Recall Z-0564-2024 ยท MRN Apparatus, Nitric Oxide Delivery
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
| Date | Dec 15, 2023 (initiated Nov 17, 2023) |
| Status | Open, Classified |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.