March 29, 2016
- Consumers, health care providers, businesses and schools that have or are considering purchasing the OxySure Portable Emergency Oxygen System, Model 615
- Health care providers who recommend OxySure Portable Emergency Oxygen System, Model 615
OxySure Portable Emergency Oxygen System is intended to produce oxygen for emergency use. No prescription is required.
The FDA has determined OxySure Therapeutics, Inc. June 2015 voluntary recall of OxySure replacement cartridges for Model 615 was ineffective. The FDA is recommending consumers, businesses, schools, and health care providers stop using OxySure Portable Emergency Oxygen System, Model 615 because of several device malfunctions, including ineffective oxygen delivery and chemical reactions in the canisters that could cause them to explode.
Summary of Problem and Scope:
The FDA has received multiple complaints and reports of adverse events associated with use of this device including insufficient oxygen flow, re-breathing of exhaled gases, burns, bruising (contusions) and exposure to chemicals.
Since June 2013, OxySure Therapeutics, Inc. has distributed at least 1,000 units of the OxySure Portable Emergency Oxygen System, Model 615 nationwide. These devices may be purchased without a prescription and can be used in businesses, schools, and other public places (e.g.., gyms, shopping malls, and airports).
During a September 2014 FDA inspection of an OxySure Therapeutics, Inc. facility, the company’s internal testing revealed the device’s oxygen flow rate to be too low and did not meet the FDA-cleared minimum specification of 6 liters per minute for a minimum of 15 minutes.
In December 2014, the FDA issued a warning letter to OxySure Therapeutics, Inc. for deficiencies in addressing oxygen flow rate problems.
In June 2015, OxySure Therapeutics, Inc. initiated a voluntary recall of OxySure replacement cartridges for Model 615, lots 61-65 because the oxygen flow rate did not meet the labeled specification. On June 22, 2015, OxySure Therapeutics, Inc. issued a “Field Correction Action Notification” informing customers of the problem and instructing them to review their inventory and dispose of the affected product.
During a follow-up inspection of the manufacturing facility in September 2015, the device’s oxygen flow rate again failed to meet the FDA-cleared minimum specification of 6 liters per minute for a minimum of 15-minutes.
In addition, an FDA recall audit check determined the June 2015 recall was ineffective because the recalled products were observed at user sites visited by the FDA and available for use by customers. On December 18, 2015, the FDA issued a "Recall Ineffective Letter" to OxySure Therapeutics, Inc. detailing the FDA’s concerns and requesting the firm identify corrective actions to ensure the defective product was not being used by consumers.
Due to the adverse event reports to the FDA and the company’s failure to address the device’s safety issues noted during inspections and in the FDA’s warning letter, the FDA is concerned that patients and other users of OxySure Portable Emergency Oxygen System, Model 615 are at risk for serious adverse health consequences, such as burns and death.
The FDA recommends customers stop using the OxySure Portable Emergency Oxygen System, Model 615 and immediately transition to an alternative FDA-cleared emergency oxygen device (searchable under Product Code "CAW").
As outlined above, since September 2014, the FDA has been working with OxySure Therapeutics, Inc. to address concerns about the safety and effectiveness of the OxySure Portable Emergency Oxygen System, Model 615.
The FDA will continue to work with OxySure Therapeutics, Inc. to bring these devices into regulatory compliance and will keep the public informed if significant new information becomes available.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks related to the use of medical devices. If you suspect or experience a problem with OxySure Portable Emergency Oxygen System, Model 615, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
If you have questions about this communication, please contact CDRH’s Division of Industry Communication and Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041, or 301-796-7100.