Vero Biotech, LLC: GENOSYL DS (Delivery System) console, for use as a vasodilator.

Is my product affected?

GENOSYL DS (Delivery System) console, for use as a vasodilator.

• UPC 00850000962026

Check against the official notice below — it lists the full affected range.

What happened

Vero Biotech, LLC is recalling GENOSYL DS (Delivery System) consoles used as vasodilators due to a manufacturing defect. The defect involves reversed inlet and outlet gas lines, which causes the device to deliver nitrogen dioxide (NO2) instead of the intended nitric oxide (NO). Three affected consoles with Model Number 601588-01 and specific serial numbers (G0294, G0378, and MA000065) were distributed to Texas and Illinois.

The recall record does not specify any remedy or instructions for affected consumers regarding what actions they should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).

Details from the source

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). Distribution: Distributed within US to Texas and Illinois. Quantity: 120 consoles (3 consoles affected) Lot/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)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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