Summary
The FDA issued a Class I for GENOSYL DS (Delivery System) console, for use as a vasodilator. by Vero Biotech, LLC. Reason: Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO.
Details
Source
Device Recall
External ID
Z-2587-2021
Action Date
2021-10-06
Status
Completed
Category
device
Product Description
GENOSYL DS (Delivery System) console, for use as a vasodilator.
Lot/Code Info: Model Number: 601588-01, Serial Numbers G0294 (UDI (01)00850000962026(11)200728(21)G0294); G0378 (UDI (01)00850000962026(11)200917(21)G0378); and MA000065 (UDI (01)00850000962026(11)210511(21)MA000065)
Quantity Affected: 120 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).
Distribution
Distributed within US to Texas and Illinois.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-09
Company
Atlanta, GA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Vero Biotech, LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Vero Biotech, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vero Biotech, LLC have FDA actions?
Vero Biotech, LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2587-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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