Z-0525-2013 Class I Terminated
FDA device recall Z-0525-2013 was initiated by Praxair Inc. on November 16, 2012 and is designated Class I. Reason for recall: Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact. The recall status is terminated (terminated March 24, 2014). Affected quantity: 320,451 units (255,690 US ; 55,884 Canada; 8877 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- January 2, 2013
- Initiation Date
- November 16, 2012
- Termination Date
- March 24, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 320,451 units (255,690 US ; 55,884 Canada; 8877 OUS)
Product Description
Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.
Reason for Recall
Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact.
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries of: Brazil, Canada, China, Columbia, Costa Rica, India, Paraguay and Uruguay.
Code Information
OX M-AEGNGVNTG (US and Canada) and WESPRX-9500 (Global) Cyclinders in service since Jan 2009. Units with a "T" decal (T-teflon) on the fill side of the valve have the rework completed.