The FDA today released a safety letter warning against the use of OxySure Therapeutic’s Portable Emergency Oxygen System model 615.
The safety communication comes based on complaints of adverse events related to insufficient oxygen flow, re-breathing of exhaled gases, burns, bruising and exposure to chemicals.
The federal watchdog said that over 1,000 of the units have been distributed across the U.S., and that the units can be purchased without a prescription for use publicly or privately.
The agency said that an inspection in September 2014 identified that the device’s oxygen flow rate was too low and did not meet the FDA-cleared minimum specification of 6 liters per minute for 15 minutes.
OxySure Therapeutics was served with a warning letter for the issues, and shortly after initiated a voluntary recall of the cartridges for the Model 615 version of the device.
A follow-up inspection met the same outcome, with OxySure again failing to meet FDA cleared minimum specifications.
An FDA recall audit check later determined that the earlier recall was ineffective because the recalled products were observed at user sites visited by the FDA and available for use to customers.
The agency sent a “Recall Ineffective Letter” to OxySure detailing its concerns and requesting corrective action, and is now advising against the use of the device.
“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 wrote in its safety communication.
The FDA said it will continue to work with OxySure to “bring these devices into regulatory compliance.”