|OxySure Portable Emergency Oxygen System, Model 615--Courtesy of OxySure|
Back in June 2015, OxySure Therapeutics recalled replacement cartridges for its OxySure Portable Emergency Oxygen System, Model 615. But the FDA determined the action was ineffective and put out a safety alert Tuesday calling for consumers, healthcare providers, businesses and schools to immediately stop using the device.
The company pulled the cartridges last summer because they did not deliver enough oxygen. FDA standards require them to deliver at least 6 liters per minute of oxygen for a minimum of 15 minutes. The agency deemed it a Class II recall, where use or exposure to the product "may cause temporary or medically reversible adverse health consequences."
Now, the FDA is citing insufficient oxygen flow, rebreathing of exhaled gases, burns, bruising and exposure to chemicals in its alert. Chemical reactions in the canisters could also lead to explosions, the agency said.
The device can be purchased without a prescription and can be used in a variety of public places, including schools, businesses, gyms and airports. Since 2013, OxySure has sold upwards of 1,000 units in the U.S. While the company markets add-ons and accessories for the emergency oxygen system, it is the only device that it sells.
The FDA inspected OxySure's facility in September 2014 and found the device's oxygen delivery to be insufficient and in December 2014 served up a warning letter, saying the firm "failed to identify, control, evaluate" batches of OxySure canisters that did not meet its oxygen flow rate specifications. A year after the initial inspection, the device's oxygen flow rate failed again to meet FDA standards. Despite the June 2015 recall, the device remained available for use by consumers at certain sites, the FDA said. In December, the agency followed up with a recall ineffective letter asking OxySure to take steps to ensure that the device was not being used by consumers.