Vero Biotech recalls GENOSYL DS consoles for vasodilator use due to manufacturing defect causing nitrogen dioxide instead of nitric oxide delivery. Affected units have specific model and serial numbers.
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
Vero Biotech recalls its GENOSYL DS console for vasodilator use because a manufacturing defect reverses gas lines, delivering dangerous nitrogen dioxide instead of the intended nitric oxide. This could cause serious health risks if used as intended.
The console has a manufacturing defect that reverses the inlet and outlet gas lines. This causes it to deliver nitrogen dioxide (NO2) instead of nitric oxide (NO), which is intended for vasodilator use. Nitrogen dioxide is a toxic gas that can cause serious health issues including respiratory distress.
Users of the GENOSYL DS console for vasodilator treatment are affected. Patients using this device for medical purposes are at highest risk due to the potential for harmful gas delivery.
Check for model number 601588-01 and serial numbers G0294, G0378, or MA000065. The console is sold for medical vasodilator use and has specific UDI codes associated with these serial numbers.
Immediately stop using the GENOSYL DS console if you have it. The defect causes dangerous gas delivery that could cause serious health risks.
The model number is 601588-01.
Affected serial numbers are G0294, G0378, and MA000065.
The recall record does not specify any remedy.
We’ve drafted a message you can send Vero Biotech to request your refund or repair — edit it as you like.
Subject: Recall Z-2587-2021 — Vero Biotech Vero Biotech Hello, I own a Vero Biotech that is covered by recall Z-2587-2021 from Vero Biotech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
