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Invacare Corporation recalls Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contain
Recalled December 17, 2014 · FDA recall Z-0577-2015 · Invacare
Hazard
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. · FDA Class II
Units
5,963
Sold at
Nationwide Distribution -- FL, NJ, GA, RI, PA, MI, CA, MA, IN, WA, CT, VA, NC, MO, AZ, CO, MS, MI, WI, TN, NH, IL, LA, OK, HI, KY, NE, SC, TX, IA, IN, and MS.
Description
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.
Product
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.
Manufacturer(s)
Invacare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →