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U.S. Department of Health and Human Services

Class 2 Device Recall Invacare Perfecto 2 V Oxygen Concentrator

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  Class 2 Device Recall Invacare Perfecto 2 V Oxygen Concentrator see related information
Date Initiated by Firm September 23, 2014
Date Posted December 12, 2014
Recall Status1 Terminated 3 on June 18, 2015
Recall Number Z-0577-2015
Recall Event ID 69441
510(K)Number K020386  
Product Classification Generator, oxygen, portable - Product Code CAW
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.
Code Information 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) 
Recalling Firm/
Manufacturer		 Invacare Corporation
1200 Taylor St
Elyria OH 44035-6248
For Additional Information Contact
440-329-6595
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 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 the instructions.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAW and Original Applicant = INVACARE CORP.
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