Device Recall Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube

Lot numbers: 1663911, 1667871, 1679947, 1679979, 1697001, 1716564, 1704689, 1725249, 1737207, 1745565, 1770334, 1774604, 1782699, 1787321, 1835016, 1838635, 1842387, 1856139, 1868258, 1864873, 1870278, 1891549, 1890724, 1896163, 1904055, 1908875, 1646527, 1646160, 1667872, 1672034, 1679980, 1704690, 1708812, 1725250, 1745566, 1729108, 1754755, 1774605, 1782700, 1774606, 1814054, 1817445, 1802347, 1825876, 1825876, 1829784, 1838636, 1851363, 1860808, 1864874, 1870279, 1877990, 1890725, 1890726, 1900016, 1904057, 1914885, 1646156, 1667865, 1659131, 1675684, 1679981, 1692773, 1687695, 1704691, 1721290, 1721289, 1741716, 1761972, 1774607, 1774608, 1778416, 1782826, 1796659, 1787322, 1817446, 1814055, 1821944, 1825877, 1835017, 1838637, 1851364, 1864875, 1877991, 1887736, 1868248, 1904058, 1913101, 1636068, 1675685, 1729056, 1737208, 1745567, 1766329, 1754756, 1770335, 1774609, 1787323, 1774610, 1821945, 1825878, 1851365, 1875172, 1887737, 1896164, 1900017, 1915871, 1913102, 1919142, and 1666270. Reorder number: 60PFP40, 60PFP45, 60PFP50, 60PFP55, and 60PFP60.

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 Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0 (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.