Device Recall Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube

Lot numbers: 1710108, 1900021, 1687700, 1793461, 1814062, 1825882, 1891554, 1914891, 1687701, 1761973, 1778440, 1774624, 1900022, 1919143, 1635562, 1774625, 1851372 and 1868253. Reorder number: 60NFPS25, 60NFPS30, 60NFPS35, and 60NFPS40.

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 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.