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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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
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