FDA-Device2021-11-03Class II
Bivona Aire-Cuf Endotracheal Tube
Smiths Medical ASD Inc.
Hazard
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, KY, MA, MN, MO, NE, NJ, NY, OH, PA, SD, TN, TX, VA, WA and Hawaii. The countries of Bermuda, Canada, Germany, Denmark, Great Britain and Italy.
Affected count
7136 devices
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
Bivona Aire-Cuf Endotracheal Tube
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0177-2022Don't want to check this manually?
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