The FDA has issued a medical device recall communication regarding the OxyTOTE Portable Oxygen Unit manufactured and distributed between the dates of January 1, 2009 to September 30, 2014 by the Western/Scott Fetzer Company.
Reports have shown that if the portable oxygen unit is mishandled or dropped, "the oxygen cylinder may ignite causing an internal flash fire and the canister to burst."
There have been over 160,00 units distributed in the US. The recall urges users to locate and identify any OxyTOTE/oxyQuik/AirTOTE product and to contact your OxyTOTE/oxyQuik/AirTOTE distributor or Medical Gas Provider to see if remediation of the product is necessary.
The company has received two reports of incidents in which the oxygen unit has malfunctioned causing an injury and a death. Please click here for specific details on the recall.
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