Z-0564-2024Class II

VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and...

Name: Z-0564-2024 VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and...
Creator: Vero Biotech, LLC
Published: 2023-11-17
License: https://open.fda.gov/license/

Vero Biotech Inc. / initiated 2023-11-17 / Open, Classified / root cause: manufacturing process

FDA source

Vero Biotech, LLC began a recall of VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point... on 2023-11-17. FDA classified it as Class II and gives the reason as "Cassette did not meet an 1n-process flow criterion". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0564-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-17
Posted: 2023-12-15
Recalling firm: Vero Biotech Inc.
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
Product code: MRN Apparatus, Nitric Oxide Delivery
Reason for recall: Cassette did not meet an 1n-process flow criterion.
Root cause tag: manufacturing process
FDA 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 in commerce: 2 cassettes
Distribution: US: AZ and FL
Product codes and lots: Lot Code: W-0001-2023, Cassette serial numbers: GA01T707, GA01T108

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0564-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0564-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-15

Product code MRN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)