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U.S. Department of Health and Human Services

Class 1 Device Recall GENOSYL DS

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  Class 1 Device Recall GENOSYL DS see related information
Date Initiated by Firm September 09, 2021
Create Date September 30, 2021
Recall Status1 Open3, Classified
Recall Number Z-2587-2021
Recall Event ID 88558
Product Classification Apparatus, nitric oxide delivery - Product Code MRN
Product GENOSYL DS (Delivery System) console, for use as a vasodilator.
Code Information 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)
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		 Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 120 consoles (3 consoles affected)
Distribution Distributed within US to Texas and Illinois.
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.
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