Reported Dec 17, 2014 · Terminated

Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a…

Invacare Corporation

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: Invacare Corporation · 1200 Taylor St · Elyria, OH · 44035-6248

Is this the product you have?

  • Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.
Lot codes and dates
  • The defective sieve bed subassembly manufactured from 7/31/2014 to 8/19/2014 impacts the finished device- IRC5PO2V and Service Part Number-1165099. The serial number range
  • is as follows for the finished device14GF053772-14HF032124 (Sequential serial numbers)
Amount recalled
5,963

Where it was sold

Why it was recalled

It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration.

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 Jun 18, 2015 · Data as of Sep 19, 5:26 PM UTC

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