Recall Z-0407-2018— Inovo, Inc
Class II · Terminated
Class II FDA medical device recall by Inovo, Inc, initiated 2017-10-09, terminated 2023-09-15. It names one FDA 510(k) clearance: K080391. Product: PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S. 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)..
- Recalling firm
- Inovo, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-09
- Terminated
- 2023-09-15
- Firm location
- Lehigh Acres, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.