ClearanceBrief
Recall Z-1849-2014 ยท CAN Regulator, Pressure, Gas Cylinder

Western / Scott Fetzer Company

Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)

DateJun 23, 2014 (initiated Apr 7, 2014)
StatusTerminated
ReasonSeparation events have occurred, including the VIPR separating from the Aluminum cylinder.
Root causeDevice Design
ActionAll initial consignees of subject product were notified by letter dated June 5, 2014 via U.S. mail. Initial consignees were directed to forward copies of the recall notification letters to their contacts in the event the subject product has been further distributed.
Quantity118,325 units
DistributionWorldwide Distribution-USA (nationwide) including Puerto Rico and the states of Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.