GENOSYL DS (Delivery System) console, for use as a vasodilator.
This recall has been completed (originally issued September 9, 2021).
- Company
- Vero Biotech, Llc
- Recall Initiated
- September 9, 2021
- Recall Number
- Z-2587-2021
- Quantity
- 120 consoles (3 consoles affected)
- Firm Location
- Atlanta, GA
- Official Source
- View on FDA website ↗
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
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)
Root Cause
Process control
Action Taken
On 09/09/2021, Vero Biotech notified customers via certified mail with letter titled, "URGENT: MEDICAL DEVICE RECALL GENOSYL DS LIMITED MANUFACTURING DEFECT." The letter notified the customer of the issue and there were no actions to be taken as the three affected devices were removed from the field prior and replaced.