, 1825902, 1821982, 1842436, 1842437, 1848185, 1856174, 1692757, 1704635, 1708821, 1741747, and 1887778. Reorder number: 65SP025, 65SP030, 65SP035, 65SP040, 65SP045, 65SP050, and 65SP055.
  • 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 Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 || 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 AireCuf Pediatric Tracheostomy Tube
  • Modèle / numéro de série
    Lot numbers: 1774646, 1804348, 1829824, 1842434, 1856172, 1644861, 1651806, 1667770, 1696947, 1713939, 1749571, 1749572, 1754774, 1793497, 1804349, 1821979, 1842435, 1875199, 1887775, 1636039, 1651820, 1648166, 1655826, 1671973, 1683712, 1687748, 1692752, 1696948, 1704632, 1749573, 1774647, 1796678, 1793498, 1821980, 1838654, 1887776, and 1904089. Reorder number: 65P045, 65P050, and 65P055.
  • 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 Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 || 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.