Z-2114-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 13, 2018
- Initiation Date
- April 2, 2018
- Termination Date
- November 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units
Product Description
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Reason for Recall
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Distribution Pattern
Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.
Code Information
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)