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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