FDA-Device2024-09-04Class I
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
Smiths Medical ASD Inc.
Hazard
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Sold states
Worldwide distribution.
Affected count
3138 units
Manufactured in
6000 Nathan Ln N, Minneapolis, MN, United States
Products
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2590-2024Don't want to check this manually?
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