Recall Z-0564-2024— Vero Biotech, LLC
Class II · Ongoing
Class II FDA medical device recall by Vero Biotech, LLC, initiated 2023-11-17. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Cassette did not meet an 1n-process flow criterion..
- Recalling firm
- Vero Biotech, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-17
- Firm location
- Atlanta, GA, United States
Product description
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
Reason for recall
Cassette did not meet an 1n-process flow criterion.
Data sourced from openFDA. This site is unofficial and independent of the FDA.