BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1849-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1849-2014
    Event ID
    68466
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Western / Scott Fetzer Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    April 7, 2014
    Classification Date
    June 23, 2014
    Termination Date
    October 14, 2016
    Address
    875 Bassett Rd, N/A, Westlake, OH, 44145-1142, United States

    Description

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

    Reason

    Separation events have occurred, including the VIPR separating from the Aluminum cylinder.

    Code Info

    Model numbers AGI-4430, ALQ-1877, ALQ-1878, ALQ-1967, ALQ-2033, ALQ-2041, INW-5153, PRX-9310, PRX-9415, PRX-9416, PRX-9416L, PRX-9427, PRX-9427L, RG3001, RG3003, RG4004, RG4004B, RMI-9672, VIT-11660, XRA-3100, XRA-3110, XRA-3110F, XRA-3120, XRA-3120F, XRA-3130, XRA-3200, XRA-3220, XRA-3230, XRA-3230F, XRA-3300, XRA-3310, XRA-3320, XRA-3320F, XRA-3330, XRA-3330F, XRA-3400, XRA-3420, XRA-3420F, XRA-3430, XRA-3430F, XRA-4400, XRA-4430, and XRA-4430P.

    Distribution

    Worldwide 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, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia and the countries of Canada,China, Costa Rica, France, Honduras, India, Ireland, Italy, Japan, Korea (South), Malaysia, Panama, Spain and Taiwan.

    Quantity

    118,325 units