Recall Z-2099-2019
Inovo, Inc · initiated April 26, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: SERIAL NUMBERS BY MODELS: C0019802 IN6505-L-Blue C0019803 IN6505-L-Blue C0019804 IN6505-L-Blue C0019805 IN6505-L-Blue C0019806 IN6505-L-Blue C0019808 IN6505-L-Blue C0019820 IN6505-L-Blue C0019825 IN6505-L-Blue C0019826 IN6505-L-Blue C0019827 IN6505-L-Blue C0019828 IN6505-L-Blue C0019831 IN6505-L-Blue C0019833 IN6505-L-Blue C0019834 IN6505-L-Blue C0019874 IN6505-L-Blue C0019894 IN6505-L-Blue C0019895 IN6505-L-Blue C0019899 IN6505-L-Blue C0019917 IN6505-L-Blue C0019918 IN6505-L-Blue C0019884 IN6505-L-Blue C0019889 IN6505-L-Blue C0019893 IN6505-L-Blue C0019897 IN6505-L-Blue C0019910 IN6505-L-Blue C0019911 IN6505-L-Blue C0019913 IN6505-L-Blue C0019914 IN6505-L-Blue C0020421 IN6505-L-Blue C0019807 IN6505-L-Blue C0019818 IN6505-L-Blue C0019832 IN6505-L-Blue C0019836 IN6505-L-Blue C0019837 IN6505-L-Blue C0019838 IN6505-L-Blue C0019873 IN6505-L-Blue C0019883 IN6505-L-Blue C0019892 IN6505-L-Blue C0019896 IN6505-L-Blue C0019903 IN6505-L-Blue C0019909 IN6505-L-Blue C0019916 IN6505-L-Blue C0020405 IN6505-L-Blue C0020416 IN6505-L-Blue C0020417 IN6505-L-Blue C0020431 IN6505-L-Blue C0020432 IN6505-L-Blue C0019890 IN6505-L-Blue C0019891 IN6505-L-Blue C0019912 IN6505-L-Blue C0019915 IN6505-L-Blue…
Reason for recall
The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.
FDA-determined cause: Process control
Action taken
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 FieldAction@drivemedical.com 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 FieldAction@drivemedical.com. For urgent assistance, please call 1-877-224-0946, ext. 4282.
Details
- Recall number
- Z-2099-2019
- Initiated
- April 26, 2019
- Terminated
- April 2, 2021
- Product code
- NFB – Conserver, Oxygen
- Quantity
- 690
- Distribution
- US Nationwide Distribution - AZ, CO, FL, GA, IL, LA, MI, MO, MT, NY, SC, TX, and UT
- Recalling firm
- Inovo, Inc, Lehigh Acres, FL