Home / Recalls / Vero Biotech, LLC / Z-2587-2021

Z-2587-2021 Class I

Recalled by Vero Biotech, LLC — Atlanta, GA

Recall Details

Product Type: Devices
Report Date: October 6, 2021
Initiation Date: September 9, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 120 consoles (3 consoles affected)

Product Description

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

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 Pattern

Distributed within US to Texas and Illinois.

Code Information

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)