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Smiths Medical ASD Inc. recalls Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheo
Recalled September 16, 2020 · FDA recall Z-2946-2020 · Smiths Medical ASD
Hazard
Label has the incorrect size for the tracheotomy tube. · FDA Class II
Units
3 units
Sold at
US Distribution to state of: CT
Description
Label has the incorrect size for the tracheotomy tube.
Product
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.
Manufacturer(s)
Smiths Medical ASD Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →