Recall Z-0577-2015 ยท CAW Generator, Oxygen, Portable
Invacare Corporation
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.
| Date | Dec 12, 2014 (initiated Sep 23, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | Invacare sent an Urgent - Medical Device Recall letter to customers, dated October 2014. The letter identified the affected product as well as the problem involved. The letter instructed customers to examine their device and confirm that it has an affected serial number, or if service was conducted on the device using IRC5O2V Service Part Number 1165099 with the affected date codes. Customers were asked to immediately contact their dealer or service provider at the number listed, so that a replacement can provided. A service provider or dealer should be contacted with questions regarding t |
| Quantity | 5,963 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020386 | INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 Invacare Corp., Jul 2, 2002 |