Device Recall Bivona

3272963

Anesthesiology Devices

2

No

US: CA, ILM NC, GA, NE, MA, CO, CT, MO, TN, LA, MD, MN, FL, SC,M OK, MI, PA, TX, WA, WI.

Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.

Lots 1055779, 1245930, 1263830, 1302670, 1310500, 1324570, 1351420, 1351480, G654810, G689730 and G726388.

Ear, Nose, and Throat Devices

1

No

Worldwide, including USA, Canada, Netherlands and United Kingdom.

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.

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.

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 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.

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.

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 TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange).

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.

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 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.