Device product
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Z-2485-2020
Product summary
- Event
- Event 85730
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 devices
- Official record key
device-enforcement:Z-2485-2020
Official wording
Reason: One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
Code information: Model Number: 60HA30, Lot: 3794165, SKU 60HA30
Distribution pattern: U.S: NE, TN, TX, and MS. Worldwide: France, Sweden, United Arab Emirates, UK, Netherlands, Czechia, Australia and Denmark.
Derived failure modes
-
Unknown
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.