medical Class II Updated 2018-06-13

Smiths Medical ASD Inc. recalls Bivona¿ Tracheostomy Tube Tracheostomy Tubes

Recalled Product

Bivona¿ Tracheostomy Tube Tracheostomy Tubes

Hazard / Issue

Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.

Issued by

FDA

Affected States: CA, FL, GA, ID, NJ, NM, OH, VA
Lot/Code Info: Part No. (Lot No.): CMZ3241N (DS009716), ST16EN80NSC194N (DS009794), SU15AN70NSC153N (DS009577), FT17IN60NGC114N (DS009894), CMZ3331N (DS009761), XU17GS50NSF046N (DS009609), FT17IN60NGC114N (DS009861), AA16ES70NSC110N (DS009586), FT17IN70NSC111N (DS009856), FT16IN60NGC053N (DS009540), FU15AN55NSA076N (DS009464), AT17IS60NGC105N (DS009811)
View official government recall

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