Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended Recalled by Smiths Medical ASD Inc. Due to Label has the incorrect size for the tracheotomy...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Smiths Medical ASD Inc. directly.
Affected Products
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
Quantity: 3 units
Why Was This Recalled?
Label has the incorrect size for the tracheotomy tube.
Where Was This Sold?
This product was distributed to 1 state: CT
About Smiths Medical ASD Inc.
Smiths Medical ASD Inc. has 169 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report