BEUDAMED
    FDA Recall Terminated

    Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23 Fairfield Place, West Caldwell, NJ 07006. Accessory for 700 Series 754/754m Ventilators during MRI examinations

    Recall: Z-3080-2011 · Initiated May 27, 2011

    Recall

    Recall Number
    Z-3080-2011
    Event Number
    59400
    Firm
    Impact Instrumentation, Inc.
    FEI Number
    1220908
    Product Code
    cbk
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    May 27, 2011
    Posted
    August 29, 2011
    Terminated
    May 23, 2013
    Address
    23 Fairfield Pl, West Caldwell, NJ, 07006-6206

    Description

    Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23 Fairfield Place, West Caldwell, NJ 07006. Accessory for 700 Series 754/754m Ventilators during MRI examinations

    Reason

    Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k).

    Action

    Impact Instrumentation Inc. sent an "Urgent Product Recall" dated May 27, 2011 to all affected customers. The letter informed customers the product is not a cleared product and to return the product back to Impact Inst. for credit. A notification form is included in the letter to be return to the firm. For information on this recall contact the firms Customer Service Department at (800) 969-0750, 8:30 am to 5:00 pm EST.

    Distribution

    Nationwide Distribution; including the states of CA, FL, IL, NJ, OH, TX, UT, MN, MO, MS, OH, OR, TX, AR, and PA.

    Quantity

    492 units