Vero Biotech, LLC Recall 88558
Description: GENOSYL DS (Delivery System) console, for use as a vasodilator.
Vero Biotech, LLC Recall 88558 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2587-2021 |
| Event ID | 88558 |
| Event Description | GENOSYL DS (Delivery System) console, for use as a vasodilator. |
| Product Type | Devices |
| Distribution | Distributed within US to Texas and Illinois. |
| Quantity | 120 consoles (3 consoles affected) |
| Recall Reason | Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO). |
| Device Classification | 20211006 |
| Device Code Info | Model Number: 601588-01, Serial Numbers G0294 (UDI (01)00850000962026(11)200728(21)G0294); G0378 (UDI (01)00850000962026(11)200917(21)G0378); and MA000065 (UDI (01)00850000962026(11)210511(21)MA000065) |
| Center Classification Date | 20210930 |
| Recall Initiation Date | 20210909 |
| Recalling Firm | Vero Biotech, LLC |
| Initial Notification | Letter |
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