Invacare Perfecto 2 V Oxygen Concentrator

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 device:  14GF053772-14HF032124 (Sequential serial numbers)

Anesthesiology Devices

2

No

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.

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.