Recall Z-0525-2013 ยท CAN Regulator, Pressure, Gas Cylinder
Praxair Inc.
Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.
| Date | Dec 21, 2012 (initiated Nov 16, 2012) |
| Status | Terminated |
| Reason | Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact. |
| Root cause | Device Design |
| Action | The firm, PRAXAIR, sent a "MEDICAL DEVICE CORRECTION" letter dated November 26, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the Grab'n Go operating instructions provided in the letter which include: storing the Grab'n Go systems indoors in a safe area; never store a system in an elevated location; handle systems safely and avoid jarring or dropping the system and locate at the following web link: www.praxair.com/GNGinstructions. The customers were also instructed to ensure that all of the Grab'n Go units tha |
| Quantity | 320,451 units (255,690 US ; 55,884 Canada; 8877 OUS) |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Brazil, Canada, China, Columbia, Costa Rica, India, Paraguay and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.