Z-2114-2018 Class II Terminated
FDA device recall Z-2114-2018 was initiated by Smiths Medical ASD Inc. on Apr 2, 2018 and is designated Class II. Reason for recall: Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile. The recall status is terminated (terminated Nov 14, 2018). Affected quantity: 16 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 13, 2018
- Initiation Date
- Apr 2, 2018
- Termination Date
- Nov 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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2114-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026