Reported Oct 6, 2021 · Completed
GENOSYL DS (Delivery System) console, for use as a vasodilator.
Vero Biotech, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vero Biotech, LLC · 387 Technology Cir Nw Ste 125 · Atlanta, GA · 30313-2411
Is this the product you have?
- GENOSYL DS (Delivery System) console, for use as a vasodilator.
- Lot codes and dates
- Model Number601588-01, 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)
- Amount recalled
- 120 consoles (3 consoles affected)
Where it was sold
Why it was recalled
Stop using this product now
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Vero Biotech, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.