Recall Z-2099-2019— Inovo, Inc

Name: FDA recall Z-2099-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-26

Class II · Terminated

Class II FDA medical device recall by Inovo, Inc, initiated 2019-04-26, terminated 2021-04-02. It names one FDA 510(k) clearance: K060751. 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: The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak..

Recalling firm: Inovo, Inc
Classification: Class II
Status: Terminated
Initiated: 2019-04-26
Terminated: 2021-04-02
Firm location: Lehigh Acres, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K060751 — INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATORInovo, Inc.·cleared 2006-07-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.