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Bivona® neonatal pediatric and adult tracheostomy products
Official notice
3 Jun 2024
Last checked
3 Jun 2024
An official Health Canada notice concerns Bivona® neonatal pediatric and adult tracheostomy products. 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 Published 2024-06-03.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75610
Official notice
2024-06-03
The hazard
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. Recall start date: May 24, 2024
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Product 2
Product 3
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Smiths Medical Asd, Bivona® Neonatal Pediatric And Adult Tracheostomy.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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