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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Code: W-0001-2023, Cassette serial numbers: GA01T707, GA01T108
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Vero Biotech, LLC
- Reason for Recall:
- Cassette did not meet an 1n-process flow criterion.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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
Product Codes/Lot Numbers:
Lot Code: W-0001-2023, Cassette serial numbers: GA01T707, GA01T108
Distribution:
Distributed in: US, AZ, FL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0564-2024
Related Recalls
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.