Device Recall Bivona

  • Model / Serial
    Lot 1134710
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, England and France
  • Product Description
    Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Portex, Inc, 5700 West 23rd Ave, Gary IN 46406
  • Source
    USFDA

18 devices with a similar name

Learn more about the data here

  • Model / Serial
    3272963
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: CA, ILM NC, GA, NE, MA, CO, CT, MO, TN, LA, MD, MN, FL, SC,M OK, MI, PA, TX, WA, WI.
  • Product Description
    Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
  • Manufacturer
  • Model / Serial
    Lots 1055779, 1245930, 1263830, 1302670, 1310500, 1324570, 1351420, 1351480, G654810, G689730 and G726388.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Netherlands and United Kingdom.
  • Product Description
    Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • 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 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
  • Model / Serial
    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.
  • Product Classification
  • 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 TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange).
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • 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 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
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