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Terminated

GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860

FDA Recall Z-1863-2021 · Posted 2021-06-23

Recalling FirmVero Biotech, LLC
Recall StatusTerminated
Product CodeMRN
Date Initiated2021-05-19
Date Terminated2023-10-12
Product Quantity465 units

Reason for Recall

Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.

Firm Action

The firm initiated their recall by visit on 04/07/2021. VERO Clinical Educators are going (or have gone) onsite to the hospitals to physically upgrade the software to v2.2.4. The correction of upgrading the software from v2.2.3 to v2.2.4 began on Wednesday April 7, 2021. The software upgrade is expected to be completed by Friday April 23, 2021. For questions contact VERO Biotech at 1-877-337-4118 or visit the VERO Biotech website at https://www.vero-biotech.com/.

Root Cause

Software design

Distribution Pattern

Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC

Official Source

View FDA Recall →

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

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