OxySure Therapeutics Inc., a medical technology solution company, has issued a response to the US Food and Drug Administration (FDA) organisation after it recalled thousands of the company’s portable oxygen (O2) devices last month.
The FDA revealed several device malfunctions, including ineffective O2 delivery and chemical reactions in the canisters that could cause them to explode. After receiving multiple complaints and reports of adverse affects associated with the use of this instrument, including insufficient O2 flow, re-breathing of exhaled gases, burns and exposure to chemicals, the association issued the recall.
We are sure that the thousands of people saved over the years with our product also disagree…FDA’s sudden and unprompted notice is not only full of inaccuracies; it is plainly arbitrary and capricious
The company’s legal team has addressed the recent safety notice of the OxySure Model 615, with Mazin Sbaiti, Esq., an attorney with Friedman and Feiger LLP and OxySure’s litigation counsel, insisting, “OxySure strongly disagrees with both the content and import of the FDA’s 29th March, 2016, safety notice about the OxySure Model 615 device.”
“We are sure that the thousands of people saved over the years with our product also disagree. Notably, the notice cites no evidence that shows that the OxySure Model 615 device does not perform up to FDA standards, or that it fails to perform as intended – indeed, the record of usage to save lives would suggest otherwise.”
“We continue to stand by our product, its innovativeness and the value it brings to society. FDA’s sudden and unprompted notice is not only full of inaccuracies; it is plainly arbitrary and capricious.”
Off the market
But despite its defiant claims, the company is still taking the dud model off the market, with Julian Ross, Chairman of the US based-business, stating, “From a strategic standpoint, we like the idea of using this opportunity to take a step back, take Model 615 offline and accelerate our plans for Generation 2.”
The company’s plans for Generation 2 of the device include additional precautions against user error and intentional or unintentional abuse of the product, with the instrument set to come to market later this year.
It is understood that since June 2013, the Texas-based medical technology company has distributed at least one thousand units of the faulty OxySure Model 615 throughout the US.