Device product

Bivona¿ Tracheostomy Tube Tracheostomy Tubes

Z-2114-2018

April 02, 2018

Class II

Product summary

Firm: Smiths Medical ASD Inc.
Event: Event 80092
Status: Terminated
Classification: Class II
Quantity: 16 units
Official record key: device-enforcement:Z-2114-2018

Official wording

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

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)

Distribution pattern: Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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