Reported Dec 21, 2016 · Terminated

INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator…

Inovo, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Inovo, Inc · 401 Leonard Blvd N · Lehigh Acres, FL · 33971-6302

Is this the product you have?

  • INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
Lot codes and dates
  • Serial #'s: PFDM1500003 thru PFDM1500390 and PFDM1600391 thru PFMD1600843.
Amount recalled
117 units

Where it was sold

Why it was recalled

Device can fail during operation.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 16, 2019 · Data as of Sep 19, 6:03 PM UTC

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