Product Wiki · Recalls · Health Canada — Medical Devices

Bivona® Neonatal/Pediatric and Adult Tracheostomy Products — recall 75610

Health Canada — Medical Devices · Canada · 2024-06-03 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
75610
Date of alert
2024-06-03
Country / jurisdiction
Canada
Authority classification
Type I
Notice type
recall
Product category
Anaesthesiology
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/bivonar-neonatalpediatric-and-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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