VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric o
FDA device recall Z-0564-2024 · posted 2023-12-15 · Open, Classified
Recall details
- Recalling firm
- Vero Biotech, LLC
- Reason for recall
- Cassette did not meet an 1n-process flow criterion.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- MRN
- Quantity affected
- 2 cassettes
- Distribution
- US: AZ and FL
- Date initiated
- 2023-11-17
- Date posted
- 2023-12-15
- Location
- Atlanta, GA
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