Recall Z-2587-2021 ยท MRN Apparatus, Nitric Oxide Delivery
Vero Biotech, LLC
GENOSYL DS (Delivery System) console, for use as a vasodilator.
| Date | Sep 9, 2021 |
| Status | Completed |
| Reason | Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO). |
| Root cause | Process control |
| Action | On 09/09/2021, Vero Biotech notified customers via certified mail with letter titled, "URGENT: MEDICAL DEVICE RECALL GENOSYL DS LIMITED MANUFACTURING DEFECT." The letter notified the customer of the issue and there were no actions to be taken as the three affected devices were removed from the field prior and replaced. |
| Quantity | 120 consoles (3 consoles affected) |
| Distribution | Distributed within US to Texas and Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.