Medical device manufacturer, Praxair Inc. has issued a medical device safety alert concerning Grab 'n Go Vantage Portable Oxygen Cylinder Unit (Catalogue no.: OX-M-AEGNGVNTG (US and Canada) and WESPRX-9500 (Global).
The manufacturer has initiated a field safety corrective action for the Grab'n Go Vantage Portable Oxygen Cylinder unit because fires may occur inside the cylinder unit causing the wall of the unit to break and release oxygen. The fires are self extinguishing and may be caused by physical impact such as dropping or knocking over the cylinder unit. If a fire occurs, users may experience burns or a lack of oxygen (hypoxia). This product may cause serious adverse health consequences, including death. Customers were instructed to send the affected device to the manufacturer for servicing and refilling after use in accordance with their normal processes.
For further details, please refer to the FDA websites:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0525-2013&w=01022013&lang=eng
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm333846.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 04 January 2013