Device Recall Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube

Lot numbers: 1634475, 1646154, 1651839, 1672040, 1721272, 1729094, 1729106, 1749508, 1754749, 1770330, 1774597, 1778478, 1782866, 1782689, 1802344, 1809020, 1821941, 1825874, 1864872, 1875170, 1908871, 1914882, 1651837, 1667873, 1672039, 1675683, 1692771, 1679975, 1704685, 1708810, 1725218, 1729095, 1721273, 1737206, 1754750, 1774599, 1774598, 1802345, 1821942, 1829782, 1842384, 1856119, 1875171, 1887733, 1896161, 1904054, 1908872, 1646159, 1646155, 1672041, 1663914, 1667870, 1672036, 1679976, 1687696, 1692772, 1704687, 1704686, 1697000, 1721274, 1716554, 1729096, 1725219, 1725220, 1729107, 1741715, 1761966, 1749509, 1749510, 1757794, 1774600, 1770332, 1774601, 1774602, 1787319, 1802346, 1809021, 1821943, 1814053, 1829783, 1838634, 1851362, 1856120, 1870277, 1860806, 1883505, 1887734, 1887735, 1896162, 1914883, 1908873, 1651836, 1663919, 1667869, 1672038, 1679978, 1683722, 1704688, 1708811, 1725228, 1721275, 1733046, 1749511, 1757795, 1745563, 1757796, 1770333, 1774603, 1782869, 1782690, 1804334, 1809022, 1817444, 1825875, 1835015, 1842386, 1856121, 1860807, 1891548, 1908874, 1915870, and 1914884. With reorder numbers: 60NFP25, 60NFP30, 60NFP35, and 60NFP40.

Anesthesiology Devices

2

No

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

Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (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.