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Smiths Medical ASD Inc. recalls Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Recalled June 13, 2018 · FDA recall Z-2114-2018 · Smiths Medical ASD
Hazard
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile. · FDA Class II
Units
16 units
Sold at
Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.
Description
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Product
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Manufacturer(s)
Smiths Medical ASD Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →