FDAMay 29, 2024device
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
smiths medical asdsmithssmiths medical
UPCs
150213120056911502131200570715021312005714
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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