Recall archive / FDA device enforcement
VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitri... — FDA record Z-0564-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 17, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- Cassette did not meet an 1n-process flow criterion.
- Classification
- Class II
- Recalling firm
- Vero Biotech, LLC
- Quantity
- 2 cassettes
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0564-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Code: W-0001-2023, Cassette serial numbers: GA01T707, GA01T108 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: AZ and FL
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 27, 2023
- Recall initiation date
- Nov 17, 2023
- Center classification date
- Dec 15, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.