The Recall Desk
SevereFDA (Devices)·Z-2587-2021·Announced 2021-10-06

GENOSYL DS vasodilator console recalled for reversed gas lines defect

Vero Biotech recalled 3 GENOSYL DS consoles for a manufacturing defect that reverses gas inlet and outlet lines, causing delivery of toxic nitrogen dioxide instead of therapeutic nitric oxide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall with manufacturing defect resulting in delivery of toxic nitrogen dioxide. Per rubric, FDA Class I recalls are scored minimum 4 (Severe).

Plain-English summary

The GENOSYL DS (Delivery System) console, manufactured by Vero Biotech, LLC, is a medical device used as a vasodilator. Three affected units—with serial numbers G0294, G0378, and MA000065—have been recalled due to a manufacturing defect.

The affected consoles have reversed inlet and outlet gas lines, which causes the device to deliver nitrogen dioxide (NO2), a toxic gas, instead of nitric oxide (NO), the intended therapeutic agent. This defect could result in serious patient harm.

The three affected consoles were distributed to healthcare facilities in Texas and Illinois. Users of these devices should immediately discontinue use and contact Vero Biotech, LLC for instructions regarding replacement, return, or proper disposal.

This is a Class I recall, the most serious classification indicating risk of death or serious injury.

The recalled product

Product
GENOSYL DS (Delivery System) console, for use as a vasodilator.
Manufacturer
Vero Biotech, LLC
Category
Medical Device — Vasodilator Delivery System
Hazard
  • manufacturing-defect
  • nitrogen-dioxide-exposure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • 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)

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category