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| Oxytote and an oxygen canister--Courtesy of Western Enterprises |
The FDA dubbed Western Enterprises' Oxytote Oxygen System regulators potentially deadly, deeming the corrective action of its device a Class 1 recall, reserved for situations "in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
According to the FDA, the Ohio-based company has become aware of the possibility of ignition and explosion of compressed gas oxygen cylinders due to an unspecified problem with component design and selection. More than 160,000 units are affected across the U.S. and various countries, including Chile, Germany, Lebanon, Macau and Singapore.
Western sent a letter to customers in January instructing them to contact the company if they have any off the affected devices, which are identified in the notice by their model numbers. Western said it will provide product remediation, according to the FDA. The recall is ongoing.
According to the product website, Oxytote reduces the risk of accidents involving compressed gas by indicating how much oxygen is available in the canister and enabling customizable flow rates of oxygen administration.
The device sits atop oxygen canisters. The oxygen flows through the device as it exits the container.
The recall is voluntary. The FDA adds corrective actions to its recall database to inform the public of product mishaps and classifies them into one of three categories based on severity.
- read the recall notice