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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Vero Biotech, LLC: GENOSYL DS Generation 3 Cassettes Recalled for Flow Criterion Failure

Agency Publication Date: December 15, 2023
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Summary

Vero Biotech, LLC is recalling 2 units of the GENOSYL DS (Delivery System) Generation 3 Cassette, model number 602722-01. These cassettes are used to generate and deliver nitric oxide gas for inhalation therapy. The recall was initiated because the cassettes did not meet specific internal flow criteria during the manufacturing process, which could affect the delivery of the medication. Consumers should contact their healthcare provider or the manufacturer to address this issue.

Risk

The failure to meet flow criteria could result in the device delivering an incorrect amount of nitric oxide or failing to deliver the therapy as intended, which could lead to respiratory complications for the patient.

What You Should Do

  1. Locate your GENOSYL DS Generation 3 Cassette and check the model and identification markings.
  2. Verify if your device is affected by checking for Model Number 602722-01 and Lot Code W-0001-2023.
  3. Specifically check for Serial Numbers GA01T707 or GA01T108, which are the only two units affected by this recall.
  4. If you possess one of these specific serial numbers, contact your healthcare provider or Vero Biotech immediately for further instructions and to arrange for a replacement.
  5. For additional questions, contact Vero Biotech, LLC or the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette
Model / REF:
602722-01
Lot Numbers:
W-0001-2023
GA01T707 (Serial Number)
GA01T108 (Serial Number)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93475
Status: Active
Manufacturer: Vero Biotech, LLC
Sold By: Specialized medical distributors
Manufactured In: United States
Units Affected: 2 cassettes
Distributed To: Arizona, Florida

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.