FDA-Device2021-01-06Class II
PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
Smiths Medical ASD Inc.
Hazard
A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.
Sold states
US nationwide distribution.
Affected count
238 devices
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0726-2021Don't want to check this manually?
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