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
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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 |
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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
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