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.
Recall
- Recall Number
- Z-2099-2019
- Event Number
- 82793
- Firm
- Inovo, Inc
- FEI Number
- 3000719543
- Product Code
- NFB
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 26, 2019
- Terminated
- April 2, 2021
- Address
- 401 Leonard Blvd N, Lehigh Acres, FL, 33971-6302
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.
The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.
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 supply return shipping labels as requested. 4) Please sign and date the accompanying acknowledgement form upon receipt. Please scan and send the signed form to the Inovo, Inc. Recall coordinator, Patricia Beja, at [email protected] or return it in the self-addressed stamped envelope provided. 5) To obtain a replacement for any returned conservers please return the Recall Acknowledgement paperwork. 6) Please forward your internal Recall protocols for our records. Will replacement product be available? Replacements will be made as inventory is available. We are offering as replacement new unit or the Bonsai OM-812. We will expedite consumer replacements as required. If you have any questions concerning these instructions, please email Inovo, Inc. Recall coordinator Patricia Beja at [email protected]. For urgent assistance, please call 1-877-224-0946, ext. 4282.
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