Device Recall Bivona AireCuf Pediatric Tracheostomy Tube

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 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 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
  • 1 Event

제조사

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

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

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 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 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