Recall Z-0407-2018 ยท CAW Generator, Oxygen, Portable
Inovo, Inc
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
| Date | Oct 9, 2017 |
| Status | Terminated |
| 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). |
| Root cause | Under Investigation by firm |
| Action | The firm initiated their recall by letter on 10/09/2017. The letter stated the following: "Actions to be Taken: Based on our distribution records, your firm has received one or more Pure Stationary Oxygen Concentrators. We respectfully request that you take the following actions: 1. Contact all patients and customers that currently have Pure Stationary Oxygen Concentrators in their homes or facilities and inform them of this recall. Retrieve the oxygen concentrators from their homes or facilities. 2. Destroy all Pure Stationary Oxygen Concentrator(s) in accordance with the following steps: |
| Quantity | 13,140 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080391 | DRIVE SOLSTICE OXYGEN CONCENTRATOR Medical Depot, Mar 18, 2008 |