Inovo Single Luman Conserver Recalled for Potential Pressure Gauge Dislodgement
Inovo, Inc. is recalling 690 Single Luman Conservers because the pressure gauge may dislodge from the mount, creating a leak.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential leak in a medical device that regulates oxygen flow, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Inovo, Inc. is recalling 690 units of the Inovo Single Luman Conserver. This medical device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales.
The recall was initiated because the pressure gauge (manometer) may dislodge from the threaded insertion/mount, which can create a leak. The affected units were distributed nationwide in Arizona, Colorado, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, Montana, New York, South Carolina, Texas, and Utah.
Consumers should check the serial number of their device against the list of affected units provided by the manufacturer. If the device is affected, users should stop using it and contact Inovo, Inc. for instructions on repair or replacement.
The recalled product
- 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.
- Manufacturer
- Inovo, Inc
- Category
- Medical Device — Oxygen Therapy
- Hazard
- Affected units
- 690
Distribution
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