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U.S. Department of Health and Human Services

Class 2 Device Recall Medline EndurO2 Oxygen Concentrator without Oxygen Monitor

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  Class 2 Device Recall Medline EndurO2 Oxygen Concentrator without Oxygen Monitor see related information
Date Initiated by Firm March 04, 2008
Date Posted July 23, 2008
Recall Status1 Terminated 3 on June 17, 2010
Recall Number Z-1474-2008
Recall Event ID 47225
510(K)Number K043520  
Product Classification Portable Oxygen Generator - Product Code CAW
Product Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS021; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician.
Code Information Reorder Number: HCS021; All units produced since July 2006.
Recalling Firm/
Manufacturer		 Medline Industries Inc
1 Medline Pl
Mundelein IL 60060-4486
For Additional Information Contact Ms. Kathy Dunne
866-359-1704
Manufacturer Reason
for Recall		 Overheating of Components: There is the potential for an electrical component in the oxygen concentrator to overheat, causing damage to the unit and making it nonfunctional.
FDA Determined
Cause 2		 Device Design
Action Consignees were notified by a letter sent on 3/4/08. The letter informed users that the recalling firm will replace the affected units with new units or issue a credit for the returned recalled units. Distributors were requested to notify their accounts of the recall. The letter requested users to complete and return an enclosed response sheet, indicating the number of units to be replaced or returned for credit. For additional information, contact 866-359-1704.
Distribution Nationwide Distribution
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 = EMG TECHNOLOGY CO., LTD.
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