Genosyl DS recall
GENOSYL DS (Delivery System) console, for use as a vasodilator.
Why was Genosyl DS recalled?
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- GENOSYL DS (Delivery System) console, for use as a vasodilator.
- Recalling firm
- Vero Biotech, LLC
- Quantity
- 120 consoles (3 consoles affected)
- Distribution
- Distributed within US to Texas and Illinois.
- Recall date
- October 6, 2021
- Classification
- Class I
- Status
- Completed
- Agency
- FDA (device)