BEUDAMED
    FDA Recall Terminated

    BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator with Regulator and Gauge.

    Recall: Z-0556-04 · Initiated September 12, 2003

    Recall

    Recall Number
    Z-0556-04
    Event Number
    27419
    Firm
    Instrumentation Industries Inc
    FEI Number
    2518436
    Product Code
    BTM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 12, 2003
    Posted
    February 27, 2004
    Terminated
    February 26, 2004
    Address
    2990 Industrial Blvd, Bethel Park, PA, 15102

    Description

    BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator with Regulator and Gauge.

    Reason

    possible external debris in the on/off plunger.

    Action

    The recalling firm notified all customers via telephone to inform them of the problem and the need to return the product when received. The recalling firm issued recall letters dated 9/17/03 to their direct accounts informing them of the problem. The also informed the account that a stop shipment had been ordered but if they receive the product they need to return it immediately.

    Distribution

    The products were shipped to medical facilities in CA, FL, GA, NY, OH, OR, TX, and UT.

    Quantity

    46 units