Class 2 Device Recall VERO BIOTECH GENOSYL

• Date Initiated by Firm: November 17, 2023
• Date Posted: December 15, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0564-2024
• Recall Event ID: 93475
• Product Classification: Apparatus, nitric oxide delivery - Product Code MRN
• 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
• Code Information: Lot Code: W-0001-2023, Cassette serial numbers: GA01T707, GA01T108
• Recalling Firm/ Manufacturer: Vero Biotech, LLC; 387 Technology Cir Nw Ste 125; Atlanta GA 30313-2411
• For Additional Information Contact: 908-388-3980
• Manufacturer Reason for Recall: Cassette did not meet an 1n-process flow criterion.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.