Device product
VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use
Z-0564-2024
Product summary
- Event
- Event 93475
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 cassettes
- Official record key
device-enforcement:Z-0564-2024
Official wording
Reason: Cassette did not meet an 1n-process flow criterion.
Code information: Lot Code: W-0001-2023, Cassette serial numbers: GA01T707, GA01T108
Distribution pattern: US: AZ and FL
Derived failure modes
-
Unknown
Cassette did not meet an 1n-process flow criterion.