Lehigh Acres, FL, United States
Inovo, Inc recalls
2 recalls recorded since 2018, most recently on 26 April 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 26 April 2019
- Terminated
- 2 April 2021
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2099-2019
- 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 r
Terminated Class II Medical devices
- Recall started
- 9 October 2017
- Terminated
- 15 September 2023
- Reason
- Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0407-2018
- PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.