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.
FDA Recall Z-2099-2019 · Posted None
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Recalling FirmInovo, Inc
Recall StatusTerminated
Product CodeNFB
Date Initiated2019-04-26
Date Terminated2021-04-02
Product Quantity690
Reason for Recall
The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.
Firm 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 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.
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution - AZ, CO, FL, GA, IL, LA, MI, MO, MT, NY, SC, TX, and UT
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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