Device recall: Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank…
Class II FDA enforcement event 82793. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Inovo, Inc started this device recall on 26 Apr 2019. The firm address in the FDA record is in Lehigh Acres, FL. FDA put the recall in Class II. FDA event 82793 has 1 product record. The first FDA enforcement report date is 7 Aug 2019. The record gives the status Terminated, with the termination date 2 Apr 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide Distribution - AZ, CO, FL, GA, IL, LA, MI, MO, MT, NY, SC, TX, and UT
Recalling firm
Inovo, Inc, Lehigh Acres, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2099-2019 | 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. | 690 | Class II | Terminated | 7 Aug 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Oct 2017 | PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S | Device | Class II | 1 |
| 21 Jul 2016 | INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2099-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 82793. https://recallregister.com/fda/ii/82793/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide Distribution - AZ, CO, FL, GA, IL, LA, MI, MO, MT, NY, SC, TX, and UT
- What quantity of product is in FDA event 82793?
- The FDA record gives this quantity:
690
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.