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

Z-2587-2021 Class I

Recalled by Vero Biotech, LLC — Atlanta, GA

FDA device recall Z-2587-2021 was initiated by Vero Biotech, LLC on Sep 9, 2021 and is designated Class I. 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). Affected quantity: 120 consoles (3 consoles affected).

Recall Details

Product Type: Devices
Report Date: Oct 6, 2021
Initiation Date: Sep 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)

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2587-2021
openFDA file date: Oct 6, 2026
Loaded by RegDataLab: Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.