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Class 2 Device Recall HomeFill Oxygen Compressor IOH200 Homefill |
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Date Initiated by Firm |
January 11, 2011 |
Date Posted |
February 24, 2011 |
Recall Status1 |
Terminated 3 on November 21, 2011 |
Recall Number |
Z-1423-2011 |
Recall Event ID |
57629 |
510(K)Number |
K003939
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Product Classification |
Generator, oxygen, portable - Product Code CAW
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Product |
HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF034084, 10JF034085, 10JF034086, 10JF034087, 10JF034088, 10JF034089, 10JF034090, 10JF034091, 10JF034092, 10JF034093, 10JF034094, 10JF034095, 10JF034096, 10JF034097, 10JF034098, 10JF034099, 10JF034100, 10JF034101, 10JF034102, 10JF034103, 10JF034104, 10JF034105, 10JF034106, 10JF034107, 10JF034108, 10JF034109, 10JF034111, 10JF034112, 10JF034113, 10JF034114, 10JF034115, 10JF034116, 10JF034117, 10JF034119, 10JF034120, 10JF034121, 10JF034122, 10JF034123, 10JF034124, 10JF034125, 10JF034126, 10JF034127, 10JF034128, 10JF034129, 10JF034130, 10JF034131, 10JF034132, 10JF034133, 10JF034134, 10JF034135, 10JF034136, 10JF034177, 10JF034178, 10JF034179, 10JF034180, 10JF034181, 10JF034182, 10JF034183, & 10JF034184.
The IOH 200 Homefill is an electromechanical, prescription device designed for use in the home. Its intended function and use is to provide supplemental oxygen to patients and to supply pressurized oxygen to fill cylinders for the patients personal ambulatory use. |
Code Information |
The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF034084, 10JF034085, 10JF034086, 10JF034087, 10JF034088, 10JF034089, 10JF034090, 10JF034091, 10JF034092, 10JF034093, 10JF034094, 10JF034095, 10JF034096, 10JF034097, 10JF034098, 10JF034099, 10JF034100, 10JF034101, 10JF034102, 10JF034103, 10JF034104, 10JF034105, 10JF034106, 10JF034107, 10JF034108, 10JF034109, 10JF034111, 10JF034112, 10JF034113, 10JF034114, 10JF034115, 10JF034116, 10JF034117, 10JF034119, 10JF034120, 10JF034121, 10JF034122, 10JF034123, 10JF034124, 10JF034125, 10JF034126, 10JF034127, 10JF034128, 10JF034129, 10JF034130, 10JF034131, 10JF034132, 10JF034133, 10JF034134, 10JF034135, 10JF034136, 10JF034177, 10JF034178, 10JF034179, 10JF034180, 10JF034181, 10JF034182, 10JF034183, & 10JF034184. |
Recalling Firm/ Manufacturer |
Invacare Corporation 1 Invacare Way PO Box 4028 Elyria OH 44035
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For Additional Information Contact |
440-329-6595
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Manufacturer Reason for Recall |
Invacare Corporation decided to recall the products because risk analysis reveals that inadequate clearance between a motor ground clip and the motor windings may result in an increased risk for shock to service personnel. It also may result in contact with the motor winding, resulting in a shorted winding; this condition has the potential to result in motor failure/shutdown or to cause the motor
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FDA Determined Cause 2 |
Other |
Action |
The firm, INVACARE Corp., sent an "URGENT PRODUCT RECALL: IOH 200 Homefill Recall" letter dated January 10, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to "immediately examine their inventory and quarantine product subject to recall. In addition, if they may have further distributed this product, please identify their customers and notify them at once of this product recall." The customers were also instructed to complete and return an enclosed response form. Note: All product is to be return to the recalling firm.
If you have any questions, contact the Manager, Regulatory Affairs at (440) 329-6356. |
Quantity in Commerce |
62 Compressors |
Distribution |
Nationwide distribution: USA including states of: FL, GA, KY, LA, MO, NC, NE, NJ and SC. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = CAW and Original Applicant = INVACARE CORP.
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