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Open, Classified

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

FDA Recall Z-0564-2024 · Posted 2023-12-15

Recalling FirmVero Biotech, LLC
Recall StatusOpen, Classified
Product CodeMRN
Date Initiated2023-11-17
Product Quantity2 cassettes

Reason for Recall

Cassette did not meet an 1n-process flow criterion.

Firm 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.

Root Cause

Process control

Distribution Pattern

US: AZ and FL

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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