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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 cartridgessee related information
Date Initiated by FirmJune 12, 2015
Date PostedJuly 24, 2015
Recall Status1 Terminated 3 on October 19, 2020
Recall NumberZ-2253-2015
Recall Event ID 71524
510(K)NumberK052396 
Product Classification Generator, oxygen, portable - Product Code CAW
ProductOxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Code Information lots 61-65
FEI Number 3004167951
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
ActionThe 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 Commerce1005 units
DistributionNationwide throughout the US and Chile, Trinidad, China
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CAW
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