Z-0564-2024 Class II Ongoing

Recalled by Vero Biotech, LLC — Atlanta, GA

Recall Details

Product Type
Devices
Report Date
December 27, 2023
Initiation Date
November 17, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 cassettes

Product Description

VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use

Reason for Recall

Cassette did not meet an 1n-process flow criterion.

Distribution Pattern

US: AZ and FL

Code Information

Lot Code: W-0001-2023, Cassette serial numbers: GA01T707, GA01T108