FDA Medical Device Recalls (openFDA)
Vero Biotech, LLC: VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use
- Recall number
- Z-0564-2024
- Recalling firm
- Vero Biotech, LLC
- Product
- VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use
- Status
- Open, Classified
- Initiated
- 2023-11-17
- Posted
- 2023-12-15
- Terminated
- not on file
- Reason
- Cassette did not meet an 1n-process flow criterion.
- Root cause
- Process control
- Action
- VERO BIOTECH issued an URGENT: MEDICAL DEVICE REMOVAL notice to its consignees on 11/17/2023 via email, The notice explained the issue and advised the consignee of the removal of the device from their possession on 11/03/2023.
- Quantity
- 2 cassettes
- Distribution
- US: AZ and FL
- Lot, serial or model codes
- Lot Code: W-0001-2023, Cassette serial numbers: GA01T707, GA01T108
- 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