FDA recall Z-0177-2022

Product

Bivona Aire-Cuf Endotracheal Tube

Reason for recall

Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2021-08-09

Report date

2021-11-03

Termination date

2023-10-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0177-2022