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Vero Biotech, LLC Recall 88558

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

Vero Biotech, LLC Recall 88558 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2587-2021
Event ID88558
Event DescriptionGENOSYL DS (Delivery System) console, for use as a vasodilator.
Product TypeDevices
DistributionDistributed within US to Texas and Illinois.
Quantity120 consoles (3 consoles affected)
Recall ReasonManufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
Device Classification20211006
Device Code InfoModel 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)
Center Classification Date20210930
Recall Initiation Date20210909
Recalling FirmVero Biotech, LLC
Initial Notification Letter
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