BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1849-2014 · Initiated April 7, 2014

    Recall

    Recall Number
    Z-1849-2014
    Event Number
    68466
    Firm
    Western Scott Fetzer Company
    FEI Number
    1526809
    Product Code
    CAN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 7, 2014
    Posted
    June 23, 2014
    Terminated
    October 14, 2016
    Address
    875 Bassett Rd, Westlake, OH, 44145-1142

    Description

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

    Reason

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

    Action

    All 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.

    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