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Smiths Medical ASD Inc. recalls Bivona Uncuffed Wire Endotracheal Tubes,
Recalled November 3, 2021 · FDA recall Z-0178-2022 · Smiths Medical ASD
Hazard
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm. · FDA Class II
Units
2191 devices
Sold at
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.
Description
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Product
Bivona Uncuffed Wire Endotracheal Tubes,
Manufacturer(s)
Smiths Medical ASD Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →