Recall Z-2099-2019 ยท NFB Conserver, Oxygen
Inovo, Inc
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.
| Date | Apr 26, 2019 |
| Status | Terminated |
| Reason | The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak. |
| Root cause | Process control |
| Action | On April 26, 2019 INOVO sent a recall communication to all their customer with the following instructions: What actions are required? 1) If the product was further distributed, please: a. post this notice in a manner most likely to come to the attention of those customers; b. if possible, directly notify those customers of this voluntary field action and send them a copy of this notice; and c. instruct any and all customers in possession of the products to discontinue use immediately. 2) Quarantine any stock that is still in your current inventory. 3) Return any stock to Inovo, Inc. Inovo will |
| Quantity | 690 |
| Distribution | US Nationwide Distribution - AZ, CO, FL, GA, IL, LA, MI, MO, MT, NY, SC, TX, and UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060751 | INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR Inovo, Inc., Jul 18, 2006 |