Inovo Purefill Oxygen Compressor Recalled for Operational Failure Risk
Inovo, Inc. is recalling 117 Inovo Purefill Oxygen Compressor Model PF1100 units because the device can fail during operation.
What this means for you
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 involves a medical device with a risk of harm (operational failure) where no specific injuries or illnesses have been reported, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Inovo, Inc. is recalling 117 units of the Inovo Purefill Oxygen Compressor Model PF1100. This device is an oxygen refill machine designed to attach to an oxygen concentrator to refill portable oxygen cylinders.
The recall was initiated because the device can fail during operation. The affected units were distributed nationwide to the states of AL, AR, CT, FL, IA, KS, KY, MD, MI, MN, MO, NE, NJ, NV, NY, OH, RI, SC, TN, TX, UT, and WA. The affected serial numbers range from PFDM1500003 through PFDM1500390 and PFDM1600391 through PFMD1600843.
Consumers should check their serial numbers against the affected range. If the device is affected, they should stop using it and contact Inovo, Inc. for further instructions.
The recalled product
- Product
- INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
- Manufacturer
- Inovo, Inc
- Hazard
- Affected units
- 117
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial #'s: PFDM1500003 thru PFDM1500390 and PFDM1600391 thru PFMD1600843.
Distribution
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