  |
Praxair Inc., Grab ‘n Go Vantage Portable Oxygen Cylinder Units: Class I Recall - Risk of Fire Inside Cylinder Unit
AUDIENCE: Risk Manager
ISSUE: Praxair Inc. issued a recall of 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.
BACKGROUND: The Grab 'n Go Vantage Portable Oxygen Cylinder unit consists of an oxygen container and pressure regulator (valve). The pressure regulator (valve) is intended for medical purposes and is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure.
RECOMMENDATION: On November 26, 2012, Praxair, Inc. sent "Medical Device Correction" letters to customers and distributors describing the product, problem, and actions to be taken. Customers were also instructed to send Grab’n Go Vantage Portable Oxygen Cylinder units to Praxair, Inc. for servicing and refilling after use in accordance with their normal processes.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the medWatch safety alert, including a link to the recall notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
