FDA recall Z-2099-2019

Inovo, Inc · Class II · device

Product

Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency and cost saving ratios.

Reason for recall

The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.

Distribution

US Nationwide Distribution - AZ, CO, FL, GA, IL, LA, MI, MO, MT, NY, SC, TX, and UT

Key facts

Status
Terminated
Initiation date
2019-04-26
Report date
2019-08-07
Termination date
2021-04-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lehigh Acres, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2099-2019