Recall Z-2587-2021— Vero Biotech, LLC
Class I · Completed
Class I FDA medical device recall by Vero Biotech, LLC, initiated 2021-09-09. FDA's recall record names no specific 510(k) clearance for this event. Product: GENOSYL DS (Delivery System) console, for use as a vasodilator.. Reason: Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO)..
- Recalling firm
- Vero Biotech, LLC
- Classification
- Class I
- Status
- Completed
- Initiated
- 2021-09-09
- Firm location
- Atlanta, GA, United States
Product description
GENOSYL DS (Delivery System) console, for use as a vasodilator.
Reason for recall
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
Data sourced from openFDA. This site is unofficial and independent of the FDA.