Vero Biotech GENOSYL DS cassette recalled for manufacturing flow defect
Vero Biotech is recalling GENOSYL DS Generation 3 cassettes that failed to meet manufacturing flow specifications. The recall affects 2 units distributed in Arizona and Florida.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a manufacturing defect in a medical device. No illnesses or injuries are reported. Per the severity rubric, FDA Class II recalls without reported adverse events typically score as Moderate.
Plain-English summary
Vero Biotech, LLC is recalling GENOSYL DS (Delivery System) Generation 3 Cassettes, Model Number 602722-01, which are designed to generate and deliver nitric oxide (NO) for inhalation at the point of use.
The cassettes did not meet an in-process flow criterion during manufacturing. Affected units include Lot Code W-0001-2023, with serial numbers GA01T707 and GA01T108 (2 cassettes total).
The affected cassettes were distributed in Arizona and Florida. Healthcare providers and patients currently using these units should contact Vero Biotech, LLC for instructions on replacement.
The recalled product
- 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
- Manufacturer
- Vero Biotech, LLC
- Hazard
- delivery-defect
- flow-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: W-0001-2023
- Cassette serial numbers: GA01T707
- GA01T108
Distribution
Distributed in 2 states:
- AZ
- FL
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