BEUDAMED
    FDA Recall Terminated

    AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

    Recall: Z-0038-2010 · Initiated August 6, 2009

    Recall

    Recall Number
    Z-0038-2010
    Event Number
    53081
    Firm
    Airgas Puritan Medical Puritan Medical Unit
    Product Code
    CAN
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 6, 2009
    Posted
    October 14, 2009
    Terminated
    January 26, 2010
    Address
    259 North Radnor Chester Road, Suite 100, Radnor, PA, 19087

    Description

    AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

    Reason

    Yoke may become displaced. Yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.

    Action

    Airgas issued a Medical Device Removal letter dated 8/6/09 to its customers informing them of the problem and the need to have a yoke back-up plate installed on the Manifold Block Assembly.

    Distribution

    Nationwide distribution.

    Quantity

    208