Medical Device Safety and Recalls: The FDA Recommends Against Using OxySure Portable Emergency Oxygen System, Model 615: FDA Safety Communication

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: The FDA Recommends Against Using OxySure Portable Emergency Oxygen System, Model 615: FDA Safety Communication

The FDA has determined OxySure Therapeutics, Inc. June 2015 voluntary recall of OxySure replacement cartridges for Model 615 was ineffective. The FDA is recommending consumers, businesses, schools, and health care providers stop using OxySure Portable Emergency Oxygen System, Model 615 because of several device malfunctions, including ineffective oxygen delivery and chemical reactions in the canisters that could cause them to explode.

For additional information, please see: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm492889.htm

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