Z-2587-2021 Class I
FDA device recall Z-2587-2021 was initiated by Vero Biotech, LLC on September 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
- 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)