RecallRadar

FDA Device recall Z-0564-2024

VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01

On 2023-12-27 the FDA classified a Class II recall of VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01 by Vero Biotech, citing cassette did not meet an 1n-process flow criterion.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0564-2024
ClassificationClass II
Statusongoing
Initiated2023-11-17
Published2023-12-27
Last updated2026-09-13 11:56 UTC
CompanyVero Biotech
DistributionAZ, FL

Product

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

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0564-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.