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March 29, 2016: “Do Not Use” OxySure Portable Emergency Oxygen System, Warns FDA

Emergency Oxygen System Recall

According to the U.S. Food and Drug Administration’s (FDA) March 29, 2016, Press Release, the OxySure Portable Emergency Oxygen System, Model 615 suffers several device malfunctions, including ineffective oxygen delivery, and chemical reactions in the canisters that could cause them to explode. Due to these dangerous risks, the FDA recommends that consumers, businesses, schools, and health care providers stop using the device immediately.

OxySure Portable Emergency Oxygen System is intended to produce oxygen for emergency use. These devices may be purchased without a prescription and can be used in businesses, schools, and other public places.

FDA Release Severe Warning Against Use of the OxySure Portable Emergency Oxygen System, Calls for Emergency Oxygen System Recall

“Due to 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.

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The Weinberg Law Firm is currently assisting individuals injured by medical devices, including vaginal mesh, power morcellators, IVC filters, and endoscopes/duodenoscopes as well as other devices. Mr. Weinberg also serves as local counsel for mesh lawsuits filed against manufacturers C.R. Bard and Johnson & Johnson consolidated in New Jersey Superior Court in Bergen County. Visit these pages for more information on Essure Lawsuit, or Duodenoscope Infection Lawsuit.

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