medical Class I Updated 2021-10-06

Vero Biotech, LLC recalls GENOSYL DS (Delivery System) console, for use as a vasodilat

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Distributed within US to Texas and Illinois.
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)
View official government recall

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