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
This recall is currently active, issued December 15, 2023. It was issued by Vero Biotech, Llc.
- Company
- Vero Biotech, Llc
- Recall Initiated
- November 17, 2023
- Posted
- December 15, 2023
- Recall Number
- Z-0564-2024
- Quantity
- 2 cassettes
- Firm Location
- Atlanta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Cassette did not meet an 1n-process flow criterion.
Distribution
US: AZ and FL
Lot / Code Info
Lot Code: W-0001-2023, Cassette serial numbers: GA01T707, GA01T108
Root Cause
Process control
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.