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Health Canada Medical devices

Bivona® Neonatal/Pediatric and Adult Tracheostomy Products

Issued June 3, 2024
Issue
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. Recall start date: May 24, 2024
Hazard description
Performance
Product
Product name
Bivona® Neonatal/Pediatric and Adult Tracheostomy Products
Reference
ID
RA-75610