Some Bivona tracheostomy tubes may tear and become displaced during use resulting in a “catastrophic adverse event,” the company said in an urgent medical correction letter sent to customers.
‘Catastrophic’ Risk Linked To Smiths Medical Trach Tubes
Smiths Medical has recalled scores of Bivona tracheostomy tubes due to a manufacturing defect that can result in disastrous consequences. The company reports multiple injuries, and one death, linked to the devices.

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