Praxair, Inc. has issued a recall of its Grab ‘n Go Vantage Portable Oxygen Cylinder units because fires may occur inside the unit causing breakage and the release of oxygen.
The Grab ‘n Go combines an aluminum oxygen cylinder with a regulator valve that releases the oxygen at the right pressure for medical use. But if the cylinder is subject to physical impact—if dropped, kicked, or knocked over—it could catch fire, National Public Radio’s (NPR) Shots health news blog reports. The patient and anyone nearby could be burned and the patient would risk not getting enough oxygen. Serious injury or death could occur.
This is a Class I recall, the most serious recall designation made by the U.S. Food and Drug Administration (FDA). The FDA defines Class I recalls as those “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.”
Praxair has asked customers and distributors to return Grab ‘n Go tanks for servicing and refilling, cautioning them to handle the units with care. Praxair has determined that a particular type of o-ring between the regulator valve and the cylinder is more prone to this type of incident and they will replace these o-rings with Teflon models, NPR reports.
To date, about 50 percent of units in the United States have been retrofitted with the Teflon ring.
The FDA encourages healthcare professionals and patients to report any adverse events related to this product to the MedWatch Safety Information and Adverse Event Reporting Program. To complete and submit a report online, or to download the report form, go to www.fda.gov/MedWatch/report.htm. To request a reporting form by phone, call 1.800.332.1088. Completed forms may be returned to the address on the form or submitted by fax to 1.800.FDA.0178.