Recalls / —
—#164546
Product
Bivona Tracheostomy Tube Tracheostomy Tubes
- FDA product code
- BTO — Tube, Tracheostomy (W/Wo Connector)
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- Affected 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)
Why it was recalled
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Root cause (FDA determination)
Error in labeling
Action the firm took
Customers were notified via letter on approximately 04/02/2018. Instructions included to determine if there are any affected Customized Bivona Tracheostomy Tubes in inventory, notify customers if the devices have been further distributed, arrange for the return of affected devices, and complete and return the acknowledgement response form.
Recalling firm
- Firm
- Smiths Medical ASD Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- Distribution pattern
- Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.
Timeline
- Recall initiated
- 2018-04-02
- Terminated
- 2018-11-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #164546. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.