Device product
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
Z-2946-2020
Product summary
- Event
- Event 86345
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-2946-2020
Official wording
Reason: Label has the incorrect size for the tracheotomy tube.
Code information: Lot# 3952216
Distribution pattern: US Distribution to state of: CT
Derived failure modes
-
Labeling or packaging
Label has the incorrect