FDA-Device2020-09-16Class II
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
Smiths Medical ASD Inc.
Hazard
Label has the incorrect size for the tracheotomy tube.
Sold states
US Distribution to state of: CT
Affected count
3 units
Manufactured in
6000 Nathan Ln N, Minneapolis, MN, United States
Products
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2946-2020Don't want to check this manually?
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