BEUDAMED
    FDA Recall Terminated

    Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

    Recall: Z-0061-2010 · Initiated August 10, 2009

    Recall

    Recall Number
    Z-0061-2010
    Event Number
    52847
    Firm
    Western a Scott Fetzer Company
    FEI Number
    1526809
    Product Code
    CAN
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 10, 2009
    Posted
    October 15, 2009
    Terminated
    April 25, 2012
    Address
    875 Bassett Rd, Westlake, OH, 44145-1142

    Description

    Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

    Reason

    The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke connection of another gas type.

    Action

    Western Enterprises issued an "Urgent-Device Recall" notification dated August 20, 2009 informing Consignees of the affected product. Consignees are to contact the firm to request backup plates and installation instructions or request an RGA and shipping instructions for return of the manifold block assembly for modification. For further information, contact Western at 1-800-783-7890.

    Distribution

    Nationwide Distribution -- AL, AR, CA, CO, FL, GA, HI, IL, IN, MA, OH, OR, PA, TX, WA and WI.

    Quantity

    42 cart assemblies containing 84 yoke assemblies (42 Oxygen yokes and 42 Nitrous Oxide yokes)