FDA Medical Device Recalls (openFDA)
Vero Biotech, LLC: GENOSYL DS (Delivery System) console, for use as a vasodilator.
- Recall number
- Z-2587-2021
- Recalling firm
- Vero Biotech, LLC
- Product
- GENOSYL DS (Delivery System) console, for use as a vasodilator.
- Status
- Completed
- Initiated
- 2021-09-09
- Posted
- not on file
- Terminated
- not on file
- Reason
- Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
- Root cause
- Process control
- Action
- 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.
- Quantity
- 120 consoles (3 consoles affected)
- Distribution
- Distributed within US to Texas and Illinois.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MRN
- Firm FEI
- 3014617112
- Firm city
- Atlanta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28