FDA-Device2020-07-08Class II
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Smiths Medical ASD Inc.
Hazard
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
Sold states
U.S: NE, TN, TX, and MS. Worldwide: France, Sweden, United Arab Emirates, UK, Netherlands, Czechia, Australia and Denmark.
Affected count
20 devices
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2485-2020Don't want to check this manually?
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