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Completed

GENOSYL DS (Delivery System) console, for use as a vasodilator.

FDA Recall Z-2587-2021 · Posted None

Recalling FirmVero Biotech, LLC
Recall StatusCompleted
Product CodeMRN
Date Initiated2021-09-09
Product Quantity120 consoles (3 consoles affected)

Reason for Recall

Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).

Firm Action

On 09/09/2021, Vero Biotech notified customers via certified mail with letter titled, "URGENT: MEDICAL DEVICE RECALL GENOSYL DS LIMITED MANUFACTURING DEFECT." The letter notified the customer of the issue and there were no actions to be taken as the three affected devices were removed from the field prior and replaced.

Root Cause

Process control

Distribution Pattern

Distributed within US to Texas and Illinois.

Official Source

View FDA Recall →

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

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