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U.S. Department of Health and Human Services

Class 2 Device Recall OxySure Model 615 disposable replacement cartridges

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  Class 2 Device Recall OxySure Model 615 disposable replacement cartridges see related information
Date Initiated by Firm June 12, 2015
Date Posted July 24, 2015
Recall Status1 Terminated 3 on October 19, 2020
Recall Number Z-2253-2015
Recall Event ID 71524
510(K)Number K052396  
Product Classification Generator, oxygen, portable - Product Code CAW
Product OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Code Information lots 61-65
Recalling Firm/
Manufacturer		 Oxysure Systems, Inc.
10880 John W Elliott Dr Ste 600
Frisco TX 75033-3281
For Additional Information Contact
972-294-6555
Manufacturer Reason
for Recall		 Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm will notify their affected customers via email beginning the week of 6/15/15. The recall notification will have a response for to be completed by the consignee. The recall notification calls for the customers to dispose of the affected product according to the MSDS.
Quantity in Commerce 1005 units
Distribution Nationwide throughout the US and Chile, Trinidad, China
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 = OXYSURE SYSTEMS, INC.
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